Trial of SAVVY Vaginal Gel and HIV in Nigeria

Biosyn2,142 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,142

Conditions

HIV Infections

Interventions

1.0% C31G SAVVY vaginal gelDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan

Ibadan, Nigeria

RECRUITING

Nigerian Institute of Medical Research

Lagos, Nigeria

RECRUITING

Outcomes

Primary Outcomes

Combined incidence of HIV-1 and HIV-2

Central Contacts

Paul Feldblum

CONTACT

919 544-7040 pfeldblum@fhi.org

Data from ClinicalTrials.gov

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