NCT00441298

Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV

Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 889 (actual)
• Sponsor: Centre for the AIDS Programme of Research in South Africa · Network
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.

Detailed description

Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa. Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel. Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa Study Size: 900 women Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period. Study Duration: Approximately 30 months in total. Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study, which is expected to occur approximately 16 months after the end of the accrual period. Primary Objective: To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel, when applied intravaginally by women, in preventing sexually transmitted HIV infection. Secondary Objectives: * To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption * To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial. * To assess tenofovir resistance in HIV seroconvertors in the trial * To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes * To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance Ancillary Objective •To assess the impact, if any, of tenofovir gel in preventing sexually transmitted infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) infections. Study sites: * CAPRISA Vulindlela Clinical Research Site, KwaZulu-Natal, South Africa * CAPRISA eThekwini Clinical Research Site, Durban, South Africa

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Tenofovir gel	Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
DRUG	Placebo (Universal HEC placebo)	Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2007-02-28
• Last updated: 2016-02-01

Locations

2 sites across 1 country: South Africa