Washington Post Examines Cancellation of Cambodian Trial Testing Tenofovir’s Efficacy To Prevent HIV Transmission

The Washington Post on Tuesday examined the circumstances that led to the cancellation in August 2004 of a human clinical trial that planned to test the efficacy of Gilead's antiretroviral drug Viread -- known generically as tenofovir -- to prevent HIV transmission, as well as the effect of the cancellation (Eunjung Cha, Washington Post, 5/23). Viread has been shown to boost immune response and reduce viral levels in the bloodstreams of patients who are resistant to other antiretroviral drugs. NIH in March 2004 awarded a $2.1 million grant to University of California-San Francisco researchers to test Viread in 960 Cambodian women, most of whom are commercial sex workers. The yearlong study, which also was funded by the Bill & Melinda Gates Foundation, was to be a collaborative effort between Cambodia's Ministry of Health, UCSF and the University of New South Wales. However, about 150 Cambodian commercial sex workers who are members of the Women's Network for Unity said they would not participate in the study unless they were provided with 30 years of health insurance to cover treatment for possible adverse reactions and side effects from taking the drug (Kaiser Daily HIV/AIDS Report, 8/12/04). According to the Post, some of the sex workers also asked for higher pay and more information about the trial. UCSF researcher Kimberly Page Shafer, one of the lead researchers in the study, said some of the sex workers' requests were attended to, including a plan to set up a clinic to treat any participant who contracted HIV. However, Cambodian Prime Minister Hun Sen in August 2004 ordered a stop to the proposed trial, citing a concern for "human values and rights."

Effect of Cancellation
According to the Post, the "negative reaction" to the proposed trial was "further fueled" by false "rumors," including that the pills contained HIV, that tenofovir was not being tested in the U.S. and that researchers were encouraging participants not to use condoms. After the trial was canceled, HIV/AIDS advocates "began turning against each other," with some advocates saying that the groups Womyn's Agenda for Change and ACT Up-Paris, both of which advised the Cambodian sex workers, were "slowing research," the Post reports. However, Fabrice Piorge of ACT Up-Paris said the trials should have been better designed for the safety of the participants, adding that the protests were not brought in from outside Cambodia. Tenofovir trials also have been cancelled in Cameroon and Nigeria but trials continue in Botswana, Ghana, Malawi, and Peru, as well in Atlanta and San Francisco among HIV-negative men who have sex with men (Washington Post, 5/23).