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NCT00799058 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A Phase 1 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
NCT00799058: Completed Phase 1 study, sponsored by International Partnership for Microbicides.
NCT00799058 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00799058, a Phase 1 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
Study 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
Primary Outcome
A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
Interventions
- DRUG dapivirine 4789
- DRUG dapivirine gel 4759
- DRUG Drug placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2009-07-06 |
| Est. Completion | 2011-01-08 |
| Phase | Phase 1 |
What the finished NCT00799058 record still lists
NCT00799058 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 3 interventions - of which dapivirine 4789 is the first listed.
NCT00799058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00799058 about?
NCT00799058 is a clinical study titled "A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States". 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
What is the current status of trial NCT00799058?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2009-07-06. Estimated completion is 2011-01-08.
What interventions are being tested in trial NCT00799058?
The interventions under investigation include: dapivirine 4789 (DRUG), dapivirine gel 4759 (DRUG), Drug placebo (DRUG).
Who is sponsoring clinical trial NCT00799058?
This trial is sponsored by International Partnership for Microbicides, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799058's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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