The National AIDS Research Institute (NARI), Pune, as a participant of a multi-site project called HIV Prevention Trial Network (HPTN) project, has set up an HIV prevention trial unit. The setting up of the unit was with the support from National Institute of Health, USA.

Elaborating on the project Dr.S Paranjape, officer in-charge, NARI, said, "HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV. NARI has HIV prevention trial unit under this HPTN project." He further stated that the overall goal is to make sure that the HIV prevention trials unit (HPTU) in Pune is at its best for the start, enrollment, and retention of participants for two upcoming HPTN clinical trials.

Dr. Paranjape informed that two trials are being planned under this HPTU. Under one trial, a Phase I trial of vaginal microbicide preparation PRO2000 is being carried out to estimate the effectiveness of PRO 2000 Gel in preventing HIV infection among at-risk women. This trial has just been initiated. Another trial is being planned in discordant couples to assess the efficacy of anti-retroviral therapy in reducing transmission of HIV from infected to uninfected partner. A preparatory phase of this trial has begun. The actual trial is expected to begin in six months time.

Though the trials are planned to be carried put in three phases, Dr. Paranjape clarified that, only if satisfactory results were obtained in Phase I, Phase II and III would be planned. "Unless results of the present trials are available, it is not possible to give time frame for phase II and III," he stated.

Dwelling on the number of participants for the trials, he said, in the preparatory phase, 400 HIV discordant couples are proposed to be enrolled. In actual trial, 250 discordant couples will be enrolled. While in Phase I trial of vaginal microbicide 60 women in the reproductive age group are proposed to be enrolled. Thirty of them will be from low/no risk for HIV infection and thirty will be from high-risk category.

In the trials involving HIV discordant couples, he said, this study wants to find out the rate of HIV infection and follow-up among a group of high-risk, HIV-negative non-sex worker women in Pune, as well as among HIV-discordant couples (couples where 1 partner is HIV-infected and the other is not). "Phase III studies of HIV prevention require the participation of a large number of people at high risk for HIV infection. It is also important that these participants continue and follow through with the study through the extended period of follow-up," noted Dr. Paranjape. He further pointed out that a measurement of HIV incidence and retention rate among high-risk women and HIV-discordant couples is necessary for upcoming HPTN trials.

According to Dr. Paranjape, with the need for estimates of HIV incidence and the need for data to ensure high retention rates, this protocol is important for the HPTN generally and for HPTU in Pune in particular.