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

NCT00441298 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 889

Last updated 2016-02-01

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • FHI 360

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • CONRAD

    collaborator OTHER

  • Centre for the AIDS Programme of Research in South Africa

    lead NETWORK

Principal Investigators

  • Salim S Abdool karim, MBChB, PhD · CAPRISA, University of KwaZulu-Natal

  • Quarraisha Abdool Karim, PhD · CAPRISA, University of KwaZulu-Natal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441298 on ClinicalTrials.gov