February 15, 2008
Local and National News
Ottawa Targets Hospital Superbugs
Conquering AIDS — If We Have A HAART
AIDS Advocates Call For Support As Epidemic Grows In Aboriginal Communities
Fair Play Or Morality Play?
Liberal Leader Dion Indicates Vancouver Safe Injection Site Is OK

International News
House GOP Opposes AIDS Program Changes
Alleged Rape Victim Is HIV Positive
HIV Infections Up 20% In Sweden
African Women Slam Abuse of Females With HIV/AIDS
Egypt: Stop Criminalizing HIV

Studies & Treatment News
Scientists Find New Receptor for HIV
Probiotics May Ease Gut Problems In People With HIV/AIDS
HIV Drugs Make Breast-Feeding Safer, Study Finds
Diabetes Study Partially Halted After Deaths
News from the Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston

Links of Interest
Death March
The HIV/AIDS eNews is published by the British Columbia Persons With AIDS Society. This publication is a compilation of various articles collected from various news sources. Opinions and information expressed are those of the individual authors and not necessarily those of the Society.
WHAT’S NEW @ BCPWA

The 7th Annual AccolAIDS Awards Gala is coming soon.
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The AccolAIDS Awards honour the extraordinary achievements and dedication of organizations, businesses, groups and individuals responding to the AIDS epidemic in British Columbia, and the thousands of people living in BC who are affected.
For more information on [ Nominating an AccolAIDS Hero ]
The AccolAIDS Award Gala will be held on April 13, 2008
at the Fairmont Hotel Vancouver.




Simply Positive: New easy-to read treatment information resources

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Winner receives a $1000 honorarium! Are you a Canadian HIV-positive artist? Want to obtain unprecedented exposure for you and your artwork? Submit your artwork to be considered as the centerpiece of the 2008 AIDS Walk for Life’s creative design! Deadline extended to February 15th, 2008!
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Local & National News

Ottawa Targets Hospital Superbugs
Health agency acts as infection rate soars

February 4, 2008

The federal government is launching a national effort targeting the superbug methicillin-resistant Staphylococcus aureus in its bid to reduce the number of hospital-acquired infections that kill thousands of Canadians each year.

An estimated 220,000 Canadians develop hospital-acquired infections each year, of which MRSA is one type, according to Canadian Nosocomial Infection Surveillance Program figures. About 8,000 people die of them annually.

Until now, efforts to reduce the prevalence of superbug infections have been largely left to individual hospitals, which resulted in inconsistent policies and outcomes. The annual death toll of hospital-acquired infections dwarfs that of the 2003 SARS outbreak, which killed 44 people nationwide.

By targeting MRSA, Howard Njoo of the Public Health Agency of Canada said it is making patient safety in this country's hospitals a priority.

Superbugs are of such concern that almost all acute-care Canadian hospitals and nursing homes now applying for accreditation will have to provide their rates of MRSA or Clostridium difficile. The new requirement of the Canadian Council on Health Services Accreditation, effective as of last month, will compel those organizations to track the rate of those two types of bacteria as part of the accreditation process.

And although accreditation is voluntary, 99 per cent of Canada's acute-care hospitals participate, as do many nursing homes, some community health centres, home-care organizations and other health-care facilities.

"We recognize that both in the community and in the health-care setting, trying to decrease the transmission of infections is very important," Dr. Njoo, director-general of the agency's Centre for Communicable Diseases and Infection Control, said.

Hand washing and appropriate use of antibiotics are two measures that help reduce various forms of hospital-acquired infections, including MRSA, Dr. Njoo said.

While hand hygiene is a crucial and obvious step to reducing infections, prodding those who provide care to scrub up has been maddeningly difficult: only 40 per cent of Canadian health-care workers properly wash their hands.

Other measures proven to help reduce MRSA include screening patients for the superbug upon admission to hospital, isolating hospital patients who have it, proper cleaning of hospital rooms, and ensuring hospital visitors and health-care workers who come into contact with those who have MRSA don gloves, gowns and masks.

The federal effort - the largest national effort to date - comes after it said in September that it would develop a plan by January on how to reduce the staggering number of infections occurring in the nation's hospitals. At the time, it was considering three superbugs: MRSA, vancoymycin-resistant enterococci and C. difficile. In the end, MRSA was selected, in part, because it is highly responsive to proper hand hygiene.

Phil Hassen, chief executive officer of the Canadian Patient Safety Institute, said MRSA is causing a lot of grief in Canadian hospitals, adding that "this is a safety issue; this is about preventing harm to people."

The federal government has not yet set a target on how many MRSA infections it would like to reduce. Joanne Laalo, past president of the Community and Hospital Infection Control Association of Canada, the group co-leading the superbug initiative with the government, stressed that a figure still has to be determined, but a "reduction by 50 per cent would be wonderful."

MRSA can hide inside a nostril, on a hand or in soiled clothing. Symptoms can vary from a blotch of reddened skin treatable with a topical antibiotic to a merciless attack that causes blood poisoning, decayed lungs, pneumonia and infected heart valves.

The superbug has made significant inroads in Canada, where the rate of those colonized and infected over the past decade has increased tenfold. Some of the highest rates have been noted in Quebec and Ontario, according to the Canadian Nosocomial Infection Surveillance Program study, which looked at MRSA in 38 hospitals in nine provinces.

Ontario, for example, is something of an MRSA hot spot: 13,458 patients were found to be colonized or infected with it in 2006, the highest number the province has ever recorded, according to the most recent figures from Ontario's Quality Management Program - Laboratory Services.

The scourge of hospital-acquired infections have been the subject of marketing campaigns, buttons and posters, most of them aimed at encouraging health-care workers, patients and visitors to hospitals to wash their hands.

MRSA

What is MRSA? Methicillin-resistant Staphylococcus aureus is a bacterial infection resistant to the antibiotic methicillin.

Who is at risk? Hospital patients, the elderly, the very ill and frequent or long-term users of antibiotics run a greater risk of acquiring it.

How is MRSA spread? It is usually spread through hand contact. The hands of health-care workers can become contaminated by contact with patients, or the bug may cling to surfaces in hospitals and medical devices.

What are the symptoms? MRSA generally starts as small red bumps that resemble pimples, boils or spider bites. These can quickly turn into deep, painful abscesses that require surgical draining. Sometimes the bacteria remain confined to the skin but they can also burrow deep into the body, causing potentially life-threatening infections in bones, joints, surgical wounds, the bloodstream, heart valves and lungs.Other superbugs

Vancomycin-resistant enterococci: Enterococci are bacteria that live in the bowels of most people. VRE is a strain that has developed resistance to many commonly used antibiotics, specifically vancomycin.

C. difficile: Clostridium difficile is a bacterium that causes severe diarrhea.

By Lisa Priest, Toronto Globe and Mail

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Conquering AIDS — If We Have A HAART

February 7, 2008


Dr. Julio Montaner: more aggressive AIDS treatment needed for those in helpless situations. 
photo by Brian Smith

One of the world’s leading researchers in HIV/AIDS, Dr. Julio Montaner, believes it is possible to completely eliminate the transmission of HIV in Canada, starting in British Columbia.

"We have come a long way in two decades of treating HIV/AIDS," says Montaner, Director of the BC Centre for Excellence in HIV/AIDS. "I really believe by expanding HAART (highly active anti-retroviral therapy), a therapy proven to work, we can finally control this epidemic."

There are 12,000 people in British Columbia who are HIV positive. The B.C. Centre for Excellence in HIV/AIDS estimates that 2,000 are not receiving treatment even though most have access to free therapy.

HAART treats HIV with a combination of drugs (anti-retrovirals) that blocks HIV replication at different stages of its life cycle. As a result, HAART dramatically reduces the amount of HIV in the blood, known as viral load, and this in turn helps to decrease the risk of HIV transmission.

"We have proven that among those who engage in care, 90 per cent show a vast improvement and transmission almost disappears," says Montaner. "But this benefit is restricted to those who initiate and adhere to HAART treatment."

The benefits of HAART are major and long lasting – life expectancy increases and quality of life improves. Further, transmission is greatly reduced. This means that HIV-infected women can give birth without transmitting the virus to their babies, as long as they are on HAART.

"The reality for the more vulnerable members of our community is that seeking treatment for HIV does not rank high enough to make it a priority," says Montaner. "This creates completely unnecessary pain and suffering for people and generates futile health care expenses."

Most Canadians, if given a HIV-positive verdict, would seek treatment without delay. This is not the case, however, for many people who are homeless, mentally ill, substance abusers or all of the above.

Montaner believes that it’s possible to improve the situation. He believes that it requires rethinking the current passive approach to treatment and creating a more aggressive method of providing care for HIV sufferers in helpless situations. Montaner calls this approach "seek and treat."

"It is not unlike what we did for tuberculosis in the past," says Montaner. "We need to go out there, find the cases, and engage them in comprehensive education, prevention and care programs. We need a dynamic outreach program that will allow us to find, through trial and error, effective ways to engage these hard to reach populations in care. Only then we will be able to stop HIV in BC."

As Professor of Medicine and Chair of the AIDS Research Division at UBC and also President-Elect of the International AIDS Society, Dr. Montaner has worked on treating HIV/AIDS since 1981.

He was the lead investigator of a seminal clinical trial that demonstrated that non-nucleoside reverse transcriptase inhibitor (NNRTI) – based HAART could render HIV plasma levels undetectable and lead to full remission of the disease. Montaner unveiled this groundbreaking research at the International AIDS Conference held in Vancouver in 1996.

"Clearly HIV is readily preventable," says Montaner. Still, HIV/AIDS is ranked fourth on the Top 20 Causes of Death Worldwide list created by the World Health Organization. Traditional prevention strategies (including safer sex, harm reduction, etc) are the number one priority. But when prevention fails, treatment can be lifesaving. HAART treatment of those in medical need is the next priority.

"When HAART was introduced as a treatment, the incidence of HIV was reduced by 50 per cent. But since 1998 these figures have reached a plateau," explains Montaner. "When you put all the facts together a new model for prevention and treatment is required."

By Julie-Ann Backhouse, www.UBC.ca

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AIDS Advocates Call For Support As Epidemic Grows In Aboriginal Communities

February 8, 2008

As the number of aboriginal people living with HIV and AIDS in Canada grows, efforts to address the situation should consider the social factors, such as poverty, behind the epidemic, advocates say.

But for much-needed progress to be made, the stigma and discrimination borne by aboriginal people with AIDS must end, according to the Canadian Aboriginal AIDS Network. That’s why the network is calling on First Nations, Métis, and Inuit leaders ahead of Valentine’s Day, and asking them to speak out on the issue in public.

"A lot of us take it for granted. If we’re healthy and living with friends and family and loved ones around us, we think that everything’s all right in the world," Kevin Barlow, the network’s executive director, told the Georgia Straight by phone from Ottawa. "In reality a lot of aboriginal people who are living with HIV and AIDS talk about the isolation and the rejection they experience."

Hearing leaders denounce discrimination and then endorse AIDS prevention, harm-reduction, and treatment programs, he said, will help create more supportive environments in aboriginal communities and encourage those at risk of or living with human immunodeficiency virus or acquired immune deficiency syndrome to get tested or seek assistance.

"When the awareness level is low, then you have higher levels of stigma and discrimination," Barlow said. "When you can inform and educate people, then you bring the stigma and discrimination levels down a bit, because people are more informed and they’re not afraid."

Statistics show aboriginal people—who compose 3.8 percent of Canada’s population, according to the 2006 census—are overrepresented among cases of HIV and AIDS in Canada, and the percentages continue to rise.

According to statistics published by the Public Health Agency of Canada, aboriginal persons made up 3.1 percent of reported AIDS cases with information on ethnicity from 1979 to 2003, and 23.4 percent of positive HIV-test reports from 1998 to 2003. In 2003, 13.4 percent of reported AIDS cases involved aboriginal persons, up from 1.2 percent before 1993. Aboriginal persons composed 25.3 percent of positive HIV-test reports in 2003, up from 18.8 percent in 1998.

Women and youth are also disproportionately represented among new infections in the aboriginal population, compared to the non-aboriginal population.

"Infection rates are far worse here amongst aboriginal people than they are among some Third World developing countries," Shawn Atleo, regional chief of the British Columbia Assembly of First Nations, told the Straight. "This should be a general public concern, not just an aboriginal-health issue."

Atleo said he’s willing to speak publicly to fight the stigma and discrimination that still surround AIDS and to support the work of people in the field.

"This is very personal, I think, for everyone in our community. You don’t have to go far," he said. "I lost one of my childhood friends to the disease, from Ahousaht, west coast of Vancouver Island—not on the Downtown Eastside. This is in our communities everywhere.

Ken Clement, president of the Canadian Aboriginal AIDS Network and executive director of the Vancouver-based Healing Our Spirit BC Aboriginal HIV/AIDS Society, said financial, human, and technical resources are needed in communities across the province to support aboriginal people living with the disease. Indeed, he said, the lack of resources in rural communities can lead people with AIDS to seek out services in Vancouver.

"If we don’t have those resources I talked about, it’s almost pointless to speak of our future as a nation if we don’t have the people," Clement said. "It’s kind of ironical that we talk about treaty process, but if we have our communities infected and affected by HIV and other health issues, then it seems to be a lost cause."

Both Barlow and Clement maintained social factors—such as poverty, lack of education and housing, foster care, and residential-school wounds—are driving the AIDS epidemic in aboriginal communities.

"When people are below poverty levels and they can’t get gainful employment and they’re struggling with mental-health challenges or these childhood wounds that come from things that they have no control over, it creates a very different dynamic for people," Barlow said.

Dirty needles are responsible for most new HIV infections among aboriginal people, he noted, adding that means there is much harm-reduction work to be done.

