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A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

NCT00304642 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2006-06-02

No results posted yet for this study

Summary

Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.

Conditions

  • HIV Infections

Interventions

DRUG

dapivirine (TMC120) vaginal gel

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Zeda Rosenberg, ScD · Beijing Immupeutics Medicine Technology Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-30

Countries

  • South Africa

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 NCT00304642 on ClinicalTrials.gov