A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) Vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.|