Antiretroviral Drug Researchers, AIDS Advocates Fail to Reach Consensus Over Viread Trials in Developing Countries

Antiretroviral drug researchers, study sponsors and AIDS advocates in a meeting that began last week in Seattle reached some agreement but failed to resolve completely conflicts over the conduct of clinical trials testing whether the antiretroviral drug Viread, which is made by the pharmaceutical company Gilead, can prevent HIV infection among people in developing countries, the Wall Street Journal reports (Chase, Wall Street Journal, 5/24). At issue is whether researchers should provide lifelong antiretroviral treatment -- not just a referral for care -- to people who become HIV-positive while participating in the trials. Protests organized by ACT UP/Paris and other European AIDS organizations demanding such care have led to the cancellation of Viread studies in Cambodia and the suspension of trials in Cameroon. However, researchers say that offering lifelong treatment to volunteers might violate a prohibition on undue inducement to participate in clinical trials. In addition, some AIDS advocates want injection drug users participating in a Viread trial in Thailand to be provided with clean needles. However, the trials are using U.S. funding, and providing clean needles would breach a congressional ban on the practice (Kaiser Daily HIV/AIDS Report, 5/18).

Meeting Outcome
At the meeting -- which was sponsored by the International AIDS Society -- patient advocates met with representatives of the Bill & Melinda Gates Foundation, NIH and CDC. Conferees agreed that trial volunteers should receive more HIV prevention counseling and barrier contraceptives, including female condoms. A report resulting from the meeting said efforts to counsel volunteers were sometimes "ill-informed and inconsistent," according to the Journal. However, the meeting did not resolve the dispute over the provision of lifelong antiretroviral treatment for people who become HIV-positive while participating in the studies. The conferees agreed that "mechanisms" to ensure treatment needed to be established, but they did not agree on the important question of who would pay for treatment, according to the Journal (Wall Street Journal, 5/24).

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