Trial of SAVVY Vaginal Gel and HIV in Nigeria

Phase 3

• Conditions: HIV Infections

• Registration Number: NCT00130078
• Lead Sponsor: Biosyn

Brief Summary

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Detailed Description

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Study Timeline

• Study Start: 2004-09
• Status Verified: 2005-08
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-15
• Last Update Submitted: 2005-09-22
• Last Update Posted: 2005-09-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2142

Inclusion Criteria

• 18 to 35 year old women
• HIV negative
• More than one sexual partner in past 3 months
• Average 3 coital acts per week
• Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria

• HIV positive
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combined incidence of HIV-1 and HIV-2

Trial Locations

Locations (2)

Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan; 🇳🇬 Ibadan, Nigeria

Nigerian Institute of Medical Research; 🇳🇬 Lagos, Nigeria