A study by the B.C. Centre for Excellence in HIV/AIDS, to be published in the March issue of the American Journal of Public Health, found aboriginal people in Vancouver who inject drugs are much more likely to have or to be infected with HIV than non-aboriginal injection-drug users.

Entering the study period, 25.1 percent of aboriginal participants were HIV-positive, compared to 16 percent of non-aboriginal subjects. Four years later, 18.5 percent of aboriginal participants reported new HIV infections, while only 9.5 percent of non-aboriginal persons did.

"Our findings demand a culturally appropriate and evidence-based response to the HIV epidemic among Aboriginal injection drug users," the study’s authors wrote, according to a draft.

By Stephen Hui , http://www.straight.com

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Fair Play Or Morality Play?

February 9, 2008

London, Ontario - Barry Mann has been HIV-positive for 19 years and practises safe sex.

He learned to take precautions after watching many friends die of AIDS in the 1980s.

Now, at 53, he's scared -- not of infecting his sexual partners with the virus that causes AIDS, but of being accused of infecting them -- and going to jail.

"To date, I haven't had somebody who's out to get me," he says.

A recent criminal case in London -- one of four HIV-related cases before the courts here and one in St. Thomas -- has left Mann with an uneasy feeling the criminal courts are judging HIV-related cases on the basis of morality, not public protection.

Ryan Handy, 25, a young gay man with mental illness, was convicted last month of aggravated sexual assault. He testified that at one time he believed he had sweated out his HIV and was the Messiah.

After two unprotected sexual encounters with a 53-year-old man he met in an Internet chat room, Handy testified, he had a moment of clarity, realized he had the virus and immediately contacted the man and told him he was HIV-positive. His lack of disclosure of his HIV status required by law could send Handy to prison when he's sentenced next month.

There is a debate brewing -- and an opinion in the gay community -- that the victim in the case, who has remained virus-free, should have taken care of his own sexual health while engaging in high-risk sexual behaviour and not be accusing a young, vulnerable man of a criminal act.

Mann says the courts should stay out of people's bedrooms when it comes to disclosing HIV.

"It should not be tying up the courts," he says. "It's a health issue, not a criminal issue."

Breakthroughs in treatment have allowed Mann and many other HIV-positive people to live with the virus for decades. He's still legally obligated to tell his sexual partners he has the virus, something he admits doesn't always happen because he uses protection.

"I am constantly floored by how many people are willing to have sex with me without taking precautions. I'm the one who has to stop them," he says. "Society is still very nonchalant about this."

It's been 15 years since the death of Charles Ssenyonga, a man with a virulent strain of AIDS who was being tried for knowingly spreading the virus to several women -- some of whom died -- in London. He died just weeks before Superior Court Justice Dougald McDermid was to deliver a decision.

Half a generation later, there are suggestions it's time for HIV to be taken out of the Criminal Code.

There have only been 29 HIV-related cases in Canada and six are before the courts. It appears the majority on trial now are in the London area. All the current London cases involve men -- two straight and two gay -- said not to have disclosed their HIV status to sexual partners.

In the cases of people maliciously spreading the virus, there's a unified opinion inside and outside the criminal justice system those cases need to be tried criminally.

But in the Handy case, and in the Mark Hinton case that was dismissed this week, the facts involved allegations of consensual sex between people engaged in high risk activities. (Hinton, 41, who has been HIV-positive for 22 years, faced a charge of attempted aggravated sexual assault. A judge dismissed the charge).

Those cases, some activists say, could have best been handled by public health -- not the criminal justice system that they say seems to judge morality and not promote public protection.

"If you take the HIV out of there, it's still a crime," says Peter Hayes, executive director of the AIDS Committee of London, about HIV cases involving sexual assault and intentional spread of the disease.

But, he says, "when we make it about HIV-only, the law can be misinterpreted, or situations are not being addressed in the best interests of public health."

Hayes says cases like Handy's and others go to the most intimate piece of a relationship and solidify the stigma attached to disease that has gone from a death sentence to an often controllable condition.

Prosecution of such cases leaves the community with a false sense of security, he says. The reality, he says, is that the vast majority of HIV-positive people disclose their status not just to their partners, but to family, employers, doctors and anyone they believe could be at risk.

The majority of new transmissions are in the straight community and come from people who haven't been tested.

Brian Lester, director of prevention for the agency, says the best strategy to stop the transmission of the virus is to encourage testing and help people make informed decisions about their results. But criminalization "challenges that, he says.

"People don't want to deal with what could be a reality in their life," he says, and won't get the test. "A fully informed individual making a choice not to use a condom is putting themselves at risk."

Hayes says he's concerned there's not enough education in, and outside of, the criminal justice system about the virus and the disease.

He points to a 2003 study across Canada that showed people were less informed about HIV and AIDS than ever, with beliefs that only gay men and drug users and people living in Africa were at risk.

"Issues surrounding sex and drugs are being talked in a way that's not about health but more about morality," he says.

Lester says the health system has the tools to handle the cases.

Already, public health can issue orders that outline rules an HIV-positive person must follow, such as using condoms in all sexual encounters and not sharing needles. It also has the power to detain people, Lester says.

He adds the justice system adds to the stigma when prosecuting these cases as aggravated sexual assaults.

"I don't understand the term sexual assault in consensual sex," he says.


Even the failure to disclose during pillow talk needs to be prosecuted, some in legal circles say.

A London lawyer who successfully defended Hinton agrees HIV cases should be judged in criminal courts.

"It should absolutely be an offence," says Ron Ellis. "Because you can't consent to having sexual relations with someone if the act is so manifestly different than what you expected it was going to be.

"HIV changes the very nature and character of the sex you are consenting to such a degree."

HIV still remains potentially life-threatening, he says, and although not necessarily a death sentence, it requires a lifetime of treatment and medications. It restricts freedoms and choice of sexual partners.

"It's got to be worth something," Ellis says.

If Hinton had been found guilty, Ellis notes, he would have faced a prison sentence of three to six years.

"I think its a crime to put somebody at risk," Ellis says. "The law is you've got to disclose and it's a good law. It's there for the health and safety of the community."

Dr. Bryna Warshawsky, associate medical officer of health for the Middlesex-London Health Unit, says the spread of the virus is "certainly a health issue," and adds it's "very rare and unusual for people with HIV not to be responsible."

The Ryan Handy case has become a rallying point for some in the gay community -- a group of supporters was with him at his sentencing hearing last month.

Handy can be seen in a three-part interview on the Xtra magazine website denouncing what he calls unfair treatment by the criminal courts.

An editorial by managing editor Matt Mills in the gay magazine criticizing the victim in December prompted the victim in the Handy case to not submit a victim impact statement.

Mills says he thinks "it's really important that folks who are in the position he is in have the opportunity to tell their stories." He says his publication believes some men, particularly gay men, get "the short end of the stick on this legislation and these sentencing guidelines.

"We believe the criminal justice system is singularly unqualified and ill-equipped to handle this issue."

The Supreme Court of Canada, Mills says, in its decision that HIV-positive people have a duty to disclose their illness before having unprotected sex, "has put us in a position we are at each other's throat and suspicious of each other when it is a public health matter."

Mann, who also recently completed treatment for Hepatitis C, agrees.

"Nobody forced their pants down. Nobody forced them to have sex. Everybody's responsibility is to protect themselves."

He fears that whether he discloses his health status or not in the bedroom becomes hearsay in a courtroom.

"I can disclose to somebody and they can turn around and say I didn't disclose," he says, adding he fears the issue could evolve into civil cases in which former lovers are pitted against each other.

"We're already dealing with living with this disease and the stigma attached. We don't need this on top of it."

HIV And The Law

The Supreme Court of Canada ruled in 1998 that:

- HIV-positive people must disclose their status to sexual partners before having sex without a condom or sharing sex toys.

- They must tell people with whom they share drug equipment before sharing the equipment.

- Non-disclosure could lead to an order by a local public health unit that would outline rules that must be followed and could include using a condom in all sexual encounters or no sharing of needles.

- Criminal Code charges can be laid by a sexual- or needle-sharing partner. The charges range from common nuisance to aggravated sexual assault. Charges can be laid even if the partner is not infected.

Cases Before The Courts

- Edward Kelly, 31, was charged with aggravated sexual assault in May 2006, after a woman told police she had sex with a man who didn't tell her he was HIV-positive. He is next in Superior Court on Feb. 12.

- Tendai Mazambani, 33, was charged with four counts of aggravated sexual assault in October 2006. He is expected to set a date for an Ontario Court preliminary hearing.

- The case against Mark Hinton, 41, was dismissed this week after his complainant admitted HIV status was not a concern to him before engaging in "moderately high risk" sexual activities. Hinton, who didn't get the chance to testify, maintained he never had sex with the man.

- Ryan Handy, 25, a gay man who testified he is mentally ill and believed he sweated out his HIV, is to be sentenced for aggravated sexual assault March 27.

- Owen Antoine, 41, of Aylmer was convicted by a jury in St. Thomas this month of four charges, including aggravated sexual assault and criminal negligence causing bodily harm. Antoine was diagnosed HIV-positive in December 2004. The victim, a 29-year-old woman, testified she was at a bar with Antoine in April 2006 and has no memory after she drank a shooter he said he took to her. She woke up hours later in bed with him and he told her they had unprotected sex. She has since tested positive for HIV. Antoine did not tell her he had the virus.
 
By Jane Sims, http://lfpress.ca

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Liberal Leader Dion Indicates Vancouver Safe Injection Site Is OK

February 8, 2008

Vancouver - The Liberal party has no intention of advocating the legalization of cannabis but leader Stephane Dion made it clear Friday that under a Liberal government, other Canadian cities could see safe injection sites like the one in Vancouver.

Dion, whose party could be embroiled in an election campaign this spring, took about 20 questions at a "town hall meeting" at the University of British Columbia.

The questions were wide-ranging and included the Liberal party's position on Afghanistan, the economy, climate change - and marijuana.

"It's not something we will campaign on in the next election," Dion said candidly. "But we need to have an approach about drugs that is more effective than the one the government has to date."

Without being asked about it, he told the crowd of about 150 students that Canada's only safe injection site - known as Insite and situated in the Downtown Eastside - "is something in which we believe.

"I think the current government has an ideological approach about that," Dion told the gathering that was co-ordinated by the Young Liberals of UBC.

"If the science is telling you that an initiative like that is saving lives, we need to continue it."

The Harper government has said that the city's safe injection site can remain open until June.

Health Canada announced in October it would extend the exemption from Canada's drug laws that allows Insite to operate. The exemption was set to run out at the end of the year.

The site provides a place for addicts to safely inject themselves with their own heroin under the supervision of medical staff.

A spokeswoman for Health Canada said the exemption will allow further research.

Dion added that a Liberal government would investigate if there are other communities in Canada "willing to address the problem this way."

Another student suggested that Canada often kowtows to the U.S. on many issues and wanted to know how Dion would deal with the U.S. administration.

"If you get into power, how are you going to handle the way Canada kind of lies down when they want us to do something but then when we want them to do something they kind of slough us off, right?" the student asked.

"For us Canadians, the United States is a friend," said Dion.

"It is an ally but it is not a model," he said to loud applause. "This difference between a friend and a model is not well understood by the current prime minister and it will be by me."

He also told the students that Canada must have its "economic sovereignty protected."

But as a trading nation with the U.S., he said Canada's "balance of trade is very advantageous for Canada.

"Our trade with the U.S. must be effective but it must be open as well because we are making a lot of money trading with them.
 
The Canadian Press

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International News

House GOP Opposes AIDS Program Changes

February 8, 2008

Washington - House Republican leader John Boehner and other Republicans warn that a successful program to combat AIDS in Africa would be in jeopardy if Democrats move ahead with plans to make changes.

Boehner, R-Ohio, said the Democratic proposal to renew the five-year, $15 billion anti-AIDS effort "will undermine this valuable program as we know it, placing at risk the work it does on behalf of millions."

In what is shaping up to be a political and ideological showdown, House Foreign Affairs Committee Chairman Tom Lantos, D-Calif., replied that his Democratic proposal reaffirmed the compromise he worked out with the late Rep. Henry Hyde, R-Ill., in 2003. It is a shame, he said, that the GOP minority is "failing to honor this spirit of compromise and is willing to endanger a valuable U.S. foreign policy program addressing one of the most serious health care challenges that humanity faces today."

The program expires this year and President Bush, who travels to Africa this month, has urged Congress to double funding to $30 billion over the next five years. The President's Emergency Plan for AIDS Relief is now treating 1.4 million people, with the focus on 15 mostly sub-Saharan African nations.

Democrats, backed by AIDS groups, say that's still not enough to cope with the continuing HIV/AIDS crisis, and Lantos' committee next Thursday is to vote on a bill approving $50 billion in funds and making several changes that have enraged social conservatives.

The Lantos bill would eliminate a provision in the 2003 bill requiring that one-third of all prevention spending go to abstinence programs. That amounts to about 7 percent of all spending. Critics say that while they don't oppose abstinence programs, inflexible funding requirements are counterproductive.

It also would remove a provision stating that all groups receiving money under the program must sign a pledge confirming that they do not support the legalization of prostitution or sex trafficking. The groups still may provide condoms or condom information to prostitutes. The provision, said its author, Rep. Chris Smith, R-N.J., was designed to "ensure that pimps and brothel owners don't become U.S. government partners."

Democrats said studies have shown that some groups will not or cannot make the pledge because of concerns it will alienate women they are trying to reach. Other groups say legalized and controlled prostitution could help slow the spread of HIV infection.

