JOHANNESBURG, SOUTH AFRICA—Nearly four years after political pressure shut down two trials that would have tested whether a once-a-day pill could prevent high-risk HIV-negative people from catching the AIDS-causing virus, there’s a surge of renewed interest in the concept, known as Pre-Exposure Prophylaxis, or PrEP.

Western doctors and organizations that funded the halted trials of the anti-HIV drug tenofovir in Cameroon and Cambodia say they've learned their lesson from the debacle in 2004 and 2005, when activist groups questioned the quality of medical care impoverished study participants would receive if they suffered side effects or the became infected by HIV. Today, with at least seven U.S.-funded PrEP trials underway at a cost of $39.5 million, researchers are working with local advocates, who have traditionally been distrustful of Big Pharma, to push the studies forward.

"The whole prevention community really had a wake-up call," says Linda-Gail Bekker, an infectious disease researcher at the University of Cape Town’s Desmond Tutu HIV Center, who is running the South African study site for a new PrEP trial that will eventually involve at least 3,000 gay men in South Africa, Asia, South America and the U.S. The study, which is enrolling trial participants now, is being funded by the U.S. National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. Its first results are expected in 2010.

In August 2004, Cambodian Prime Minister Hun Sen stopped a trial of PrEP on prostitutes in his country under pressure from activists who said the study was exploiting vulnerable trial participants. Cameroon, which was to be part of a larger, three-country western Africa PrEP trial, shut the trial there down in early 2005 after questions were raised about the trial’s health care provisions for participants.

PrEP researchers now acknowledge they made a mistake by not involving local advocates from the start. After years of being told that antiretroviral drugs were toxic, the idea of using them in uninfected people seemed reckless to many. Local activists, along with their international supporters, believed the trials were being run by profit-hungry pharmaceutical companies who were coming to poor countries to do dangerous research that would later pad their own pockets and only end up benefiting people in the developed world.

In fact, the trials were being conducted by university and nonprofit researchers, and funded by the U.S. government and the Bill & Melinda Gates Foundation. Gilead Sciences, Inc., tenofovir's maker, provided the drugs for free but was otherwise not involved in the trial. And the drug's safety had already been proved in previous HIV treatment trials—many of them conducted in the U.S.

“I don’t think there was some wild, unethical conduct,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, which has helped facilitate dialogue on PrEP issues. “But there was a little defensiveness and a lot that got lost in translation.”

ACT UP/Paris, which is part of the international AIDS awareness activist coalition and was involved in the Cameroon controversy, and the Treatment Action Campaign (TAC), South Africa's largest organization of people with AIDS, have been involved in new trials from their earliest stages. New guidelines have also been written setting standards for community involvement in prevention trials, which recommend, for example, that researchers hold meetings with communities prior to the beginning of new trials to address what health care will be provided to participants.

11 Comments

1. 1. hotblack 10:37 AM 12/1/08

   "Natures methods of keeping populations from exploding beyond their means is disease and famine."
   
   Hmmm.

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2. 2. clathrate 02:09 PM 12/1/08

   Leave it to a french AIDS organization to shut down trials of a lifesaving HIV drug.

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3. 3. Assegai 04:42 PM 12/1/08

   that would be nice, but there are not too many people in Africa, there is underdevelopment, that Aids appeared after whites said there are too many blacks is frightening what kind of evil is that

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4. 4. Assegai 04:45 PM 12/1/08

   that would be nice, but there are not too many people in Africa, there is underdevelopment, that Aids appeared after whites said there are too many blacks is frightening what kind of evil is that, at least today people understand with knowledge the earth can accommodate more people, the only people who will remain in the past are the Canadians, to them only whites have brains, that is why Aids will be beaten because most humans try to be progressive

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5. 5. Ms. Rodessa 05:51 PM 12/1/08

   Many man made and natural plagues have ravaged this world; and those who are left standing are the ones who were meant to be...even after the pilgrams voyage the children were the only strong ones to lead..HIV is just a disease and it will be replace by one more seriouse than it* How can we say one race will supperceed another...How long has mankind been trying to erase each other...now the this world is small er will all be erased and no one will be able to tell what happend how it happened or when it happened ....WHY ? the answer is ; because no one will be here to write the History of the great extection of the animal that walked on two legs that feed the world with knowledge and used machanical angles in space to talk to one another. Nobody but Dirty Illiterate two legged creatures that resemble the being that walked on two legged that feed the world food and knowledge.

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6. 6. JimPickett in reply to Ms. Rodessa 06:24 PM 12/1/08

   Two points of clarity -
   
   Microbicides are being developed for use by both men and women, to be applied vaginally or rectally.
   
   It is a stretch to say that the majority of the transmission in Africa is heterosexual --- many countries in fact do not even report data on gay men and other men who have sex with men.

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7. 7. Ms. Rodessa 07:15 PM 12/1/08

   everybody is having sex so anybody can get it so wake up and use the modern medicine that was created for a disease created by modern means; I live smart people and I hope they can pull this one off and sell it to everybody or give it like a polio prevention.

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8. 8. Ms. Rodessa 10:46 AM 12/2/08

   Fresno, California should be the place to use this drug in fact the State Prisons have need of this... Our Highs Shcools here have a high percentage of youth infected with HIV; maybe the schools can have this type of information as a Class for future Scientist of America, class for those who are interested in Medicine.
   We leave our children in the dark too long and when they need answers it's because they already have the problem...We can not stop behavior but we can sure make smart choices if we have a little more knowledge*

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9. 9. Ms. Rodessa in reply to Ms. Rodessa 12:18 PM 12/3/08

   I wonder is this a racial thing**** I hope not. Saving a life could be your own life.
   Ignorace is like this HIV it is a choice is most cases, like Education is...Are we burning books again...I do hope the studies will be revived for the hope of all living beings than reside on Planet Earth.
   The well known story of, "Noahs Ark" if you ever read it... nobody jumped off the boat and it must have gotten pretty sticky but in the end they all arived safe and lived to tell the story* animals and all. Maybe not the wookpecker* but they all got ashore...this thing is bigger than we are and we need to stay in the boat together and work on it together. We maybe be asking ourselves; "what ever happend to whats his name or her name"

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10. 10. jpuah23 01:34 PM 12/7/09

    There are many natural ways to rid your body of HIV. In contrast with the traditional antiviral cocktails of medicine today, which cost thousands, have severe side effects, and comes with the double edged sword delema,meaning if the virus doesn’t kill you the cocktails will, this medicine is all natural.Please visit this site for the full information about this subject……http://pushgood-nomorehiv.blogspot.com/

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11. 11. jpuah23 01:35 PM 12/7/09

    There are many natural ways to rid your body of HIV. In contrast with the traditional antiviral cocktails of medicine today, which cost thousands, have severe side effects, and comes with the double edged sword delema,meaning if the virus doesn’t kill you the cocktails will, this medicine is all natural.Please visit this site for the full information about this subject……http://pushgood-nomorehiv.blogspot.com/

    Reply | Report Abuse | Link to this