Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment 1.0% c31g savvy vaginal gel
Phase phase 3
Sponsor Biosyn
Collaborator FHI 360
Start date January 2004
Trial size 2142 participants
Trial identifier NCT00129532, 9779

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
combined incidence of HIV-1 and HIV-2
time frame:

Eligibility Criteria

Female participants from 18 years up to 35 years old.

Inclusion Criteria: - 18 to 35 year old women - HIV negative - More than one sexual partner in past 3 months - Average of 3 coital acts per week - Willing to use vaginal gel and condoms for 12 months Exclusion Criteria: - HIV positive - Pregnant

Additional Information

Official title Randomized Controlled Trial of SAVVY and HIV in Ghana
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Biosyn.