Third, Republicans claimed that the Democratic-written bill undoes carefully crafted rules that allow money to go to family planning groups for AIDS work as long as no money is spent on abortions. That change, Rep. Mike Pence, R-Ind., said at a news conference including anti-abortion groups, "would transform the program into a mega-funding pool for organizations with an abortion promotion agenda."

Lantos said the administration has endorsed a link between family planning and HIV/AIDS programs, and that his bill clarifies that additional contraceptive services may be provided under the law as long as these services are focused on stopping the transmission of HIV/AIDS.

His spokesman, Lynne Weil, said it is clear that funds are not available for abortion and it strengthens the "conscience clause" that allows faith-based groups to opt out of any program to which they have a moral objection.

By The Associated Press, www.365Gay.com 

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Alleged Rape Victim Is HIV Positive

February 6, 2008

A court at the Old Bailey has been told that a 26-year-old man who accused a BBC Radio 4 reporter of raping him is HIV positive.

Nigel Wrench, 47, was open about his status and had made a documentary, Aids and Me about his experiences living with HIV and a later diagnosis of AIDS.

He is accused of drugging and sexually assaulting the 26-year-old after inviting him back to his flat in north London after meeting him at a New Years party.

Mr Wrench's defence barrister, Sarah Forshaw QC, told the court that the alleged victim did not mention his HIV status.

Constance Briscoe for the Crown Prosecution Service had earlier told the court:

"In order to get his way with the victim, he drugged him and he raped him and he sexually assaulted him.

The jury were told that he suffered from "flashes of darkness" and "periods of blackness," before finding himself naked on the Mr Wrench's bed as the radio reporter put a pill into his mouth.

Mr Wrench faces accusations of rape, sexual assault, together with administering the sleeping tablet, Temazepam, with the intention of overpowering his victim in order to have sexual intercourse on the 1st January 2007.

He denies all charges. The trial continues.

PinkNews.co.uk

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HIV Infections Up 20% In Sweden

February 6, 2008

500 people were newly diagnosed as HIV positive in Sweden in 2007 according to data published by the Swedish Institute for Infectious Disease Control (SMI).

That number represents a rise of 20% on 2006.

There has been a 70% rise in the number of people infected within Sweden, though the majority of new HIV patients still come into contact with the virus abroad.

"We have especially seen an increase in the number of new infections among men who have sex with men and needle-users," SMI statistician Malin Arneborn told AFP.

MSM infections rose from 50 cases in 2006 to 80 in 2007.

"Interest in HIV/AIDS has gradually declined as people have become more accustomed to the threat," Claes Herlitz, an expert in Swedish attitudes to HIV, told AFP.

"They've seen that HIV hasn't spread as quickly as we thought it would in the late 80s, and there are new medicines making it more difficult to get AIDS. Fewer people are dying."

In the UK the Health Protection Agency revealed in November that the number of gay and bisexual men diagnosed with HIV in the UK is at its highest rate since the start of the epidemic.

2,700 gay and bisexual men were newly diagnosed last year, the highest number ever.

Across the UK 1 in 20 gay and bisexual men are now living with HIV and estimates suggest this figure is as high as 1 in 10 in London.

Furthermore, nearly half (47 per cent) of HIV infected gay men who visit a sexual health clinic leave without being tested for HIV.

Overall diagnoses in the UK remain high.

7,800 people were diagnosed last year, and the numbers living with HIV in the UK were 73,000 by the end of 2006.

One in three people do not know they are infected.

If rates continue the National AIDS Trust says that by 2010 there will be 100,000 people living with HIV in the UK.

The report also reveals worrying findings among young people with 1 in 10 (11 per cent) new diagnoses last year among 16 to 24 years old.

PinkNews.co.uk

[ Top ]

African Women Slam Abuse of Females With HIV/AIDS

February 4, 2008

Ouagadougou - Hundreds of sub-Saharan Africans rallied Monday in Burkina Faso against the abuse of women infected with HIV/AIDS.

"There is no doubt that lots of human rights violations characterise the (HIV/AIDS) pandemic," said Bernice Heloo, president of the Society for Women and AIDS in Africa (SWAA).

"Women are the ones who most severely bear brunt of human rights abuse, have been prone to violences and other atrocities related to their gender and seropositive status.

"Many women have been driven from their marital homes, stripped of their hard-earned possessions and separated from their children and people they love," she told a conference attended by Burkina Faso Prime Minister Tertius Zongo.

She urged the international community to lend their technical and financial support to "strengthen the battle against gender inequality in Africa, a key factor in the spread of the pandemic and to contribute to the promotion of human rights for people living with and affected by HIV/AIDS."

Around 500 women from some 30 sub-Saharan countries are taking part in the four-day meeting debating violence against women and HIV/AIDS, their rights and access to treatment.

Although sub-Saharan Africa is home to just over 10 percent of the world's population, it is the most ravaged by HIV, carrying more than 60 percent of all people living with the virus that causes AIDS.

The conference has been organised by SWAA and its branch in Burkina Faso with the help of UNAIDS, the Burkina Faso government and a host of anti-AIDS non-governmental organisations.

AFP

[ Top ]

Egypt: Stop Criminalizing HIV

February 5, 2008

New York - A series of arrests in Cairo sparked by one man's admission to police that he was HIV-positive endangers public health as well as human rights, Human Rights Watch said today. Human Rights Watch called on Egyptian authorities to overturn the convictions of four men for the "habitual practice of debauchery," and to free four others who are held pending trial. The government should end arbitrary arrests based on HIV status and take steps to end prejudice and misinformation about HIV/AIDS.

"These shocking arrests and trials embody both ignorance and injustice," said Scott Long, director of the Lesbian, Gay, Bisexual, and Transgender Rights Program at Human Rights Watch. "Egypt threatens not just its international reputation but its own population if it responds to the HIV/AIDS epidemic with prison terms instead of prevention and care."

The arrests began in October 2007, when police stopped two men having an altercation on a street in central Cairo. When one of them told the officers that he was HIV-positive, police immediately took them both to the Morality Police office and opened an investigation against them for homosexual conduct. The two men told human rights defenders that they were slapped and beaten for refusing to sign statements the police wrote for them. They spent four days in the Morality Police office handcuffed to an iron desk, sleeping on the floor. Police later subjected the two men to forensic anal examinations designed to "prove" that they had engaged in homosexual conduct.

Human Rights Watch has documented that such examinations to detect "evidence" of homosexuality are not only medically spurious but constitute torture.

Police then arrested two more men because their photographs or telephone numbers were found on the first two detainees. Authorities subjected all to HIV tests without their consent. All four are still in detention, pending prosecutors' decision on whether to bring charges of homosexual conduct. The first two arrestees, who reportedly tested HIV-positive, are being held in a Cairo hospital, handcuffed to their beds and only unchained for an hour each day.

Meanwhile, police apparently placed the apartment where one of the men had lived under surveillance. On November 20, two days after a new tenant had assumed the lease, police raided the apartment and detained four other men.

According to the arrest report, the men were fully dressed and were not engaging in any illegal acts at the time of the arrests. However, all were charged with homosexual conduct, apparently solely on the basis that they were found in a dwelling formerly occupied by one of the earlier detainees.

People who have spoken to the four men since their arrest told Human Rights Watch that a non-commissioned officer in the police station beat one detainee on the head several times. Police allegedly forced the four men to stand in a painful position for three hours with their arms lifted in the air. They were provided no food, drink, or blankets during their first four days of detention. Authorities also tested these men for HIV without their consent. One of the men reportedly said that the prosecutor, when informing him that he had tested positive for HIV, told him: "People like you should be burnt alive. You do not deserve to live."

A Cairo court convicted these four men on January 13, 2008 under Article 9(c) of Law 10/1961, which criminalizes the "habitual practice of debauchery [fujur] a term used to penalize consensual homosexual conduct in Egyptian law. According to defense attorneys, the prosecution based their case only on coerced and repudiated statements taken from the men, and neither called witnesses nor produced other evidence to counter the men's pleas of not guilty. On February 2, 2008, a Cairo appeals court upheld their one-year prison sentence. One of them is held in a Cairo hospital, chained to his bed 23 hours a day.

"These cases show Egyptian police acting on the dangerous belief that HIV is not a condition to be treated but a crime to be punished," said Long. "HIV tests forcibly taken without consent, ill-treatment in detention, trials driven by prejudice, and convictions without evidence all violate international law."

In private letters sent to the Egyptian Public Prosecutor, Counselor Abdel Meguid Mahmoud Abdel Meguid, on November 29, 2007 and on January 8, 2008, Human Rights Watch expressed its grave concern about the arrests and their consequences for Egypt's efforts against HIV/AIDS.

Human Rights Watch urged authorities to drop the charges, end the practice of chaining detainees in hospital, and ensure that the men receive the highest available standard of medical care for any serious health conditions. It also urged Egypt to undertake training for all criminal-justice officials on medical facts and international human rights standards in relation to HIV, and to halt immediately all testing of detainees without their consent.

Criminalizing consensual, adult homosexual conduct violates human rights protections to individual privacy and personal autonomy under international law. The apparent use of Article 9(c) in these cases to detain people on the basis of their declared HIV status, and to test them without their consent for HIV infection, also violates those international protections, and the right to bodily autonomy.

International human rights law clearly affirms that prisoners and detainees retain the absolute right to protection against torture and cruel, inhuman, or degrading treatment or punishment and enjoy the right to the highest attainable standard of health, as guaranteed in Article 12 of the International Covenant on Economic, Social and Cultural Rights, to which Egypt has been party since 1982.

Human Rights Watch, Reuters

[ Top ]
Studies & Treatment News

Scientists Find New Receptor for HIV

February 11, 2008

San Francisco - Government scientists have discovered a new way that HIV attacks human cells, an advance that could provide fresh avenues for the development of additional therapies to stop AIDS, they reported on Sunday.

The discovery is the identification of a new human receptor for HIV The receptor helps guide the virus to the gut after it gains entry to the body, where it begins its relentless attack on the immune system.

The findings were reported online Sunday in the journal Nature Immunology by a team headed by Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

For years, scientists have known that HIV rapidly invades the lymph nodes and lymph tissues that are abundant throughout the gut, or intestines. The gut becomes the prime site for replication of HIV, and the virus then goes on to deplete the lymph tissue of the key CD4 HIV-fighting immune cells.

That situation occurs in all HIV-infected individuals, whether they acquired the virus through sexual intercourse, blood transfusions, blood contamination of needles and syringes, or in passage through the birth canal or drinking breast milk.

The findings appear to provide some, if not the main, answers to how and why that situation occurs.

Dr. Warner C. Greene, an AIDS expert and the director of the Gladstone Institute of Virology and Immunology here who was not involved in the research, said the findings were "an important advance in the field."

"They begin to shed light on the mysterious process on why the virus preferentially grows in the gut," Dr. Greene said in an interview.

Dr. Fauci, James Arthos, Claudia Cicala, Elena Martinelli and their colleagues showed that a molecule, integrin alpha-4 beta-7, which naturally directs immune cells to the gut, is also a receptor for HIV A protein on the virus’s envelope, or outer shell, sticks to a molecule in the receptor that is linked specifically to the way CD4 cells home in on the gut, the researchers said.

Binding of the virus to the integrin alpha-4 beta 7 molecule stimulates activation of another molecule, LFA-1, which plays a crucial role in the spread of the virus from one cell to another. The actions ultimately lead to destruction of lymph tissue, particularly in the gut.

Several other receptor sites for HIV are known. The most important is the CD4 molecule on certain immune cells; the molecule’s role as an HIV receptor was identified in 1984.

Two other important receptors, known as CCR5 and CXCR4, were identified in 1996. CCR5 is a normal component of human cells and acts as a doorway for the entry of HIV People who lack it because of a genetic mutation rarely become infected even if they have been exposed to HIV repeatedly.

"The work we did took nearly two years, and there’s little doubt that what we have found is a new receptor," Dr. Fauci said in an interview after giving a lecture here, adding that "we certainly have to learn a lot more about it."

Scientists have sought to identify receptors because they offer targets for the development of new classes of drugs.

For example, last year the Food and Drug Administration approved for AIDS treatment a Pfizer drug, Selzentry or maraviroc, which works by blocking CCR5.

Dr. Fauci said he hoped his team’s findings would encourage other scientists from different disciplines to explore new ways to attack HIV

A number of experimental drugs that block the integrin alpha-4 beta-7 receptor are being tested for the treatment of autoimmune disorders. Dr. Fauci said such drugs should also be studied for their potential benefit in AIDS treatment.

Organization of new trials in the next year or so could test such drugs in animals and humans to determine their safety and effectiveness against HIV, Dr. Fauci said.

One candidate is a drug, Tysabri or natalizumab, that is marketed for treatment of multiple sclerosis, Dr. Fauci said. Biogen/Elan makes Tysabri.

If trials for HIV are successful, Dr. Fauci said, the drugs could be added to existing treatment regimens.

By Lawrence K. Altman, The New York Times

[ Top ]

Probiotics May Ease Gut Problems In People With HIV/AIDS

February 4, 2008

Probiotic supplements may ease the suffering from diarrhoea and nausea amongst people with HIV and AIDS, suggests a joint study by African and Canadian researchers.

The occurrence of diarrhoea was stopped by taking the gut-friendly bacteria among 24 people with HIV/AIDS in the sub-Saharan region of Africa, a population where many suffer from debilitating effects of diarrhoea, and only a few have access to antiretroviral therapy, reports the new study.

"This is the first study to show the benefits of probiotic yogurt on quality of life of women in Nigeria with HIV/AIDS, and suggests that perhaps a simple fermented food can provide some relief in the management of the AIDS epidemic in Africa," wrote lead author Kingsley Anukam in the Journal of Clinical Gastroenterology.

