Atlanta Tenofovir Study Aimed at Determining if Drug Can Prevent HIV Infection Begins Enrolling MSM
The Atlanta arm of a CDC-funded study aimed at determining if Gilead's antiretroviral drug Viread is effective at preventing HIV infection has begun enrolling men who have sex with men, the Atlanta Journal-Constitution reports (Wahlberg, Atlanta Journal-Constitution, 3/17). CDC granted $3.5 million to fund trials in San Francisco and Atlanta to test FDA-approved Viread, which is known generically as tenofovir and has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals. The trials are designed to determine if Viread is safe to use for HIV prevention among MSM and if using the drug would result in an increase in unsafe-sex practices and higher HIV incidence. If any of the participants contract HIV while taking Viread, researchers can determine whether the strain they contract is resistant to the drug. In each city, researchers plan to enroll 200 MSM in the double-blind study. Participants will be assigned to take Viread or a placebo every day for two years (Kaiser Daily HIV/AIDS Report, 12/2/04). The Atlanta study -- which began last month at the AIDS Research Consortium of Atlanta and seeks to enroll 100 black MSM -- so far has enrolled five people in the study, according to the Journal-Constitution.
Other Tenofovir Studies
Similar tenofovir trials in other countries recently have been stopped or have "run into snags," the Journal-Constitution reports (Atlanta Journal-Constitution, 3/17). The Bill & Melinda Gates Foundation last year awarded a $6.5 million grant to Family Health International 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. However, Cameroon's Ministry of Health last month announced its arm of the trial, which involved HIV-negative commercial sex workers in the city of Douala, was suspended after ACT UP/Paris alleged that the trial violated ethical norms and called for its cancellation. However, FHI denies ACT UP/Paris' claim and is addressing all of the ministry's concerns and recommendations regarding the trial. FHI on Monday announced that it had cancelled the Nigerian arm of the trial of HIV-negative commercial sex workers because of a failure of local researchers to reach necessary scientific standards. In addition, Cambodian Prime Minister Hun Sen in August 2004 ordered an end to a planned trial of the drug in commercial sex workers because of the possible effects of the drug on trial participants. About 150 Cambodian members of the Women's Network for Unity had said they would not participate in the study unless they were provided with 30 years of health insurance to cover possible adverse reactions and side effects from taking the drug. HIV/AIDS advocates in Bangkok, Thailand, on Thursday also raised questions about the safety and transparency of a CDC-funded, three-year clinical trial of tenofovir in Bangkok, which is scheduled to begin next month (Kaiser Daily HIV/AIDS Report, 3/16).