A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
Public ClinicalTrials.gov record NCT00799058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
Study identification
- NCT ID
- NCT00799058
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Industry
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- Drug placebo Drug
- dapivirine 4789 Drug
- dapivirine gel 4759 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 5, 2009
- Primary completion
- Jan 7, 2011
- Completion
- Jan 7, 2011
- Last update posted
- Oct 24, 2022
2009 – 2011
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS) | Birmingham | Alabama | 35294 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | — |
| Albert Einstein College of Medicine | New York | New York | 10461 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00799058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 24, 2022 · Synced May 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00799058 live on ClinicalTrials.gov.