Health in Action Moving Toward Assured Access to Treatment in Microbicide Trials

Abstract

Public concern about ethics in HIV-prevention trials intensified in the last 18 months, reaching a flashpoint that resulted in the halting of two clinical trials to test the efficacy of tenofovir as a possible method of pre-exposure prophylaxis (PREP) against HIV infection. A reverse transcriptase inhibitor, tenofovir is viewed as a promising candidate for PREP because it is already being widely used as a component in combinationtherapy regimens to suppress viral replication, it has a once-daily dosing schedule, and clinical trials have shown a low level of side effects [1]. Six randomized, placebo-controlled trials to test tenofovir among highrisk populations have been planned to date. Two of these were halted by government order of the host country: