Cambodian Sex Workers Refuse To Participate in Clinical Trial of Antiretroviral Drug Without Insurance for Side Effects
A group of Cambodian commercial sex workers has refused to participate in a clinical trial of the antiretroviral drug Viread to determine whether it can prevent HIV infection unless the trial's sponsors guarantee them health insurance for 30 years to treat possible side effects caused by the drug, the AP/Seattle Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 3/29). NIH, CDC and the Bill & Melinda Gates Foundation are funding three separate human studies of Viread, which is manufactured by Gilead Sciences and is FDA-approved for use as a treatment for HIV infection. The drug, which is known generically as tenofovir, has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals. The Gates Foundation has awarded a $6.5 million grant to Family Health International to conduct a randomized, placebo-controlled clinical trial to evaluate whether Viread is effective at reducing the risk of HIV infection. The trial will include 2,000 volunteers in Cambodia, Ghana, Cameroon, Nigeria and Malawi.
NIH has awarded a $2.1 million grant to University of California-San Francisco researchers to test Viread in 960 Cambodian women, most of whom are sex workers (Kaiser Daily Reproductive Health Report, 2/6). The year-long Cambodian study, which is expected to begin in June, will be a collaborative effort between Cambodia's Ministry of Health, UCSF and the University of New South Wales in Australia, according to the AP/Post-Intelligencer. However, about 150 sex workers belonging to the Women's Network for Unity have said they will not participate in the study unless they are provided with 30 years of health insurance to cover possible adverse reactions and side effects from taking the drug (AP/Seattle Post-Intelligencer, 3/29). "They said that they don't want to try the drug because they are poor and they are sex workers," WNU President Kao Tha said, adding, "They said if (they) fall ill, who will look after their mothers, children, sisters or brothers?" (AP/Las Vegas Sun, 3/26). Kimberly Page Shafer, a UCSF professor, said that the drug's side effects, which include stomach gas and nausea, are "not serious," according to the AP/Post-Intelligencer. Although the participants will be provided with medical care during the course of the trial, providing them with insurance for 30 years would be "impossible," Page Shafer said. She added, "There's probably no place in the world where women in clinical trial[s] have access to coverage for life." Cambodia was selected for the trial because the country has the highest HIV prevalence in Southeast Asia, according to the AP/Post-Intelligencer. However, the country's HIV prevalence decreased from 3.8% in 1997 to 2.6% in 2002 (AP/Seattle Post-Intelligencer, 3/29).