HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia

Abstract

On Aug 13 2004 all work was stopped and never resumed on a study being prepared in Cambodia to determine whether daily oral tenofovir disoproxil fumarate was safe and effective in preventing the sexual transmission of HIV infection. The study was to have been a randomised double-blind trial that recruited 960 HIV-negative women engaged in sex work to receive either 300 mg of tenofovir disoproxil fumarate once daily or an identical placebo for 12 months. Trial development was suspended in response to a statement from the Cambodian Prime Minister. Before the statement concerns about the trial had been raised by a group representing women engaged in sex work in Cambodia. There has since been much commentary about the trial and its surrounding issues through the media and the internet. The commentary asserted that: the trial was purely motivated by the commercial interests of a pharmaceutical company the drug had not been adequately assessed before it was proposed as a possible prevention agent affected communities were inadequately consulted during study preparations the researchers would not be providing participants with safe sex counselling and condoms during the trial to increase HIV incidence recruitment practices would not adequately incorporate informed consent and medical treatment for trial-related injury and HIV care for seroconverters would not be available to participants. Along with this commentary the researchers were accused of engaging or intending to engage in practices that were inconsistent with the standards of research ethics. To better inform public discussion we provide our perspective on the design and development stages of the trial focusing particularly on issues raised by commentators. (excerpt)