National AIDS Research Institute (NARI), Pune, India, is a nodal HIV/AIDS research institute of the Indian Council of Medical Research (ICMR). The first international grant awarded to NARI in September 1992 was "Preparation for AIDS Vaccine Evaluation" (PAVE). This was followed by an NIH sponsored grant, viz., HIV Network for Prevention Trials (HIVNET) from November 1994. The HIVNET project was the largest, comprehensive epidemiological study of risk factors for HIV transmission in India and provided the first estimates of HIV incidence as well as the first documentation of clinical features of acute sero-conversion. The same site infrastructure was used for studies in acute sero-converters from 1997-1999 under a RO1 funded grant, which aimed at a more comprehensive follow-up of sero-converters and p24 antigenic individuals to study the immunopathogenesis of acute HIV infection. With initial focus on descriptive epidemiology and basic research, NARI is currently involved in clinical trials and applied research. The first clinical trial was carried out in 1998 and since then NARI has been participating in clinical trials funded by severa international and national organizations. NARI became a part of HPTN (034, 047, 052, 059 studies), ACTG (5175, 5185, 5190, 5199 studies) and vaccine trial networks (HVTN and IAVI). NARI CTU initiated the IAVI sponsored first phase I AIDS vaccine trial in India in January 2005. In response to NIH RFA (RFA-AI- 05-002) for Units for HIV/AIDS Clinical Trial Networks, NARI propose to apply to be identified as a 'Unit for HIV / AIDS Clinical Trials Network with participation in four networks, viz., Prevention of HIV infection [PTN];Optimization of clinical management including co-morbidities [ACTG];Microbicides [MTN] and Vaccine research and development [VTN]. NARI is proposing four Clinical Research Sites (CRS) at Pune city and one mere at the ICMR's National Institute for Research in Reproductive Health (NIRRH), Mumbai, a premier research organization working in basic clinical and operational research aspects of reproduction and sexual health. Both Pune and Murnbai are large industrial cities with populations of 3 million and 10 million respectively in the western high HIV prevalence state of Maharashtra in India. In view of the large susceptible and eligible populations available that would participate in clinical trials and infrastructure and expertise available at the two premier research institutes, namely, National AIDS Research Institute and Nations I Institute for Research in Reproductive Health of the ICMR in Pune and Mumbai, respectively and coupled with experience of actually conducting clinical trials, NARI is ideally placed to participate in the NIH sponsored global network of HIV/AIDS clinical trials. We feel confident that our participation in the NIH HIVAIDS clinical trial networks will compliment our national research priorities. ADMINISTRATIVE COMPONENT: