Antiretroviral Drug Researchers, AIDS Advocates To Meet To Discuss Concerns Over Viread Trials in Developing Countries
Antiretroviral drug researchers, study sponsors and AIDS advocates on Thursday are scheduled to attend a meeting in Seattle sponsored by the International AIDS Society to attempt to settle a dispute over how clinical trials testing whether Gilead's antiretroviral drug Viread can prevent HIV infection are conducted in developing countries, the Wall Street Journal reports. 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, according to the Journal. In addition, some AIDS advocates want injection drug users participating in the 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, according to the Journal. The debate has "throw[n] a spotlight on the gap in care between rich and poor countries," and the "gulf" between the two sides in the dispute "may be too wide for any quick fix," the Journal reports.
At the meeting, members of ACT UP/Paris and patient advocates will meet with representatives of the Bill & Melinda Gates Foundation, NIH and CDC -- all of which are funding the studies -- to seek "common ground" on how the trials can be conducted in an ethical manner, according to the Journal. The studies' sponsors say they have tried to improve local clinics and have trained more personnel to provide future care to people who might become HIV-positive during the study period, but they argue that these "high hurdles" could "stunt" their studies' progress, according to the Journal. Researchers originally hoped to have completed the trials by as early as 2006, but they now do not expect results before 2007, the Journal reports (Chase, Wall Street Journal, 5/18).