Protocol Title: A Phase I/II Single-Centre Double-Blind, Randomized Study of the Safety and Tolerability of Dapivirine Vaginal Microbicide Gel (TMC 120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women
IPM 005B is a Phase I/II trial that assessed the local safety of twice daily dapivirine gel on vaginal mucosa, systemic toxicity and tolerability in 36 healthy, HIV-negative women for 42 days. Product acceptability and adherence were also assessed.
The trial demonstrated that dapivirine gel administered twice daily for 42 consecutive days in healthy, HIV-negative women for 42 consecutive days was safe and well tolerated, suggesting that continued development is warranted.
Participating Research Centers
- SGS Life Sciences Services — Antwerp, Belgium
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.