Cameroon Government Suspends Viread Clinical Trial After ACT UP/Paris Protests; FHI Working To Resume Study

Cameroon's Ministry of Health on Thursday announced that it has suspended a clinical trial that is testing the antiretroviral drug Viread, which is known generically as tenofovir, to determine if it can reduce the risk of HIV infection, after the advocacy group ACT UP/Paris claimed that volunteers in the study "got too little information and care for their participation," the Wall Street Journal reports. Dr. Ward Cates, president of Family Health International's Institute for Family Health, which is conducting the clinical trial, flew to Cameroon on Monday to try to "salvage" the trial and denied ACT UP/Paris' claims that the study is "unethical," according to the Journal (Chase, Wall Street Journal, 2/8). In a demonstration last month outside the Cameroon embassy in Paris, members of ACT UP/Paris asked that the trial, which involved HIV-negative commercial sex workers in the city of Douala, alleged that the trial violates ethical norms and called for it to be stopped. ACT UP/Paris claims that Gilead, which manufactures Viread, recruited particularly vulnerable CSWs for the trial without providing HIV/AIDS prevention programs or treatment. However, Cameroon Health Minister Urbain Awono in a statement said that the trial was approved in January 2003 "after a long verification process ensuring that all ethical principles governing research involving human beings are respected." He added that the trial will be suspended until FHI "shows proof that the commitments made in their agreement are rigorously respected and all conditions of their effective implementation are satisfactory" (Kaiser Daily HIV/AIDS Report, 2/7). FHI in a statement said that the health ministry temporarily suspended the trial pending discussion and action on a number of primarily administrative recommendations made during a recent ministry review of the study. According to FHI, the ministry's recommendations "did not include any issues affecting the safety and well-being of the study participants or issues affecting the scientific integrity of the study (FHI release, 2/4).

Trial Details
NIH, CDC and the Bill & Melinda Gates Foundation are funding three separate studies of Viread. The drug is FDA-approved for use as a treatment for HIV infection and has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals. CDC has granted $3.5 million to fund trial sites in San Francisco and Atlanta, while the Gates Foundation awarded a $6.5 million grant to FHI to conduct a randomized, placebo-controlled clinical trial including 2,000 HIV-negative volunteers at sites in Cambodia, Ghana, Cameroon, Nigeria and Malawi (Kaiser Daily HIV/AIDS Report, 2/7).

Reaction
Cates said that many of ACT UP/Paris' claims "were just wrong," adding, "My concern is that suspension of the trial might mean closing the doors of the clinic." Cates said that all of the women involved in the trial gave informed consent and received counseling on HIV prevention in the presence of bilingual or trilingual patient advocates. In addition, any participant who is infected with HIV during the trial would be referred to one of Cameroon's HIV/AIDS treatment programs to receive antiretroviral therapy, according to Cates. Gilead, which has agreed to sell Viread at cost in resource-poor countries, said it hopes the study will resume, the Journal reports. Mark Harrington, director of the New York-based Treatment Action Group, said that ACT UP/Paris is practicing "ethical imperialism" by opposing the trial, adding, "It's not going to reduce HIV to stop the trial or provide health care to a single one of those sex workers in Cameroon" (Wall Street Journal, 2/8).