Protocol Title: A Phase I/II Double-Blind, Randomized, Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel (TMC120 GEL-002) and Matching Placebo in Healthy HIV-Negative Women
IPM 003 is a Phase I/II trial that assessed the safety and tolerability of dapivirine (TMC120) Gel-002 used twice daily against a “universal” placebo gel. A total of 112 healthy HIV-negative women in Rwanda, South Africa and Tanzania were enrolled the study with 32 each in the 0.001% and 0.002% groups, 31 in the 0.005% group, and 16 in the placebo group. Women used the product for 42 consecutive days. The study concluded that dapivirine (TMC120) Gel-002 administered twice daily for 42 consecutive days in healthy HIV-negative women was safe and well tolerated, suggesting that continued development of dapivirine is warranted.
- ClinicalTrials ID: NCT00303576
Participating Research Centers
- Projet Ubuzima — Kigali, Rwanda
- FARMOVS-PAREXEL (University of Free State) — Bloemfontein, South Africa
- Reproductive Health & HIV Research Unit (RHRU) — Johannesburg, South Africa
- Kilimanjaro Christian Medical Centre (KCMC) — Moshi, Tanzania
Publications, presentations or other scientific data
- Nel et al. Safety, tolerability, and systemic absorption of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS 2009. See abstract.