IOM Releases Report on Best Practices for HIV Prevention Trials

"Methodological Challenges in Biomedical HIV Prevention Trials," Institute of Medicine: The report, sponsored by the Bill & Melinda Gates Foundation, examined methodological challenges and best practices in HIV prevention trials in an effort to increase trial efficacy and enable donors to invest resources efficiently. The report reviewed Phase II and Phase III HIV prevention trials and focused on microbicides and pre-exposure prophylaxis -- the practice of HIV-negative people taking antiretroviral drugs before potential exposure to the virus. The report says that because a "near-perfect biomedical intervention for preventing HIV infection is unlikely to be available in the near future," there is a "need for late-stage clinical trials of biomedical interventions that can detect and quantify modest intervention effects on HIV infection and adequately evaluate product safety." Specific recommendations from the report concerning pretrial research and planning, trial design, conducting late-stage trials and analyzing results are available online at the National Academies Press (Study abstract, 2/21).