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Cameroon Health Ministry Agrees to Resume Viread Trial; FHI to Help Participants Infected During Study Find Treatment

February 24, 2005

Cameroon's Ministry of Health over the past few days has agreed to resume a clinical trial that is testing the antiretroviral drug Viread, known generically as tenofovir, to determine if it can reduce the risk of HIV infection, the Financial Times reports (Jack, Financial Times, 2/23). The health ministry earlier this month announced that it had suspended the trial, which involved HIV-negative commercial sex workers in the city of Douala, after the advocacy group ACT UP/Paris alleged that the trial violated ethical norms and called for it to be stopped. ACT UP/Paris claims that Gilead, which manufactures Viread, recruited particularly vulnerable participants for the trial without providing HIV/AIDS prevention information or treatment. Dr. Ward Cates, president of Family Health International's Institute for Family Health, which is conducting the study, flew to Cameroon to try to salvage the trial and denied ACT UP/Paris' claims that the study is unethical (Kaiser Daily HIV/AIDS Report, 2/8).

FHI Addressing Concerns
The health ministry last week agreed that FHI could conduct follow-up study on participants already enrolled in the study "without interruption," a decision that FHI said would "help ensure the health and well-being of the women who have volunteered to take part in this important study," according to an FHI release (FHI release, 2/22). FHI has pledged to find ways to guarantee antiretroviral treatment to participants who become infected with HIV during the clinical trial, according to the Times (Financial Times, 2/23). The group said that it is "addressing all concerns" raised by the health ministry and is making "significant progress" in implementing the ministry recommendations, including revisions to administrative procedures and augmenting local partnerships with HIV/AIDS prevention and control organizations to provide better counseling and support for trial participants, according to the release (FHI release, 2/22).

Reaction
Cates said that he has "never been involved in a trial that has gone to such lengths" to meet or exceed "current best practice," according to the Times. He added that most prevention studies do not guarantee treatment to participants who are infected during the study and that such a guarantee could amount to a "research bribe" to induce people to participate, which would be against medical ethics, according to the Times. The latest ethical guidelines from the Council for International Organizations of Medical Sciences states that clinical trial sponsors are not obligated to provide follow-up treatment to participants but that providing treatment is "morally praiseworthy." Juhana Idanpaan-Heikkila, secretary general of the council, said that the Cameroon case highlights an ongoing ethical debate over clinical trials, according to the Times. "It's a contested issue, but my personal view is that you should have to provide treatment," Idanpaan-Heikkila said. Gilead said that if Viread can reduce the risk of HIV infection, it will provide the drug at cost in developing countries, the Times reports (Financial Times, 2/23).

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