Trials / Completed
CompletedNCT00304642
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (planned)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dapivirine (TMC120) vaginal gel |
Timeline
- Start date
- 2005-11-01
- First posted
- 2006-03-20
- Last updated
- 2006-06-02
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT00304642. Inclusion in this directory is not an endorsement.