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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 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 128 participants.

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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

Interventions

  • DRUG dapivirine 4789
  • DRUG dapivirine gel 4759
  • DRUG Drug placebo

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2009-07-06
Est. Completion 2011-01-08
Phase Phase 1

What the Registry Record Tells You About NCT00799058

The ClinicalTrials.gov registry entry for NCT00799058 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International Partnership for Microbicides, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which dapivirine 4789 is the first listed.

NCT00799058 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.