AIDS/HIV Clinical Trials

• FDA issues a letter to all IND-holders of antiretrovirals in the development for HIV. The purpose is to encourage sponsors to study their drug in heavily treated patient populations with limited treatment options, and to collaborate with other drug sponsors to develop therapeutic options. The letter clarifies the agency's position on combining investigational drugs in clinical trials, and designing trials that include treatment experienced populations.  This letter was drafted in response to discussions held with representatives of several community groups, at the "Salvage Workshop" in Toronto, Canada, in May 1999.
• Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS (January 1996)
• Enrollment of Women in HIV Clinical Trials
  An evaluation abstract of the proportion of women enrolled in federally and privately sponsored clinical trials for HIV/AIDS therapies initiated between 1989-1994
• AIDSinfo
  The National Library of Medicine (part of NIH) maintains this interactive database that can help you locate trials studying HIV/AIDS.
• What Is an AIDS Clinical Trial?
  The National Library of Medicine (part of NIH) provides basic information about trials and questions to ask if you are considering participating in a clinical trial. (En Español: ¿Qué es un ensayo clínico sobre la infección por el VIH/SIDA?)