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Nigerian Viread study called off

Nigerian Viread study called off

A U.S. organization running a clinical trial in Nigeria to test whether the anti-HIV drug Viread is effective in preventing HIV infections in high-risk populations has called off the study because of the failure of local researchers to meet international scientific standards, London's Financial Times reports. Family Health International this week called off the study that would have involved hundreds of sex workers at high risk for HIV infection. An FHI press release reads, "The ability to meet these standards is critical for ensuring the safety of participants and the quality of the data from the study." The release adds that there was no evidence that any of the HIV-negative sex workers involved in the trial were "harmed or put at risk as a result of the procedural problems at the Nigeria site" and that there were no serious medical problems related to giving the trial participants daily doses of the anti-HIV medication. Similar Viread preexposure prophylaxis studies have run into problems in Cameroon and Cambodia. Officials in Cameroon temporarily suspended a Viread trial there because of concerns that the female sex workers participating in the study weren't given adequate instruction on how to protect themselves from HIV and weren't guaranteed treatment if they became infected during the course of the trial. Cambodia's prime minister last year canceled a clinical trial in that country over similar concerns. Studies involving sex workers and injection-drug users are under way in Thailand, Malawi, and Ghana, and trials involving sexually active gay men are being conducted in San Francisco and Atlanta. The Nigerian health ministry said it was disappointed that the clinical trial was canceled but offered no additional comments. Nigeria is home to more than 3 million HIV-positive people.

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