Title: Phase II/IIb Safety And Effectiveness Study Of The Vaginal Microbicides Buffer Gel and PRO 2000/5 (P) For The Prevention Of HIV Infection In Women (HPTN 035)

Sponsor: Division of AIDS, US National Institute of Allergy and Infectious Diseases

Co-sponsors: ReProtect, Inc and Indevus Pharmaceuticals, Inc

Principal Investigator 

Prof Z Mike Chirenje 
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Study Summary

The aim of the study is to assess the safety and effectiveness of two candidate vaginal microbicides in preventing male to female HIV transmission in high-risk, sexually active women aged 18 to 35 years.

This is a multi-site study being carried out in Zimbabwe, Malawi (Blantyre and Lilongwe), South Africa (Durban and Hlabisa), Zambia (Lusaka), and The USA (Philadelphia). The total enrolment across all sites is 3100 participants.

The Zimbabwe site operates from 2 research clinics namely Seke South in Chitungwiza and Spilhaus in Harare. The first participant at this site was enrolled in January 2006 marking the beginning of phase II of the study which was conducted among 51 participants as an uninterrupted lead-in to phase IIb of the study. A total of 484 women were enrolled over a period of 18 months. The follow up of participants will continue till the end of July 2008.

Participants were randomized into 4 arms: 3 arms using gel and 1 arm using condoms only. The 3 study gel arms are double blind. Each participant is followed up monthly (with specific quarterly visits) for a minimum of 12 months to a maximum of 30 months. All participants receive on going HIV risk reduction counseling, condoms and diagnosis/treatment of sexually transmitted infections.

Study Contacts

1. Nyaradzo Mgodi (Medical Officer)
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2. Margaret Mlingo (Study Coordinator)
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