HPTN HIV Prevention Preparedness Study Protocol Pune, India

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As described most recently by the researchers, health care providers, and community representatives who attended the International AIDS Conference this year, HIV/AIDS continues to exact a devastating toll on the health, economic and political infrastructure, and social fabric of communities worldwide. The Joint United Nations Programme on HIV/AIDS estimates that 34.3 million adults and children were living with HIV/AIDS at the end of 1999, and that more than 15,000 new infections are occurring each day.  Over 95 percent of new infections are occurring in developing countries where there is little access to the treatments that have prolonged life in industrialized countries.

It has been stated that a safe and effective vaccine remains the best hope for ending the HIV/AIDS pandemic, however the timeline for developing and making available a safe and effective HIV/AIDS vaccine to communities affected by the pandemic remains unclear.  While the search for an HIV/AIDS vaccine continues, additional research must be conducted to develop and test non-vaccine strategies to prevent the spread of HIV.

Earlier this year, the United States (US) National Institutes of Health (NIH) established the HIV Prevention Trial Network for this purpose.  This global network is the NIH’s largest multicenter research network and is comprised of a core operations center, a statistical and data management center, a central laboratory, and 25 research sites and sub-sites located in Africa, Asia, Europe, South America, and the US, including Pune, India. The HPTN will focus on six areas of HIV prevention research, as follows:

         Interventions to prevent mother-to infant HIV transmission.
         Interventions — termed microbicides — designed for vaginal and/or rectal use to prevent sexual transmission of HIV.
         Interventions to reduce behaviors that expose people to HIV.
         Interventions to prevent HIV infection through the reduction of injection drug use.
         Interventions to control other sexually transmitted diseases and thereby reduce the risk of HIV infection.
         Interventions based on antiretroviral therapy designed to prevent infection among persons exposed to HIV.

The HPTN will conduct research in all of the above areas at all phases of development, ranging from pilot/feasibility studies to Phase I and II safety studies to Phase III efficacy or effectiveness studies.  While early phase studies of a particular intervention are underway, work will proceed in parallel to ensure network-wide planning and preparedness to conduct Phase III studies of interventions shown to be safe and acceptable in earlier phase studies.