IPM 004

Details

Protocol Title:  A Study to Assess the Pharmacokinetics of TMC120 Vaginal Microbicide Gel (TMC120 GEL-002) in Healthy HIV-Negative Women

Status:  Completed

Description

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.

Participating Research Centers

  • FARMOVS-PAREXEL (University of Free State) – Bloemfontein, South Africa

Publications, presentations or other scientific data