CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3,101 enrolled
Drug / intervention
BufferGel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00074425
NCT00074425Phase 2Completed
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Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 15, 2003·Updated Nov 8, 2021

In Brief

A Phase 2 clinical trial evaluating BufferGel, PRO 2000/5 Gel, and 1 other intervention for HIV Infections. Completed, enrolled 3,101 participants across 8 sites in 5 countries.

Detailed Summary

The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesMalawi, South Africa, United States, Zambia, Zimbabwe
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), HIV Prevention Trials Network

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2003
Enrollment StartJan 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 22.5 years ago

Interventions

BufferGeldrug

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.

PRO 2000/5 Geldrug

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.

Placebo geldrug

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.