Thai HIV/AIDS Advocates Oppose Government Plan To Host Clinical Trial Testing Tenofovir for HIV Prevention
Thai HIV/AIDS advocates on Thursday expressed their opposition to a government plan to host a clinical trial scheduled to begin next month in Bangkok, Thailand, to test Gilead's antiretroviral drug Viread to determine if it can reduce the risk of HIV infection, the Bangkok Post reports (Apiradee, Bangkok Post, 3/11). The drug, which is known generically as tenofovir, works by blocking HIV's reverse transcriptase enzyme to prevent replication. Tenofovir is FDA-approved for use as a treatment for HIV infection and has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals. The CDC-funded, three-year clinical trial, which has been approved by Thailand's Ministry of Public Health, will be conducted in the city by the Bangkok Metropolitan Administration at Taskin Hospital, BMA Deputy City Clerk Pitinan Natrujirote said. About 1,600 volunteers, including injection drug users and other people at high risk of contracting HIV, will be recruited to participate in the trial, Pitinan said (Kaiser Daily HIV/AIDS Report, 3/9).
HIV/AIDS advocates have "raised questions about the trial's safety and transparency and possible human rights violations," and several groups said the plan does not allow them to express their position, according to the Post. "We can't accept this drug trial. Authorities do not allow people living with HIV/AIDS to get involved in project planning or learn about pros and cons even though we have a right to do so," Nimit Tienudom, director of the AIDS Access Foundation, said. "Community participation should be treated as an essential element of any clinical study," Suphatra Nakapiew, director of the Human Rights on AIDS Protection Centre, said, adding, "Drug users, NGOs and activists should be involved from the outset on any official committee, not just as public participants who join after all the protocols have been accepted" (Bangkok Post, 3/11). Seree Jintakanon, chair of the Thai Drug Users' Network, also criticized the trials for not agreeing to provide treatment for participants discovered to be HIV-positive when applying for the trial or who contract the virus during the trial (AP/Long Island Newsday, 3/10). Seree asked researchers to use a "comprehensive harm reduction approach" and ensure the "same quality of referrals, support, treatment and care" that trial participants would be able to access through the public health care system, according to the Post.
Other Tenofovir Trials Face Controversy
Similar controversy has surrounded other trials involving tenofovir, the Post reports (Bangkok Post, 3/11). 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. In addition, Cameroon's Ministry of Health last month announced it had suspended the trial, which involved HIV-negative commercial sex workers in the city of Douala, after ACT UP/Paris alleged that the trial violated ethical norms and called for its cancellation. The group claims that the study recruited particularly vulnerable participants without providing HIV/AIDS prevention information or treatment. However, Family Health International, which is conducting the trial using funding from the Bill & Melinda Gates Foundation, denies ACT UP/Paris' claim that the study is unethical and is addressing all of the ministry's concerns and recommendations regarding the trial. The health ministry has agreed to allow the follow-up of participants currently enrolled in the trial (Kaiser Daily HIV/AIDS Report, 3/9).