Cameroon Health Ministry Suspends Clinical Trial Testing Tenofovir for HIV Prevention
The Cameroon Ministry of Health on Thursday announced that it has suspended a "controversial" 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, AFP/Cameroon-info.net reports. Health Minister Urbain Awono said that the trial, which involved commercial sex workers in the city of Douala, was suspended for "failings in their implementation," according to AFP/Cameroon-info.net. In a demonstration last month outside the Cameroon embassy in Paris, members of ACT UP/Paris asked that the trial be halted for running "counter to ethical norms," AFP/Cameroon-info.net reports. ACT UP/Paris claims that Gilead, which manufactures Viread, recruited "particularly vulnerable" commercial sex workers for the trial without providing HIV/AIDS prevention programs or treatment (AFP/Cameroon-info.net, 2/3). 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 Family Health International 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, 12/22/04).
Awono said, "The suspension will remain until the promoter of the trial shows proof that the commitments made in their agreement are rigorously respected and all conditions of their effective implementation are satisfactory." The decision to suspend the trial came after a commission of doctors recently delivered a report on how the trial was being conducted, according to AFP/Cameroon-info.net (AFP/Cameroon-info.net, 2/3). FHI in a statement said that it "is committed to addressing all concerns identified in the ministry's careful review of the tenofovir study," including recommendations to revise administrative procedures and boost local partnerships with HIV/AIDS prevention and control associations to assist participants who become HIV-positive during the trial. The statement said, "As we work with our local partners to address the ministry recommendations regarding the mainly administrative issues raised, the safety and welfare of the study participants remains our highest priority -- therefore resuming the study as soon as possible is extremely important" (FHI release, 2/4).