The researchers, from the University of Benin, Benson Idahosa University, and the Canadian Research and Development Centre for Probiotics at the University of Western Ontario, recruited 24 women with HIV/AIDS aged between 18 and 44 and with clinical signs of moderate diarrhoea, and assigned them to receive a normal or probiotic yoghurt (100 mL) for 15 days.

"Given the track record of probiotics to alleviate diarrhoea, conventional yogurt fermented with Lactobacillus delbruekii var bulgaricus and Streptococcus thermophilus was supplemented with probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14," explained the researchers.

The women were not receiving antiretroviral therapy or dietary supplements, and the average CD4 T-lymphocyte count (the immune system cells that the virus attacks) was over 200.

At the end of intervention period, Anukam and co-workers report that the occurrence of diarrhoea, flatulence, and nausea was resolved in all 12 subjects receiving the probiotic yoghurt, compared to only two out of the 12 in the normal (control) yoghurt.

Moreover, the average CD4 count remained the same in 92 per cent (11 out of 12 people) of the subjects in the probiotic group, while the level only remained the same in 25 per cent (three out of 12 people) receiving the control yoghurt.

White blood cells counts of the probiotic-supplemented group were 5.8 billion cells per litre at the start, and 6.0 billion cells per litre after 15 days. The level decreased slightly to 5.4 billion cells per litre 15 days after the supplementation period stopped.

The study, although small and short, suggests probiotics could play a role in improving the quality of life of people with HIV/AIDS, particularly in areas where diarrhoea is a debilitating condition.

A report published by the World Health Organisation in November 2005 showed that the number of people living with HIV was at its highest ever: 40.3 million. More than 3 million people died of AIDS-related illnesses in 2005, with more than 500,000 of these children.

Previously, researchers have reported that probiotic supplements (Lactobacillus rhamnosus GG) may provide added protection against gastro-intestinal infection and diarrhoea in infants. The study, published in the open access journal BMC Microbiology, was conducted in animals and showed that 59 per cent of animal subjects did not develop rotaviral diarrhoea when the probiotic was administered before infection with rotavirus.

Source: Journal of Clinical Gastroenterology
Publihsed online ahead of print, January 2008, doi: 10.1097/MCG.0b013e31802c7465
"Yogurt Containing Probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 Helps Resolve Moderate Diarrhea and Increases CD4 Count in HIV/AIDS Patients"
Authors: Kingsley C. Anukam, E.O. Osazuwa, H.B. Osadolor, A.W. Bruce, G. Reid

By Stephen Daniells, http://www.foodnavigator.com

[ Top ]

HIV Drugs Make Breast-Feeding Safer, Study Finds

February 4, 2008

Washington - A drug that helps prevent babies from catching the AIDS virus at birth can also protect them while nursing, researchers reported on Monday.

Babies of HIV-infected women who were given the drug nevirapine while they breast-fed were half as likely to become infected, the researchers told a meeting in Boston of AIDS experts.

Nevirapine is already widely used to protect babies at birth. A single dose given to the mother as she goes into labor and to the baby at birth cuts transmission by 47 percent.

But babies continue to become infected after birth, via their mothers' breast milk, which can carry the virus. In many developing countries breast-feeding is the only option.

Dr. Brooks Jackson of Johns Hopkins University in Baltimore and colleagues in Ethiopia, India and Uganda wanted to see if they could safely continue giving the drug to babies for as long as six weeks.

They gave 2,000 new babies either nevirapine or a vitamin solution between 2001 and 2007.

"At 6 months of age, the risk of postnatal HIV infection or death in infants who received the six-week regimen was almost one-third less than the risk for infants given only a single dose," Johns Hopkins said in a statement.

The World Health Organization estimates that 150,000 infants are infected with the AIDS through breast-feeding each year. The fatal and incurable virus infects 33 million people globally.

Nevirapine is sold under the brand name Viramune by privately held Boehringer Ingelheim.

By Maggie Fox, editing by Will Dunham and Cynthia Osterman, Reuters

[ Top ]

Diabetes Study Partially Halted After Deaths

February 7, 2008

For decades, researchers believed that if people with diabetes lowered their blood sugar to normal levels, they would no longer be at high risk of dying from heart disease. But a major federal study of more than 10,000 middle-aged and older people with Type 2 diabetes has found that lowering blood sugar actually increased their risk of death, researchers reported Wednesday.

The researchers announced that they were abruptly halting that part of the study, whose surprising results call into question how the disease, which affects 21 million Americans, should be managed.

The study’s investigators emphasized that patients should still consult with their doctors before considering changing their medications.

Among the study participants who were randomly assigned to get their blood sugar levels to nearly normal, there were 54 more deaths than in the group whose levels were less rigidly controlled. The patients were in the study for an average of four years when investigators called a halt to the intensive blood sugar lowering and put all of them on the less intense regimen.

The results do not mean blood sugar is meaningless. Lowered blood sugar can protect against kidney disease, blindness and amputations, but the findings inject an element of uncertainty into what has been dogma — that the lower the blood sugar the better and that lowering blood sugar levels to normal saves lives.

Medical experts were stunned.

"It’s confusing and disturbing that this happened," said Dr. James Dove, president of the American College of Cardiology. "For 50 years, we’ve talked about getting blood sugar very low. Everything in the literature would suggest this is the right thing to do," he added.

Dr. Irl Hirsch, a diabetes researcher at the University of Washington, said the study’s results would be hard to explain to some patients who have spent years and made an enormous effort, through diet and medication, getting and keeping their blood sugar down. They will not want to relax their vigilance, he said.

"It will be similar to what many women felt when they heard the news about estrogen," Dr. Hirsch said. "Telling these patients to get their blood sugar up will be very difficult."

Dr. Hirsch added that organizations like the American Diabetes Association would be in a quandary. Its guidelines call for blood sugar targets as close to normal as possible.

And some insurance companies pay doctors extra if their diabetic patients get their levels very low.

The low-blood sugar hypothesis was so entrenched that when the National Heart, Lung and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases proposed the study in the 1990s, they explained that it would be ethical. Even though most people assumed that lower blood sugar was better, no one had rigorously tested the idea. So the study would ask if very low blood sugar levels in people with Type 2 diabetes — the form that affects 95 percent of people with the disease — would protect against heart disease and save lives.

Some said that the study, even if ethical, would be impossible. They doubted that participants — whose average age was 62, who had had diabetes for about 10 years, who had higher than average blood sugar levels, and who also had heart disease or had other conditions, like high blood pressure and high cholesterol, that placed them at additional risk of heart disease — would ever achieve such low blood sugar levels.

Study patients were randomly assigned to one of three types of treatments: one comparing intensity of blood sugar control; another comparing intensity of cholesterol control; and the third comparing intensity of blood pressure control. The cholesterol and blood pressure parts of the study are continuing.

Dr. John Buse, the vice-chairman of the study’s steering committee and the president of medicine and science at the American Diabetes Association, described what was required to get blood sugar levels low, as measured by a protein, hemoglobin A1C, which was supposed to be at 6 percent or less.

"Many were taking four or five shots of insulin a day," he said. "Some were using insulin pumps. Some were monitoring their blood sugar seven or eight times a day."

They also took pills to lower their blood sugar, in addition to the pills they took for other medical conditions and to lower their blood pressure and cholesterol. They also came to a medical clinic every two months and had frequent telephone conversations with clinic staff.

Those assigned to the less stringent blood sugar control, an A1C level of 7.0 to 7.9 percent, had an easier time of it. They measured their blood sugar once or twice a day, went to the clinic every four months and took fewer drugs or lower doses.

So it was quite a surprise when the patients who had worked so hard to get their blood sugar low had a significantly higher death rate, the study investigators said.

The researchers asked whether there were any drugs or drug combinations that might have been to blame. They found none, said Dr. Denise G. Simons-Morton, a project officer for the study at the National Heart, Lung and Blood Institute. Even the drug Avandia, suspected of increasing the risk of heart attacks in diabetes, did not appear to contribute to the increased death rate.

Nor was there an unusual cause of death in the intensively treated group, Dr. Simons-Morton said. Most of the deaths in both groups were from heart attacks, she added.

For now, the reasons for the higher death rate are up for speculation. Clearly, people without diabetes are different from people who have diabetes and get their blood sugar low.

It might be that patients suffered unintended consequences from taking so many drugs, which might interact in unexpected ways, said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Or it may be that participants reduced their blood sugar too fast, Dr. Hirsch said. Years ago, researchers discovered that lowering blood sugar very quickly in diabetes could actually worsen blood vessel disease in the eyes, he said. But reducing levels more slowly protected those blood vessels.

And there are troubling questions about what the study means for people who are younger and who do not have cardiovascular disease. Should they forgo the low blood sugar targets?

No one knows.

Other medical experts say that they will be discussing and debating the results for some time.

"It is a great study and very well run," Dr. Dove said. "And it certainly had the right principles behind it."

But maybe, he said, "there may be some scientific principles that don’t hold water in a diabetic population."

By Gina Kolata, The New York Times

[ Top ]

News from the Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston

a. Circumcising HIV Positive Men May Increase HIV Infections in Female Partners, But Fewer STIs Seen
b. Abacavir, Didanosine Linked to Increased Heart Attack Risk
c. Vicriviroc Shows Well in Treatment-Experienced Patients
d. Atazanavir in Treatment-Naïve Patients
e. Treatment Interruptions
f. Another New CCR5 Inhibitor – SCH532706
g. HIV Treatment and Infectiousness
h. Lactobacillus Supplementation Could Help Reduce Vaginal HIV
i. Start Treatment At A CD4 Cell Count Of 500 To Reduce Risk Of Serious Non-HIV-Related Illnesses?
j. Drug Level Monitoring
k. Vaccine Failure
l. Once- vs. Twice-Daily Kaletra Tablets: Similar Safety and Potency
m. Sexual Reinfection With HCV Following Treatment
n. Anticipated 'Slam Dunk' AIDS Treatment Fails
o. People Receiving TB Treatment No More Likely to Die Than Others Who Start ARVs
p. Researchers Use Technique to Identify, Generate Molecules for Microbicide Research, Development
q. Benefits To Starting Immediate Treatment When A Patient Has An Opportunistic Infection
r. Biomarkers May Explain Risk of Treatment Interruptions
s. Research Points to the Prospect of a Once-Monthly Anti-HIV Drug
t. GeoVax Labs, Inc.'s Promising HIV/AIDS Vaccine Trial Data Presented at Retrovirus Conference
u. Effectiveness of Second-Line Therapy
v. Lymphomas
w. Treatment to Prevent Mother-To-Child Transmission
x. Children Infected With HIV from Pre-Chewed Food
y. Herpes and HIV Transmission
z. Gene Therapy Offers AIDS Hope
a. Circumcising HIV Positive Men May Increase HIV Infections in Female Partners, But Fewer STIs Seen

 February 3, 2008

There was a trend towards higher HIV incidence in the wives of HIV positive men who were circumcised compared with wives of men left uncircumcised, in the latest prevention study conducted in Rakai province, Uganda, investigators revealed at a press conference on the opening day of the Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston.

In 2006, a randomised trial of circumcision in Rakai reported that circumcision led to an almost 50% reduction in a man’s risk of acquiring HIV through heterosexual sex. The impact of male circumcision on transmission of HIV to the female partner remains unknown, and the study reported today set out to examine the effects.

In the Gates Foundation-funded study, 1015 HIV positive men were randomised either to immediate circumcision or circumcision delayed by two years. Of these 770 were married and were asked to invite their wives into the study; 566 wives enrolled of whom 245 (43%) were HIV-negative and therefore in a serodiscordant relationship.

The annual HIV incidence rate in the wives of the men who were circumcised was 14.4% over two years of follow-up compared with 9.1% in women whose partners remained uncircumcised. This result may be due to chance as it was not statistically significant, but was described as "unexpected and somewhat disappointing" by lead investigator Maria Wawer of Johns Hopkins University, Baltimore. It was not due to behavioural disinhibition; condom use was the same in both arms.

Wawer said that these results were an additional challenge to the rolling-out of mass circumcision programmes in Africa, which are expected following the positive results from three randomised controlled trials of circumcision in HIV negative men, one of them conducted within the Rakai community.

She said: "It is inevitable that some HIV positive men will seek circumcision. It is the only HIV prevention modality that leaves a mark, and no one wants to be the only guy in the village who is uncircumcised if it becomes regarded as a mark of HIV."

If the increased incidence in the partners of circumcised HIV-positive men is real and not due to chance, it may largely have been due to men resuming sex before their circumcision wound was certified as having healed, Wawer added. Five out of 18 wives of men who resumed sex more than five days prior to certified wound healing (28.8%) became HIV-positive themselves. In contrast six out of 63 wives of men who resumed sex no earlier than five days prior to certified wound healing were infected (9.5%) and this was statistically equivalent to six out of 68 wives of men who remained uncircumcised (8.8%).

After six months, HIV incidence declined to 5.7% a year in partners of circumcised men and 4.1% in wives of uncircumcised men, which was also not statistically significant.

The results may be partly due to HIV-positive men tending to heal more slowly from circumcision than HIV negative men. Seventy-one per cent of HIV positive men had healed completely by 30 days after circumcision, compared with 83.2% of HIV negative men.

Wawer said: "It is imperative people don’t resume sex in the post-operative period, and because of this slightly longer healing time we are saying don’t resume sex until six to eight weeks after the operation."

She added that even in the RCT in HIV negative men, the benefit from circumcision did not start to appear until more than six months after the operation.

