Protocol Title: A Study to Assess the Pharmacokinetics of TMC120 Vaginal Microbicide Gel (TMC120 GEL-002) in Healthy HIV-Negative Women
IPM 004 is a Phase I trial to assess the plasma levels and pharmakokinetics of dapivirine vaginal gel in concentrations of 0.001%, 0.005% and 0.02% for 10 consecutive days in healthy women.
A total of 18 HIV-negative women in South Africa completed the trial, with six each in the three concentration groups. IPM 004 concluded that dapivirine appeared safe and well-tolerated. Pharmacokinetic data supported future testing of dapivirine gel as a once-daily microbicide.
- ClinicalTrials ID: NCT00304642
Participating Research Centers
- FARMOVS-PAREXEL (University of Free State) – Bloemfontein, South Africa
Publications, presentations or other scientific data
- Nel et al. Pharmacokinetic assessment of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS Research and Human Retroviruses 2010. See abstract.