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A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

NCT00799058 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-10-25

Study results available
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Summary

A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Conditions

  • HIV-1 Infections

Interventions

DRUG

dapivirine 4789

dapivirine gel 4789, 0.05%, 2.5g applied once daily

DRUG

dapivirine gel 4759

dapivirine gel 4759, 0.05%, 2.5g applied once daily

DRUG

Drug placebo

HEC-based universal placebo gel, 2.5g applied once daily

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr Annalene Nel · International Partnership for Microbicides

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-06
Primary Completion
2011-01-08
Completion
2011-01-08

Countries

  • United States

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 NCT00799058 on ClinicalTrials.gov