Effect Of Circumcision On Stis

There was better news from this and another study of the effect of circumcision on sexually transmitted infections (STIs). In the Rakai study, the circumcised HIV-positive men had a third less genital ulcer disease (GUD) than those who remained uncircumcised (10.1% versus 15.8%) and this was statistically significant (p = 0.002). However rates of all STIs and of bacterial vaginosis were the same in wives of circumcised and uncircumcised men.

Another study presented by Aaron Tobian of the same team investigated the effect of circumcision on the acquisition of genital herpes (HSV-2) in HIV-negative men, and on the incidence of GUD, bacterial vaginosis and trichomonas in their wives.

There was a 25% reduction in HSV-2 acquisition in the circumcised men, and a 25% reduction in GUD, a 20% reduction in bacterial vaginosis, and a 50% reduction in trichomonas in their wives. Severe bacterial vaginosis fell by 60% (two per cent in wives of circumcised men versus 6.5% in wives of uncircumcised). All these results were statistically significant.

Among 62 men who became HIV-positive during the trial, 38 (61%) either had HSV-2 before the trial (47%) or seroconverted simultaneously to HIV and HSV-2 (14%).

"All the STIs observed are cofactors of HIV," Tobian commented. "These effects may influence the positive effect of circumcision on HIV acquisition."

References
Wawer M et al. Trial of circumcision in HIV+ men in Rakai, Uganda: effects in HIV+ men and women partners. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston. Abstract 33LB. 2008.

Tobian A et al. Trial of male circumcision: prevention of HSV-2 in men and vaginal infections in female partners, Rakai, Uganda. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston. Abstract 28LB. 2008.

By Gus Cairns, www.aidsmap.com


b. Abacavir, Didanosine Linked to Increased Heart Attack Risk

February 4, 2008

Abacavir—the active drug in Ziagen and a component of Epzicom and Trizivir—may double the risk of a heart attack in HIV-positive people currently using the drug, according to data presented today at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. The latest results from the international Data Collection on Adverse events of Anti-HIV Drugs (D:A:D) study also found an increased heart attack risk associated with current use of didanosine (Videx EC) but not other drugs in the nucleoside reverse transcriptase inhibitor (NRTI) class, including zidovudine (Retrovir) and stavudine (Zerit).

While most research has focused on the role of protease inhibitors and the risk of cardiovascular disease, little data have been generated regarding the potential association between NRTIs—which are almost always used in HIV drug combinations—and heart attacks. Zidovudine and stavudine are two NRTIs that have been linked to higher lipid levels and insulin resistance, two risk factors for heart disease. However, there hasn’t been any research showing that these two agents actually increase the risk of a heart attack.

Hypothesizing that stavudine and zidovudine do increase this risk, the D:A:D investigators examined their suspicions by turning to the D:A:D cohort of more than 33,000 HIV-positive patients who have been followed over the past seven years at clinics based in Europe, Australia and North America. To ensure balanced reporting, the D:A:D researchers also looked at the heart attack risk among those who have used, or are currently taking, the NRTIs abacavir, didanosine, and lamivudine (Epivir)—none of which have been tied to problems known to increase the risk of cardiovascular disease.

Surprising the researchers, an increased risk of a heart attack was documented only in patients currently receiving abacavir and didanosine. Abacavir use was associated with a 90 percent increased risk of experiencing a heart attack. Didanosine use was associated with a 49 percent increased risk of a heart attack.

Additional analysis suggested that the increased risk with these two drugs could be confirmed only in people currently using abacavir or didanosine. An increased risk was not found among past users of abacavir or didanosine, regardless of how long they were on treatment with either NRTI, provided that they had been discontinued at least six months previously. According to the study authors, this finding suggests that the potential cardiovascular effects of abacavir and didanosine are reversible if the drugs are stopped.

Neither past nor present use of stavudine or zidovudine increased the risk of a heart attack.

A position statement released by D:A:D study organizers, published on its website to coincide with the presentation of the data at CROI, suggests that these results need to be interpreted carefully and stresses that the effect of abacavir and didanosine was most pronounced in patients with a high underlying cardiovascular risk due to other factors.

"In people who start abacavir or [didanosine] with a low risk based on other factors," the authors of the position statement write, referring to those who are young, do not smoke, have no diabetes or high blood pressure, and normal cholesterol levels, "increasing the low risk by 90 percent still results in a low absolute risk of having a heart attack. However, in someone who starts off with a high risk of a heart attack based on other factors"—such as a cigarette smoker, who has a 2- to 3-fold greater risk of a heart attack, compared with the 1.90-fold increase associated with abacavir treatment—"increasing this existing high risk by 90 percent means that the additional effect from abacavir or [didanosine] will be more important."

The D:A:D investigators did not offer a potential explanation for these "surprising and unexpected" findings. Additional research will be needed to explore the link between heart attacks and the use of abacavir or didanosine.

The authors of position statement also note that patients receiving abacavir or didanosine should consult with their health care providers to discuss whether a modification of their current drug regimen is appropriate.

By Tim Horn, http://www.poz.com


c. Vicriviroc Shows Well in Treatment-Experienced Patients

February 4, 2008

Forty-eight weeks of therapy with vicriviroc, notably a 30 mg once-daily dose of the drug combined with a Norvir (ritonavir) booster, leads to greater viral load reductions compared with placebo among HIV-positive patients with limited treatment options due to drug resistance. These new data, from a clinical trial involving Schering-Plough’s experimental CCR5 inhibitor, were reported today at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

After HIV binds to the CD4 protein on T cells, the virus must then latch onto another receptor on the cell's surface, either CCR5 or CXCR4. Vicriviroc, like Pfizer’s approved twice-daily entry inhibitor Selzentry (maraviroc), prevents HIV from entering CD4 cells that carry the CCR5 receptor. Both drugs are largely ineffective against virus that uses, or is tropic for, the CXCR4 receptor.

The 116 patients enrolled in Schering-Plough’s Phase II VICTOR-E1 study had tried and failed drug regimens involving all three classes of oral HIV drugs and had viral loads of at least 1,000 copies while on their previous treatment regimen. The patients all had CCR5-tropic virus upon study entry, confirmed using Monogram Bioscience’s Trofile assay.

Study volunteers were randomized to once-daily vicriviroc—either 20 mg or 30 mg—with a low-dose Norvir booster, or placebo, all in combinations with an optimized background regimen (OBR) containing at least three approved HIV drugs.

The 48-week results from VICTOR-E1 were reported at CROI by Barry Zingman, MD, of Montefiore Medical Center in the Bronx, New York.

After almost a year of treatment, 14 percent of the patients had viral loads below 50 copies in the placebo group, compared with 56 percent in the 30 mg vicriviroc group and 52 percent in the 20 mg vicriviroc group. Compared with those in the placebo group, the percentages of patients with undetectable viral loads were statistically significant in both vicriviroc groups.

While patients who entered VICTOR-E1 with high viral loads were less likely to respond favorably to vicriviroc-based treatment, those who received the 30 mg dose of the drug had the best chance of sustained treatment response. Among those who entered the study with viral loads of 100,000 or higher, 33 percent in the 30 mg vicriviroc group, compared with 17 percent in the 20 mg group and 10 percent in the placebo group, had undetectable viral loads after 48 weeks.

As for patients who entered the study with viral loads below 100,000 copies, 33 percent in the placebo group, compared with 67 and 68 percent in the 30 mg and 20 mg vicriviroc groups respectively, had viral loads below 50 copies after 48 weeks. 

Given that CCR5 inhibitors target a cellular receptor instead of a viral enzyme, drug resistance is thought be much less of a problem with vicriviroc. However, patients’ viruses can switch from CCR5-tropic to CXCR4-tropic while using a CCR5 inhibitor. This was documented in 9 percent of the placebo recipients in VICTOR-E1, compared with 23 percent in the 30 mg vicriviroc group and 10 percent in the 20 mg vicriviroc group.

Virologic failures—having a viral load that failed to go undetectable or rebounded during the study—were documented in 40 percent of the placebo recipients, compared with 18 percent in the 30 mg vicriviroc group and 8 percent in 20 mg vicriviroc group.

In summary, Norvir-boosted vicriviroc plus OBR is associated with significant long-term virologic control in treatment-experienced patients. Given the more favorable treatment response using the 30 mg dose of the drug—along with additional data presented by Dr. Zingman showing that the 30 mg dose was more likely to achieve therapeutic blood levels than the 20 mg dose—the higher once-daily dose of vicriviroc should be explored more closely in Phase III studies of the drug. 

By Tim Horn, http://www.poz.com


d. Atazanavir in Treatment-Naïve Patients

February 5, 2008

Atazanavir (Reyataz) is not recommended for first-line anti-HIV therapy in current UK HIV treatment guidelines. Kaletra(lopinavir/ritonavir) is recommended by these guidelines for treatment-naïve patients and is a popular choice amongst patients who opt to start treatment with a protease inhibitor.

Atazanavir has some advantages, in particular it is only taken once-daily and seems less likely to cause diarrhoea than other protease inhibitors.

A study presented to CROI showed that atazanavir boosted by ritonavir could be a safe and effective option for people starting anti-HIV treatment. It showed that patients who started antiretroviral therapy with a combination of drugs that included once-daily atazanavir were just as likely as patients who started treatment with a regimen containing twice-daily Kaletra to have an undetectable viral load (below 50 copies/ml) after a year.

CD4 cell counts increased equally in patients taking the two drugs.

Fewer patients taking atazanavir experienced nausea or diarrhoea and blood fats were also lower in atazanavir-treated patients. But atazanavir can cause a side-effect called hyperbilirubinaemia that involves a non-dangerous yellowing of the skin and whites of the eyes.

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e. Treatment Interruptions


February 5, 2008

Two years ago the SMART treatment interruption study was stopped early when it was found that patients who took CD4-guided treatment breaks were more likely to develop HIV-related illnesses and some serious non-HIV-related illnesses than individuals who took continuous HIV treatment.

Further results from the SMART study presented to this year’s CROI showed that treatment interruptions could have long-term consequences.

These showed that in the 18 months after the study was concluded, rates of HIV-related opportunistic infections and death from any cause remained higher in patients who took treatment interruptions than in patients who took their HIV therapy continuously.

The investigators suggest that "antiretroviral therapy interruption is associated with long-term consequences beyond the period of treatment interruption."

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f. Another New CCR5 Inhibitor – SCH532706

February 5, 2008

Another CCR5 inhibitor being investigated in clinical trials in SCH532706. The potency of this drug is boosted by ritonavir.

The drug is in the early phases of development, but results from twelve HIV-positive patients (four of whom were taking anti-HIV treatment for the first time) show that ten days of treatment with SCH532706/ritonavir significantly lowered viral load and increased CD4 cell count.

The most common side-effect was an upset stomach, but one person did develop inflammation of the sac around the heart (pericarditis), which the researchers think was "possibly related" to the drug.

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g. HIV Treatment and Infectiousness

February 5, 2008

Last week Swiss HIV experts issued a statement saying that individuals taking anti-HIV therapy who have an undetectable viral load in their blood for six months or more and who do not have a sexually transmitted infection should not be considered able to transmit HIV to their sexual partners.

It was a controversial statement, but it has helped focus attention on the ability of antiretroviral therapy to reduce HIV transmissions.

Now a study conducted in Uganda and presented to CROI suggests that anti-HIV treatment combined with safer sex education and adherence support could cut HIV transmissions by 91%.

The study lasted three years. There were 62 couples in the study where one partner was HIV-positive and the other HIV-negative. Only one partner became infected with HIV during the study and this infection happened soon after anti-HIV treatment was started.

It is thought the single infection happened because the infected woman’s husband had a slow response to anti-HIV therapy and took six months to achieve an undetectable viral load.

www.aidsmap.com



h. Lactobacillus Supplementation Could Help Reduce Vaginal HIV

February 5, 2008

The composition of the vaginal microflora affects the viral load within the vaginal secretions of HIV-positive women, according to a late-breaking abstract presented on Monday at the Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston.

Lead author Jane Hitti of the University of Washington at Seattle said that about 50% of the women studied at any time had hydrogen peroxide-producing (H2O2+) Lactobacillus, which is found in the microflora of a healthy vagina. The change in vaginal microflora seen in bacterial vaginosis, and especially the loss of H2O2+ Lactobacillus, is associated with increased risk of HIV infection.

There is a dynamic relationship between the Lactobacillus and the bacteria that cause bacterial vaginosis, Hitti said. BV-associated bacteria appear to actively increase HIV replication while the H2O2+-producing bacteria inhibit it.

In a prospective, observational cohort study, which assessed the effect over time of H2O2+ Lactobacillus colonisation on HIV viral load in vaginal secretions, women whose bacterial microflora switched from those cause BV to those Lactobacillus experienced a 0.7 log (fivefold) drop in the HIV viral load in vaginal secretions (cervico-vaginal lavage or CVL). Conversely, a switch from Lactobacillus to BV bacteria signalled a 0.5 log (threefold) increase in CVL viral load.

For the study, 57 HIV-1-infected women from Seattle and from Rochester, NY were recruited and followed every three to four months for a median of six visits per woman (range one to 15 visits, with four in the first year and three a year thereafter). At each visit, plasma and CVL viral loads were determined, and cultures to identify H2O2+ Lactobacillus and BV bacteria were performed and the women were also tested for gonorrhoea, trichomoniasis and chlamydia.

At the start of the study, 31 (54%) women were on antiretroviral therapy and 22 (39%) had an undetectable viral load (<30 copies/mL). Lactobacillus was present in 32 women, 18% of whom had clinical signs of BV; it was absent in 25 women, 47% of whom had clinical BV.

During the study, blood viral load was detectable at 64% of visits and CVL viral load was detectable (>1500 copies/mL) at 17% of visits; CVL viral load was highly correlated with plasma viral load (p<0.001), but not antiretroviral therapy (p<0.78).

