Protests Might Slow Trials Aimed at Determining if Antiretroviral Drug Viread Could Prevent HIV Infection
Protests from AIDS advocates over international trials aimed at determining if Gilead's antiretroviral drug Viread is effective at preventing HIV infection could delay what CDC says is "one of the most important new prevention approaches being investigated today," the San Jose Mercury News reports (Johnson, San Jose Mercury News, 6/13). 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 men who have sex with men 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 contracted is resistant to the drug. In each city, researchers plan to enroll 200 MSM in the double-blind study, in which participants will be assigned to take Viread or a placebo every day for two years (Kaiser Daily HIV/AIDS Report, 3/18). Public health officials in San Francisco began recruiting MSM for the trial in February. The trials are an "exciting prospect," Albert Liu of the San Francisco Department of Public Health, who is overseer of the trials, said, adding, "Because tenofovir is an approved drug, it's something we could get more quickly into the field" (San Jose Mercury News, 6/13).
Similar tenofovir trials in other countries recently have been stopped or have run into problems. 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, because the trials are funded with U.S. money, providing clean needles would breach a congressional ban on the practice. Researchers, study sponsors and AIDS advocates last month met in Seattle to discuss advocates' concerns, but they failed to completely resolve conflicts over the provision of lifelong antiretroviral treatment (Kaiser Daily HIV/AIDS Report, 5/24). "I don't think the way the concerns were raised by certain groups, including ACT UP/Paris, was appropriate," Mark Harrington, executive director of the Treatment Action Group, said. ACT UP/Paris representatives could not be reached for comment, according to the Mercury News (San Jose Mercury News, 6/13).