Title: A Phase 2B Safety and Effectiveness study of Tenofovir 1% Gel,Tenofovir Disoproxil Fumarate (DF) Tablet and Emtricibate/Tenofovir Disoproxil Fumarate (DF) tablet for the prevention of HIV Infection in Women.

Sponsor: National Institutes of Health (NIH)

Principal Investigators

Zimbabwe :

Professor Z.M Chirenje
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Study Summary

The aim of the study is to estimate the effectiveness of daily Tenofovir 1% gel compared to a vaginal placebo gel and the effectiveness of oral TDF and Oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infection (STI). To evaluate the extended safety of daily Tenofovir 1% gel, oral TDF, and oral FTC/TDF in women at risk for sexually transmitted HIV infection.

This is a a Phase 2B, five-arm, double blinded, placebo-controlled, multi-site, randomised, controlled Trial being carried out in Zimbabwe, Uganda, South Africa, Zambia and Malawi.The study targets only sexually active HIV-Uninfected women between 18-40 years old. The total enrolment across all sites is set at 5000 participants who meet the above study criteria.

The Zimbabwe site operates from 3 research clinics, namely Spilhaus in Harare, Zengeza and Seke South both in Chitungwiza.

The Study duration is approximately 35 months total. Accrual will require approximately 21 months and follow up will continue until 217 incident HIV infections are observed in the study, which is expected to occur approximately 14 months after the end of the accrual period. Each participant is expected to have a minimum of 12 and a maximum of 33 months of study product use. Each participant will have an additional approximate 8 weeks of follow-up off study product to identify potential delayed seroconversion due to masked infections that are not detected during the product use period.

Latest on MTN 003

To date the MTN 003 Study has enrolled 220 participants and still enrolling.

Study Contacts

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