The presence of H2O2+-producing bacteria was in itself associated with a threefold reduction in CVL viral load (p = <0.01) and BV bacteria with a 60% increase (p= 0.015). Trichomonas was also associated with a threefold increase in viral load but because infections were less common, this was not statistically significant.

The data yielded 270 visit pairs suitable for analysis of changes in microflora. Colonisation by H2O2+ Lactobacillus was dynamic over time. While almost half, 121 (47%), of visit pairs had stable colonisation between visits, 39 (15%) visit pairs reported the appearance of the bacterium between visits. A similar number, 36 (14%) visit pairs, reported the loss of the bacterium between visits, and 62 (24%) showed no evidence of colonisation at either visit.

As described above, appearance of the H2O2+ Lactobacillus between visits was associated with a 0.7 log10 decrease in CVL viral load (p = 0.015), and loss of the bacterium resulted in a 0.5 log10 increase in CVL viral load (p = 0.029) when compared with stable colonisation. All results were adjusted for changes in plasma viral load and antiretroviral therapy status, but not for herpes (HSV-2) status or shedding – one limitation of the study.

When clinical BV was present, women were treated for it, but Hitti commented that treating BV got rid of the associated bacteria but was not necessarily associated with the reappearance of Lactobacillus.

Hitti commented that these changes in CVL viral load associated with changes in vaginal microflora might one day inform positive prevention strategies for HIV-positive women. She said "If a probiotic replacement proves to be effective this could be an important strategy."

However, she added, although there had been a few studies to see if supplementation with Lactobacillus formulations could re-establish stable colonisation in HIV-negative women, she was unaware of any studies done in HIV-positive women, and hoped funding would be forthcoming for one.

Asked to comment on women possibly trying over-the-counter supplements, Hitti commented that the vaginal Lactobacillus was "a cousin" of those found in yoghurt and derived supplements and would not necessarily have the same H2O2+-secreting properties or effect on HIV.

Reference
Hitti J et al. Protective Effect of Vaginal Lactobacillus on Genital HIV-1 RNA Concentrations: Longitudinal Data from a US Cohort Study. 15th Conference on Retroviruses and Opportunistic Infections, Boston, abstract 27LB, 2008.

By Gus Cairns & Virginia Differding, www.aidsmap.com

i. Start Treatment at a CD4 Cell Count Of 500 to Reduce Risk of Serious Non-HIV-Related Illnesses?

February 6, 2008

Treatment guidelines (such as those in Europe and the US) are now recommending that HIV treatment should be started when an individual’s CD4 cell count is around 350 cells/mm3. Previous guidelines recommended the initiation of treatment when a patient’s CD4 cell count was around 200 cells/mm3.

These were changed when studies showed that patients who started treatment at higher CD4 cell counts had much better long-term improvements in their immune system. Furthermore, results from the SMART treatment interruption study showed that a low CD4 cell count increased the risk of serious non HIV-related illness, such as some cancers as well as heart, kidney and liver disease.

But could treatment guidelines soon be recommending starting treatment at an even higher CD4 cell count? There is evidence from the UK that patients with a CD4 cell count of 350 cells/mm3 have more HIV-related illnesses and a greater risk of death than patients with a CD4 cell count of 500 cells/mm3.

Prof Andrew Phillips of London’s Royal Free Hospital analysed results from a number of studies showing that HIV may have an important role in some serious non-HIV-related illnesses. He suggested that the earlier use of antiretroviral therapy could reduce the risk of these illnesses.

"We need to be looking at whether antiretroviral therapy should be initiated earlier in patients with CD4 cell counts above 500 [cells/mm3]", Prof Phillips told CROI delegates.

www.aidsmap.com


j. Drug Level Monitoring

February 6, 2008

Increasing doses of protease inhibitors after therapeutic drug monitoring does not improve the overall chance of treatment-experienced patients achieving and maintaining an undetectable viral load, according to a US study presented to CROI.

Although this strategy had no benefit for Caucasian patients, it did have a modest effect on the viral load of black and Hispanic individuals.

The study involved 194 patients who had experience of at least one protease inhibitor, but who still had a viral load above 1000 copies/ml.

Four weeks after changing treatment to a new protease inhibitor-based combination they had levels of medicines in their blood monitored. Patients with low blood concentrations of drugs were randomised to either continue with their current protease inhibitor dose or to have the dose of their protease inhibitor increased.

But 20 weeks later, viral load was more or less the same in both groups of patients.

When the researchers looked at the results in more detail, they found that increasing the dose of protease inhibitors had better results in black and Hispanic patients than in white patients.

The amount of resistance a patient had to protease inhibitors also seemed to be important. Those with least protease inhibitor resistance had the biggest reductions in viral load after the doses of their new protease inhibitor were increased.
www.aidsmap.com

k. Vaccine Failure

February 6, 2008

Last year, the study looking at Merck’s potential HIV vaccine, ad5, was stopped when it was shown that people who received the vaccine had a higher risk of infection with HIV than those who received the placebo.

A detailed analysis of the trial’s results was presented to CROI:
http://www.aidsmap.com/en/news/E30B88ED-2A6C-44D3-9AF6-61DB62FD9D0D.asp
This showed that the increased risk of HIV was almost entirely located in uncircumcised men who had unprotected insertive anal sex.

Researchers think that the vaccine may have interfered with the men's natural immune responses to HIV. This might have been related to the men’s immunity to adenovirus, a common cold-type virus, that was used as the vaccine’s "delivery vehicle."

www.aidsmap.com

l. Once- vs. Twice-Daily Kaletra Tablets: Similar Safety and Potency

February 5, 2008

Once- and twice-daily doses of Kaletra (lopinavir/ritonavir) tablets have similar tolerability and comparable efficacy, according to 48-week results from a clinical trial reported yesterday at the 15th Conference on Retroviruses and Opportunistic Infections (CROI).

In the United States, Kaletra has been approved by the U.S. Food and Drug Administration (FDA) for use once or twice daily in people starting HIV treatment for the first time, with a total daily dose of 800 mg lopinavir and 200 mg ritonavir using either schedule. Only twice-daily dosing is approved for treatment-experienced patients. 

Despite approval from the FDA, there have been lingering concerns about the safety and effectiveness of once-daily Kaletra therapy in treatment-naive patients.

Initial studies comparing once- and twice-daily Kaletra involved the original capsule formulation of the drug. While the effectiveness of once-daily Kaletra was found to be comparable to twice-daily dosing, diarrhea rates were higher in the once-daily group.

Abbott eventually brought a tablet version of the drug to market that, according to a study of patient surveys in October 2006, was less likely to cause diarrhea.

Questions soon emerged about the effectiveness of the drug taken once daily, notably in patients starting therapy for the first time with high viral loads (100,000 copies or higher). This was explored, in some detail, in two presentations at the 11th European AIDS Conference this past October in Madrid.

While Kaletra remains a "preferred" protease inhibitor for HIV-positive individuals starting therapy for the first time, the U.S. Department of Health and Human Service’s most recent version of its federal treatment guidelines—updated January 29, 2008—suggests that twice-daily Kaletra may be a more suitable dosing option for those with high pre-treatment viral loads.  

To better understand the safety and efficacy of once- and twice-daily dosing of the Kaletra tablets—and to formally compare Kaletra tablets with Kaletra capsules—Abbott funded an international study involving 600 HIV-positive patients beginning antiretroviral therapy for the first time. For the first eight weeks of the study, the patients were divided into four groups: one group took twice-daily Kaletra tablets, a second group took twice-daily Kaletra capsules, a third group took once-daily Kalera tablets, and a fourth group took once-daily Kaletra capsules.  From there, patients in the once-daily Kaletra groups were maintained on once-daily Kaletra tablets; patients in the twice-daily Kaletra groups continued the study using twice-daily Kaletra tablets.

All patients received standard doses of Viread (tenofovir) and Emtriva (emtricitabine) throughout the study.

According to Joe Gathe, MD, a Houston-based researcher who presented the results of Study M05-730 at CROI, approximately 78 percent of the study volunteers were male and roughly 75 percent were white. Average viral loads at the start of the study were almost 100,000 copies, with an even distribution of patients with viral loads below and above this level. CD4 counts at baseline averaged 215 cells.

In the comparison between Kaletra capsules and tablets, no significant differences in the side effects of the two formulations were reported—rates of mild-to-severe diarrhea were similar in all four groups of patients during the first eight weeks of the study.

As for the the comparison between once- and twice-daily Kaletra tablets—the predominant focus of the CROI presentation—77 percent in the once-daily Kaletra group and 76 percent in the twice-daily Kaletra group had viral loads below 50 copies after 48 weeks. As this difference was so slight, the once-daily results were said to be "non-inferior" to the twice-daily findings—comparable efficacy between the two groups.

There were no statistically significant differences in treatment responses between the two groups among those who entered with viral loads above or below 100,000. Similarly, there were no statistically significant differences in the virologic response to once- or twice-daily Kaletra treatment among those who entered with CD4 counts below 50 cells, between 50 and 200 cells, or above 200 cells.

Seven patients had resistance testing available—10 in the once-daily group and seven in the twice-daily group—through week 48. No resistance to lopinavir or tenofovir was documented. Three—two in the once-daily group and one in the twice-daily group—had HIV that developed the M184V mutation, conferring high-level resistance to Emtriva.

As for side effects, rates of moderate or severe diarrhea were similar between the two groups, occurring in 17 percent of those in the once-daily Kaletra group and 15 percent of those in the twice-daily Kaletra group. Moderate or severe nausea occurred in 7 and 5 percent and vomiting in 3 and 4 percent, respectively.

Moderate or severe lab abnormalities, such as liver enzyme increases, cholesterol gains, triglyceride elevations and decreases in creatinine clearance, generally occurred in less than 5 percent of the patients enrolled in the clinical trial, with no statistically significant differences between the two study groups.

The only statistically significant difference between the two groups was the change in total cholesterol after 48 weeks of treatment: a gain of 29 mg/dL in the once-daily Kaletra group, compared with a 34.5 mg/dL gain in the twice-daily Kaletra group.

Finally, Dr. Gathe ad his colleagues explained that study volunteers who switched from Kaletra capsules to tablets after the first eight weeks of the study, "overwhelmingly preferred" the tablets to the capsules.

The researchers concluded, "This study is the largest study to date comparing once-daily and twice-daily dosing of Kaletra, and the first utilizing the tablet formulation. Overall, during the first 48 weeks of treatment, no clinically important differences were identified in the safety and tolerability of once-daily vs. twice-daily dosing of Kaletra."

By Tim Horn, http://www.aidsmeds.com


m. Sexual Reinfection with HCV Following Treatment

February 4, 2008

Reinfection with hepatitis C virus (HCV), after undergoing successful treatment for the liver infection, can occur following a subsequent sexual exposure to the virus, according new data involving eight gay and bisexual HIV-positive men reported today at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Evidence confirming that HCV can be spread sexually continues to mount, with the vast majority of reports involving men who have sex with men. There’s also no shortage of research confirming that individuals who successfully undergo a year of toxic antiviral treatment for HCV are not always in the clear—some patients see a relapse of their infection, whereas others can be reinfected with another strain of HCV via the same transmission route responsible for their first infection with the virus.

Rachel Jones, MD, of the Chelsea and Westminster NHS Foundation Trust in London, and her colleagues set out to determine whether infection relapse or reinfection was to blame for a resurgence of detectable HCV viral loads in a small group of HIV-positive gay and bisexual men, several months after being successfully treated for the hepatitis C.

The researchers first queried databases at both Chelsea and Westminster and Royal Free Hospitals to find individuals with detectable HCV viral loads following a sustained virologic response (SVR) to initial hepatitis C treatment. An SVR is typically defined as an undetectable HCV viral load for at least six months after spontaneously clearing the infection or following completion of standard treatment: pegylated interferon plus ribavirin.

Once the individuals were found, the genes from their HCV samples—collected during the first and second period of detectable virus—were compared. Sexually transmitted infection diagnoses during the HCV SVR—a potential marker of sexual behavior that may have facilitated a transmission of a second hepatitis C virus—were also recorded in the database.

Of the 211 HIV/HCV-coinfected individuals in the data, 16 had at least two episodes of HCV infection, with the second episode typically diagnosed following a routine liver function test. All were men who have sex with men. They had been infected with HIV for approximately four years and, on average, were 38 years old when they were diagnosed with the initial HCV infection. The average length of the SVR, between periods of detectable HCV, was 20 months.

Dr. Jones’s group was able to collect paired samples from eight of the individuals. Genetic analysis revealed two individuals with viruses that were similar enough to indicate late relapse. In the remaining six, there were enough differences between the paired viruses to indicate reinfection with different strains.

All but two individuals had at least one sexually transmitted infection during their SVR periods, syphilis being the most common.

In conclusion, Dr. Jones and her colleagues suggest that six of the men were likely reinfected with HCV after successfully completing treatment for an initial infection. These reinfections, the authors said, were likely related to ongoing high-risk sexual activity. In the other two patients, the strains were closely related, likely indicative of a late relapse of the infection—or possibly reinfection from a common source.

By Tim Horn, http://www.aidsmeds.com

 

n. Anticipated 'Slam Dunk' AIDS Treatment Fails

February 5, 2008

Boston -- A once-promising experiment to see whether treating genital herpes with a common drug could dramatically reduce susceptibility to HIV infection has found no protection whatsoever - a shocking setback for researchers hoping to find a pill that would slow the spread of the AIDS epidemic.

Results of the long-awaited study, which included gay men in San Francisco, Seattle, New York and Peru, as well as women in Africa, were released in Boston Monday at the 15th annual Conference on Retroviruses and Opportunistic Infections, the premier annual scientific meeting of AIDS researchers.

