Treating people with intercurrent infection in HIV prevention trials. Report from a WHO/UNAIDS consultation, Geneva 17-18th July 2003.

While broad agreement now exists among sponsors of HIV prevention trials that antiretroviral therapy (ART) and a clinical care package should be provided to those who become infected during the conduct of a trial, certain practical issues remain unresolved, including Who should pay for ART? How long should ART be provided for? Does treatment extend outside of ART? What else should be included in the standard of care package and who should pay for it? Who should provide treatment and care? This report summarizes the discussions from a consultation held in Geneva (17-18 July 2003) organized by the World Health Organization (WHO) and the joint United Nations Programme on HIV/AIDS (UNAIDS). The group discussed issues related to the various types of HIV prevention trials covered - vaccines, microbicides, behavioural - the ethics and legal rational for providing treatment and care as well as relevant economic issues and developments around scale-up of treatment and care in middle- and lower-income countries. Also discussed were policies of certain research agencies, countries and international funding agencies. The implementation of the conclusions which came out of these discussions on the treatment and care for people who become infected during HIV prevention trials requires the active participation of members of the research community, funders of research, local and national governments and industry as well as the individuals or communities participating in the trials.