Moving Toward Assured Access to Treatment in Microbicide Trials

P ublic concern about ethics in HIV-prevention trials intensifi ed in the last 18 months, reaching a fl ashpoint that resulted in the halting of two clinical trials to test the effi cacy 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 combination-therapy 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 high-risk populations have been planned to date. Two of these were halted by government order of the host country: one in Cambodia in August 2004 and one in Cameroon in February 2005. In March 2005, the PREP Nigerian trial was also stopped; but this occurred because, according to the trial sponsor, the local clinical trial site was unable to achieve " the necessary scientifi c standards. " Intense controversy among trial sponsors, HIV/AIDS activists, and some trial participants gave rise to these politicized, trial-halting decisions. Voices on all sides have expressed strong opinions – with some charging that the rights and interests of the highly vulnerable populations enrolling in the trials were not adequately protected and that the trials were, therefore, unethical. One key issue in this debate has been the provision of antiretroviral treatment (ART) to those who seroconvert during the trial—generally referred to as " access to care. " Public perception of researchers' responsibility in this area is rooted in the physician's traditional obligation to provide research participants with the best possible care. What this tradition does not address, however, is the challenge of meeting such an obligation in an environment of massive inequalities. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has held several regional and international deliberations in the last seven years that addressed (among other issues) the question of access to care. In July 2003, they convened " HIV Treatment for Intercurrent Infections, " a consultation in which vaccine and microbicide researchers came together with social scientists, ethicists, community representatives, and donors. Together they affi rmed that providing ART conforms to several fundamental ethical principles: benefi cence , by which researchers are obliged to maximize benefi ts to participants; reciprocity , which suggests that those who contribute important data to the study by …