Nearly 20 years of various studies on herpes had shown that herpes infection nearly tripled the risk of contracting HIV. The assumption was simple: Use acyclovir, a proven anti-herpes drug, to knock down that infection, and the odds of avoiding HIV would dramatically improve - by at least 50 percent, on par with the prevention benefit now attributed to male circumcision.

Results of the experiment were shielded from researchers and subjects alike until the study was completed, but when statisticians tabulated their data, the answer was certain. Those who took acyclovir to suppress their herpes infections acquired HIV infections at exactly the same rate as those who took a placebo.

"This was a huge setback for HIV prevention," said Dr. Sharon Hillier, a researcher at the Magee-Womens Research Institute at the University of Pittsburgh.

Scientists had a lot of reasons to think that the results of this study could be as exciting as the findings in 2005 and 2006 that adult male circumcision - the surgical removal of the foreskin - reduced by as much as 60 percent the risk that those men would contract HIV.

"Many people thought this was going to be a slam dunk," said Dr. Connie Celum, the University of Washington professor who led the study since it was approved in 2004.

"It was definitely disappointing, but it was also very clear," she said of the result.

Her experiment was often compared to the circumcision trials, because the researchers were aiming for the same fence: to prove that the intervention could reduce HIV infections by half. Circumcision is believed to lower HIV risk because the foreskin is rich in infection-fighting white blood cells that are targets particularly favored by the AIDS virus. Similarly, there have been studies showing that the lesions created by herpes infection are portals of entry for HIV.

And as was the case with circumcision, this carefully monitored trial was based on years of prior studies that strongly suggested the idea would work.

"This was the study everyone thought they had already had the answer to," said Dr. Eric Goosby, chief executive of the Pangaea Global AIDS Foundation in San Francisco. "So much for that."

Now, the long and difficult task is to find out why the approach did not work, and what might be done to come up with different outcome.

The theory that immediately jumped to the top of the list of possibilities is that suppressing herpes was not enough. Although acyclovir is a very effective treatment for herpes simplex 2, it does not eradicate it, and many of those who take acyclovir will continue to have occasional flareups of genital ulcers.

One puzzle facing scientists is that the acyclovir treatments reduced herpes lesions by different percentages in different groups: 32 percent among African women, 41 percent among gay men in Peru, and 50 percent among gay men in the United States. But prior studies had shown the drug was capable of 80 percent suppression.

"This is the real crux of the problem," Celum said. "We need to try to understand it."

A possible solution would be to increase the dosage of the anti-herpes drug beyond the two tablets a day used in this experiment. However, Celum said that other experiments have shown no real improvement in herpes suppression with higher-than-standard doses.

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said the results were disappointing. "I would have thought we would have seen at least some effect," he said.

Despite the experiment's failure, Celum said that her team will continue its work on another major study testing whether the anti-herpes drug might block certain HIV infections involving couples. This one will treat herpes in HIV-infected men or women whose sexual partner is HIV-negative, and may or may not have herpes. The experiment will attempt to show that by taking acyclovir, the HIV-infected person will be less infectious, and far less likely to transmit the AIDS virus to his or her partner. The study is winding up in June, and results should be ready in about a year.

Dr. Kevin De Cock, director of the department of HIV/AIDS at the World Health Organization, said he was disappointed by the results of the study, but not entirely surprised. "What we really need," he said, "is a herpes vaccine."

Such a vaccine has eluded drugmakers for decades, despite the clear need in societies that could afford to pay for one. Although a herpes vaccine tested by Chiron Corp. of Emeryville failed in clinical studies, the National Institutes of Health is sponsoring trials of other candidates.

By Sabin Russell, San Francisco Chronicle


o. People Receiving TB Treatment No More Likely to Die Than Others Who Start ARVs

February 6, 2008

People receiving treatment for pulmonary TB are no more likely to die if they start antiretroviral treatment than their counterparts without TB, according to findings from South Africa presented today at the Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston. The only exception to this finding is malnourished people with TB who start ART less than 30 days after starting TB treatment.

The study was carried out because there are conflicting data from resource-limited settings regarding the impact of active tuberculosis on the risk of death in HIV-positive patients starting antiretroviral therapy.

To gain a better understanding of this issue investigators from the University of North Caroline School of Public Health and the Themba Lethu Clinic in Johannesburg performed a retrospective study. They wanted to see if patients with active tuberculosis when they started anti-HIV treatment had an increased risk of death or loss to follow-up (for reasons other than transferring care to another HIV treatment centre) than tuberculosis-free patients.

The study ran between April 2004 and August 2007. Of the 7519 clinic patients who started antiretroviral therapy during this period, 1202 (16%) had active tuberculosis and were included in the investigators’ analysis. Of these patients, 284 received tuberculosis treatment for 30 days or less before anti-HIV treatment was started.

HIV disease status was worse in patients with active tuberculosis than the patients who did not have tuberculosis at the time antiretroviral therapy was started. CD4 cell counts (77 cells/mm3 vs. 113 cells/mm3, p < 0.001) were lower in patients with tuberculosis, as was haemoglobin (79% of tuberculosis patients having low haemoglobin compared to 56% of other patients, p < 0.001). Patients with tuberculosis were also significantly more likely than the non-tuberculosis patients to start anti-HIV therapy with a regimen that included efavirenz (95% vs. 78%).

Overall there was no difference in the risk of death or loss to follow-up for patients with or without active tuberculosis in the twelve months after anti-HIV therapy was initiated.

Multivariate analysis showed that there was a significantly elevated risk of death only in the group of patients at greatest risk of HIV disease progression: those with a CD4 cell count below 50 cells/mm3 and those with a low body mass index (BMI below 18.5m2).

This analysis showed that patients receiving fewer than 30 days of tuberculosis therapy who had a low body mass index were significantly more likely to die or be lost to follow-up than non-tuberculosis patients with a low body mass index (incidence rate ratio [IRR] = 5.6; 95% CI, 2.46 – 12.74). Furthermore, patients who received over 30 days of therapy for active tuberculosis before initiating antiretroviral therapy and who had a very low CD4 cell count were significantly more likely to have a poor outcome than tuberculosis-free patients starting anti-HIV treatment with a CD4 cell count below 50 cells/mm3 (IRR = 4.26; 95% CI, 2.42 – 7.47).

"Our results suggest that individuals receiving tuberculosis treatment are not at increased risk of death after [antiretroviral therapy] initiation", comment the investigators. They add, however, "individuals with additional risk factors, such as low body mass index and low CD4 counts may have substantially increased risks."

Reference

Westreich D et al. The influence of TB on early mortality in the Themba Lethu clinical cohort, Johannesburg, South Africa. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston. Abstract 145, 2008.

By Michael Carter, www.aidsmap.com

p. Researchers Use Technique to Identify, Generate Molecules for Microbicide Research, Development

February 6, 2008

Researchers from Case Western Reserve University in Ohio have used a technique called phage display to identify and generate molecules for use in microbicide research and development, according to a study presented Monday at the 15th Conference on Retroviruses and Opportunistic Infections in Boston, the Cleveland Plain Dealer reports (McEnery, Cleveland Plain Dealer, 2/5). Microbicides include a range of products -- such as gels, films and sponges -- that could help prevent the sexual transmission of HIV and other infections (Kaiser Daily HIV/AIDS Report, 12/20/07).

For the study, Michael Lederman, director of Case's Center for AIDS Research, and colleagues used phage display to generate molecules that act like an experimental drug -- called PSC-RANTES -- that was found to block the vaginal transmission of SIV in monkeys. The drug also could be used in the development of a microbicide for use among humans, according to the Plain Dealer. PSC-RANTES closes molecular receptors that HIV uses to replicate, but its production is "incredibly expensive," according to the Plain Dealer.

Using phage display, the researchers identified and generated three molecules that prevented HIV from entering cells. Because the molecules occur naturally in the body, they can be produced at a lower cost compared with PSC-RANTES, the Plain Dealer reports. The study also found that in addition to being antiviral agents, two of the molecules did not appear to produce any serious immunological reactions. The researchers will present the findings at a microbicide conference in India later this month and hope to attract funding for further research (Cleveland Plain Dealer, 2/5).

http://www.kaisernetwork.org

q. Benefits To Starting Immediate Treatment When A Patient Has An Opportunistic Infection

February 7, 2008

Patients who are ill because of HIV-related opportunistic infections are generally recommended to start anti-HIV therapy as soon as possible.

Introducing anti-HIV therapy whilst a patient is still receiving treatment for their opportunistic infection reduces the risk of risk of death or further disease progression, compared to waiting until treatment for the opportunistic infection is completed, and doesn’t increase the risk of side-effects, a study presented to CROI shows.

US researchers compared two groups of patients who were ill because of HIV and who were not taking antiretroviral therapy. One group of patients started anti-HIV therapy and treatment for their opportunistic infection at the same time. The other group of patients waited to start anti-HIV treatment until they’d completed therapy for their infection.

The study didn’t include patients with tuberculosis.

Overall, just under half the patients taking immediate or deferred anti-HIV treatment experienced no further HIV disease progression and managed to get their HIV viral load to undetectable levels.

But further analysis of the results showed that patients who deferred anti-HIV treatment were about 50% more likely to develop another AIDS-defining illness or die than those taking immediate treatment. And CD4 cell counts increased at a slower rate in those waiting to start treatment.

Starting treatment immediately didn’t have any additional risks. There were no difference in rates of adherence between the two groups of patients. Nor was there any difference in the risk of developing an immune reconstitution inflammatory syndrome once treatment was started.

www.aidsmap.com

r. Biomarkers May Explain Risk of Treatment Interruptions

January 7, 2008

Patients who take treatment interruptions have indicators of increased inflammation as well as dysfunction in the lining of the blood vessels. This could explain the increased risk of illness and death due to diseases not usually associated with HIV, such as heart, kidney and liver disease, seen in the SMART study.

Researchers looked at the results of the SMART and STACCATO treatment interruption studies. They told CROI that HIV replication during structured treatment breaks affected key biomakers that indicate inflammation, increased blood clotting and endothelial dysfunction – reduced flexibility in the lining of blood vessels, an early sign of heart disease.

www.aidsmap.com


s. Research Points to the Prospect of a Once-Monthly Anti-HIV Drug

January 7, 2008

Once-daily anti-HIV treatment was considered a breakthrough, but researchers are now developing an anti-HIV drug that might need to be taken just once a month.

An experimental NNRTI called rilpivirine has been formulated with nanoparticles. Results in animals suggest that once-monthly injections could be enough to treat HIV.

Researchers are trying to find other drugs that could be formulated in a similar way. This could mean that potent, multi-drug anti-HIV treatment could be developed that is injected monthly.

This technology could also be used for HIV prevention to provide long-lasting pre-exposure prophylaxis or a as a microbicide.

www.aidsmap.com


t. GeoVax Labs, Inc.'s Promising HIV/AIDS Vaccine Trial Data Presented at Retrovirus Conference
Planning for Phase 2 is Underway

February 7, 2008

Atlanta - Dr. Harriet Robinson, lead scientist and co-founder of GeoVax Labs, Inc., (OTC Bulletin Board: GOVX - News) an Atlanta-based biotechnology company developing HIV/AIDS vaccines, co-presented successful Phase I trial results at the 15th Conference on Retroviruses and Opportunistic Infections (CROI), February 5 in Boston.

Dr. Robinson, a co-founder of the GeoVax HIV-1 AIDS vaccine technology, jointly presented the findings, entitled "GeoVax Clade B DNA/MVA HIV/AIDS Vaccine is Well Tolerated and Immunogenic when Administered to Healthy Seronegative Adults," with Dr. Bernard Moss of the U.S. National Institutes of Allergy and Infectious Diseases and co-founder of the GeoVax vaccine.

In the presentation, Robinson reported that a dose escalation study showed that a 1/10th dose and an anticipated normal dose of the GeoVax vaccine both elicit anti-viral CD4 and anti-viral CD8 T cells. However, the fuller dose elicited a higher number of antibody responders.

For the normal dose, 77 percent of the participants had responding CD4 T cells; 42 percent had responding CD8 T cells, and 88 percent experienced an anti-Env antibody response. The vaccine was also found to be safe.

Based on the excellent immune response rates and the GeoVax HIV/AIDS vaccine's ability to protect non human primates against AIDS development in pre-clinical challenge models, planning of a large Phase 2 trial is underway and tentatively scheduled for a mid-2008 start.

As recently announced, due to the significant advances by GeoVax's HIV/AIDS vaccine development program, Dr. Robinson is joining the GeoVax management full time on February 15, 2008, as Vice President of Research and Development. By focusing her efforts exclusively at GeoVax, Dr. Robinson intends to speed up the vaccine development and human trial evaluation program required to meet FDA regulatory requirements and future vaccine commercialization efforts.

Dr. Robinson stated, "Our AIDS vaccine efforts are rapidly moving forward to a new and exciting level and include plans for initiating Phase 2 human trials in 2008. It's important to me to be able to work full time with the GeoVax team to learn absolutely everything we can from our phase 2 trials so that we appropriately set the stage for phase 3 efficacy trials. I believe in the GeoVax vaccine and want to carry it forward as rapidly and as effectively as possible for worldwide use for the prevention of AIDS."

The HIV Vaccine Trials Network (HVTN) in Seattle is testing GeoVax's HIV/AIDS vaccines. HVTN funded and supported by the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. The National Institute of Allergy and Infectious Diseases of the U.S. National Institute of Health funded pre-clinical work enabling the development of the clinical evaluation of GeoVax's DNA and MVA vaccines.

The NIH recently provided additional support to GeoVax's vaccine development program in the form of a $15 million IPCAVD grant awarded in October 2007.

