FHI Cancels Nigerian Arm Of Clinical Trial Testing Tenofovir For HIV Prevention

Family Health International on Monday announced that it has cancelled the Nigerian arm of an ongoing clinical trial testing Gilead's antiretroviral drug Viread because of a failure of local researchers to reach "necessary scientific standards," the Financial Times reports (Jack/Peel, Financial Times, 3/15). The Bill & Melinda Gates Foundation last year awarded a $6.5 million grant to FHI to conduct a randomized, placebo-controlled clinical trial of Viread including 2,000 HIV-negative volunteers at sites in Nigeria, Cambodia, Ghana, Cameroon and Malawi. The drug, known generically as tenofovir, is being tested to determine its effectiveness in preventing HIV transmission. Tenofovir, which is FDA-approved for HIV treatment, has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals (Kaiser Daily HIV/AIDS Report, 3/9). FHI cancelled the study because not all of the trial sites were able to comply with "rigorous internationally accepted standards," according to an FHI release. "The ability to meet these standards is critical for ensuring the safety of participants and the quality of the data from the study," according to the release. However, there is "no evidence" that any of the trial participants -- who were HIV-negative commercial sex workers -- "were harmed or put at risk as a result of the procedural problems at the Nigeria site" and there have been "no serious medical problems" related to tenofovir, according to FHI (FHI release, 3/11). Nigeria's Ministry of Health on Monday said that it was "disappointed" that the trial was cancelled but did not comment further, according to the Times.