PRNewswire-FirstCall, http://biz.yahoo.com


u. Effectiveness of Second-Line Therapy

February 8, 2008

Better drugs and improved care means that second-line anti-HIV therapy now has a good chance of offering long-term control of viral load.

Researchers pooled information obtained from 22 cohort studies from around the world.

This analysis showed that soon after potent antiretroviral therapy became available in 1996 – 97 the incidence of virological failure during second-line therapy was 114 cases per 100 person years. This fell to 42 cases per 100 person years in 2000 – 2001. By 2004 – 2005, the rate of second-line treatment failure had fallen to just 15 cases per 100 person years.

But despite these advances in controlling viral load with second-line anti-HIV therapy, the researchers found that the risk of death for patients whose second-line treatment failed remained unaltered between 1996 – 2005.

www.aidsmap.com

v. Lymphomas

January 8, 2008

A study has looked at the risk factors for lymphomas in patients taking anti-HIV treatment.

German researchers found two main risk factors: having a detectable viral load, which increased the risk of Burkitt or Burkitt-like lymphomas; and having a CD4 cell count below 200 cells/mm3 increased the risk of non-Hodgkin’s lymphoma.

It is therefore very important that patients receive treatment with the aim of suppressing viral load to the lowest possible levels, said the researcher who conducted the study.

www.aidsmap.com


w. Treatment to Prevent Mother-To-Child Transmission

January 8, 2008

Treating HIV-infected mothers with tenofovir and FTC (emtricitabine) for a week after labour in addition to single-dose nevirapine during labour is safe and helps prevent the transmission of nevirapine-resistant virus to babies.

A study presented to CROI included 38 HIV-positive mothers in Africa and Asia. All the women received AZT from the 28th week of pregnancy to prevent mother-to-child transmission. During labour they also received a single dose of nevirapine as well as tenofovir and FTC. They then received a week of treatment with tenofovir and FTC. Their infants received nevirapine at birth and AZT for the first week of life.

This treatment produced big drops in the mothers’ viral load. None of the infants were infected with drug-resistant virus.

About a quarter of the women experienced side-effects, and adverse events were observed in a similar proportion of infants. But it is likely that many of these were unrelated to the use of anti-HIV drugs.

www.aidsmap.com

y. Children Infected With HIV from Pre-Chewed Food

January 8, 2007

Three children in the US have been infected with HIV after been given pre-chewed food. The food had blood on it from the mouth of the adult caregiver.

HIV-positive caregivers are being warned not to give pre-chewed food to children.

In resource-limited countries pre-chewing of food is common because of a lack of prepared baby food, so pre-chewing may pose a greater risk where there is a high prevalence of HIV and oral health is poor.

www.aidsmap.com

y. Herpes and HIV Transmission

January 8, 2008

Providing anti-herpes treatment to women lowers HIV viral load in both blood and vaginal secretions, a study conducted in Peru shows.

The study involved 20 women who were infected with both HIV and genital herpes (HSV-2). Half the women were given the anti-herpes drug valaciclovir to take every day, the other ten women were given a placebo.

Results showed that valaciclovir reduced HIV viral load in both the blood and in vaginal fluids. It also reduced the shedding of HSV-2.

And a study conducted amongst gay men in the US showed that HIV-positive gay men with HSV-2 were 16 times more likely to pass on HIV to their partner if their partner did not have genital herpes. Suppressing HSV-2 in HIV-positive men could, therefore, reduce the risk of HIV transmission.

These studies come after trials showed that providing anti-herpes treatment did not reduce HIV infections in men or women.

www.aidsmap.com


z. Gene Therapy Offers AIDS Hope

February 09, 2008

Scientists believe they may have pioneered a way to make the HIV/AIDS virus slow its reproduction, and potentially even self-destruct.

For the first time, researchers have slowed and possibly stopped the AIDS virus from reproducing in patients by using a gene therapy that tricks it into destroying itself, reported wire service MCT.

The results, announced on Wednesday, are heartening not just for people infected with HIV but also for the field of gene therapy, which remains highly experimental more than 20 years after scientists figured out how to use viruses to insert therapeutic genes into a cell's genome.

Mostly, the results are a big step forward for the biotech start-up that is developing the novel therapy and for its collaborators at the University of Pennsylvania.

"The buzzword in the field is viral 'fitness', meaning how well the virus can replicate," said Gary McGarrity, executive vice-president for scientific affairs at Virxsys Corporation, in Gaithersburg, Maryland.

"In eight of the nine patient samples we studied, we see diminished HIV fitness up to two years after treatment."

That raises the hope that even if medical science cannot come up with the holy grail of AIDS research -- a vaccine to prevent HIV infection -- patients may be able to keep HIV under control, perhaps without relying on the toxic drug cocktails that commuted what was once a death sentence.

"I think the Virxsys report is very important," said John Rossi, a molecular biologist at the City of Hope in California, who is also working on a gene therapy treatment for HIV.

"A lot of HIV patients are over 60 now and they're suffering the consequences of these toxic drugs. This shows there are alternatives."

The field of gene therapy has suffered years of missteps and controversy -- notably the 1999 death of Arizona teenager Jesse Gelsinger in an unrelated gene therapy experiment at Penn.

"I think the field is really starting to accelerate," said physician Carl June, who leads the Penn team that is collaborating with Virxsys. "There was so much frustration for years. But now there are new breakthroughs."

The latest gene therapy, called VRX496, is still in early human testing intended to demonstrate safety and determine the best dosages.

Of the 54 patients who have been treated so far in the ongoing clinical trial, none have experienced serious side effects, and many have seen clinical signs of effectiveness -- their HIV viral loads have fallen and their supply of infection fighting T cells has grown.

A Penn patient, one of the first and sickest to be treated, remains well more than four years later - even though conventional cocktails of anti-retroviral drugs had stopped working for him.

Wednesday's report, presented by Virxsys at a conference in Boston, looked deep into the molecular level of blood samples from nine randomly chosen patients to see whether the therapy was hitting its target.

VRX496 capitalises on the fact that viruses are impotent on their own but powerful inside a cell. That is the only place they can replicate, by hijacking the host's molecular machinery. HIV seizes control by splicing its own genes into the DNA of infection-fighting T cells, the backbone of the immune system.

The genetic wizardry involved in outwitting HIV is complex. First, the researchers remove T cells from an HIV patient and insert into those cells a gene that stops the AIDS virus from reproducing. Then, using Penn's patented technology, the T cells are multiplied a hundredfold and put back into the patient.

The vehicle, or "vector", that is used to insert this protective gene into the T cells is novel in itself: a disarmed version of HIV.

The gene carries instructions that eliminate the HIV virus' ability to wrap its DNA in an armoured shell. So when HIV invades the T cell, it steals this new armour-making gene, escapes from the cell - and then finds itself unable to make the shield it needs to break into more cells.

The latest study also found that the inserted gene is a double-whammy for HIV. The virus tries to simply delete the gene -- its favourite mutating tactic for becoming resistant to current drugs -- but that, too, reduces its reproductive "fitness." (It gets "wimpy", to use Dr June's word.)

The researchers found that blood samples from the nine cases presented yesterday were in fact loaded with the virus, most of it having mutated into harmless forms.
"For HIV to mutate around our treatment, it has to commit suicide," said Mr McGarrity, the Virxsys executive.

If this gene therapy becomes an approved treatment, still years away, the estimated cost for the one-time series of infusions would be $US130,000 ($A146,000), said Riku Rautsola, Virxsys' chief executive. While that's a hefty sum, the lifetime cost for conventional HIV-fighting drugs is about $US700,000 ($A785,000).

"We hope (VRX496) will become a frontline therapy once we have proven the impact is durable," Rautsola said. "This would clearly be better in terms of quality of life for the patients."

http://www.news.com.au/heraldsun

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Links of Interest

Death March

February 10, 2008


Gideon Mendel/Corbis
An HIV-positive mother takes her medication, Lusikisiki district, 2004.

Sizwe’s Test: A Young Man’s Journey Through Africa’s AIDS Epidemic.
By Jonny Steinberg, published by Simon and Schuster

No matter how serious a disease may be, devising a cure or treatment or ways of prevention is only half the battle. The other half can be more mysterious. Throughout the world, people who should know better eat, drink or have sex in needlessly risky ways, or ignore medical danger signs until it is too late. These, the willful ignorers, are what interest the South African journalist Jonny Steinberg about the gravest medical crisis his country has experienced: AIDS. More than one out of every eight South Africans is HIV positive, Steinberg reports; every day roughly 800 South Africans die of AIDS and more than 1,000 additional people are infected. A recent survey found that in the previous month, the average South African was more than twice as likely to have been to a funeral as to a wedding.

Pushed hard by a determined citizens’ movement, the South African government has at last begun widely distributing antiretroviral drugs. Why, Steinberg asks in "Sizwe’s Test," do so many people dying of AIDS not take them? And why do millions of South Africans at risk not even get tested for the virus?

To answer these questions, Steinberg, a Johannesburg newspaper columnist who has written several previous nonfiction books, focuses on Lusikisiki, a district in the country’s Eastern Cape Province. It is one of the overcrowded black rural slums left behind by the centuries in which white farmers seized well over 80 percent of South Africa’s most fertile land. Almost one out of three pregnant women in Lusikisiki was HIV positive, but the area also had a first-rate AIDS treatment program: well-stocked clinics run in cooperation with the local health authorities by the respected Médecins Sans Frontières. It seemed the perfect place to study.

Steinberg presents the district largely through the eyes of one man, whom he calls Sizwe Magadla. Sizwe is 30, healthy and literate; as the owner of a small shop, he is a rare mover and shaker in a community with high unemployment, where most people are struggling just to get by. Reasonably sophisticated about medicine, Sizwe knows that antiretrovirals are the best AIDS treatment so far, and he actually urges a sick relative to get tested. But despite being at risk himself — he has had unprotected sex with many women before recently settling down with one — he refuses to take an HIV test. He becomes both Steinberg’s window onto Lusikisiki and an object of study himself.

Steinberg unfolds the story in a leisurely, almost rambling way, in successive layers, as he gets to know Sizwe and the community’s complex social network. The first layer has to do with the extreme lack of privacy. In Lusikisiki, everyone knows exactly who’s sleeping with whom: houses are small and packed with several generations of curious relatives, and even when a couple try to find some space of their own, dozens of pairs of eyes see them disappearing into the forest together. And if you get your HIV test results at one of the clinics, hundreds of your fellow villagers are waiting in line behind you. If you immediately leave the nurse’s office and go home, they know you’re HIV negative; if you’re kept behind for an hour of counseling, they know you’re positive.

The next layer down has to do with fear. Although he doesn’t yet have enough money for a car, Sizwe is relatively prosperous and worries about the envy of his fellow villagers since he has made his money from them. Not only that, but a rival shopkeeper with connections to a criminal gang has his eye on Sizwe’s business. He fears any sign of weakness or vulnerability could lose him customers or get him robbed.

But there’s an even deeper level to people’s resistance to testing and treatment. As with many indigenous peoples — I’ve encountered the same belief among Indians in the Amazon — the Xhosa people of Lusikisiki see sickness as a kind of bewitchment, something sent to you by ancestors you have offended or by those who wish you ill. If whites already took so much farmland and mineral wealth, the thinking goes, could not the very needle the white doctor or his nurses use to draw blood be what’s spreading AIDS in the first place? And if an enemy does attack you, what more deadly way than with an illness that seems connected to a man’s potency and ability to procreate? Men are anxious about these things the world over, but nowhere more so than when, in desperate poverty, they possess little else.

Although Steinberg writes in the first person, he largely keeps himself out of the story until about 30 pages from the end. And then, before returning to Sizwe again, he suddenly shares some intimate pieces of his own life. I will not spoil the effect of this forceful narrative twist by telling more, except to say that it greatly helps to etch the final layer he uncovers. This has to do with the immense power of stigma, the ways in which we mirror the real or imagined condemnation of others by internalizing it, and of how easily stigma becomes entwined with sexuality.

For all its sharp insights and value, "Sizwe’s Test" has one serious flaw. Steinberg devotes only a perfunctory few pages to Thabo Mbeki, South Africa’s president since 1999 and powerful deputy president for five years before that. Mbeki long denied that the HIV virus causes AIDS, embracing a small coterie of similarly-minded crackpot scientists and appointing a health minister who promoted, as a cure, the use of garlic, olive oil and various herbs. Drawing outrage from AIDS activists everywhere, these bizarre beliefs delayed the large-scale distribution of antiretroviral drugs year after precious year. Hundreds of thousands of South Africans who have died of AIDS might still be alive today if Mbeki had repeatedly spoken out about safe sex and AIDS testing and treatment, and had thrown the full weight of his ruling party apparatus behind such a campaign. Several other African leaders, most notably President Yoweri Museveni of Uganda, have done just this and have saved countless lives as a result. If Mbeki had been shown on TV getting an AIDS test, I bet Sizwe would have gotten his.

To play down Mbeki’s stubborn obscurantism in a book about AIDS in South Africa is like writing a book about Americans and global warming while ignoring seven years of stubborn obscurantism on that subject from the White House. It is precisely when folk beliefs, fear and stigma attached to serious illness are most deeply rooted, in the way Steinberg shows so well, that forceful truth-telling by a country’s leaders becomes most important to create a sea change in long-established attitudes and habits. The failure of leadership in South Africa has been a great tragedy for a long-suffering people who deserve better.

By Adam Hochschild, The New York Times
Adam Hochschild is the author of six books; his "Mirror at Midnight: A South African Journey" was reissued by Houghton Mifflin last year in an updated edition.

http://blogs.poz.com/david/archives/2008/01/hot_metal_hubri.html

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