Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
112
Projet Ubuzima
Kigali, Rwanda
Reproductive Health Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
Farmovs-Parexel
Bloemfontein, South Africa
Kilimanjaro Reproductive Health Program
Moshi, Tanzania
Local and systemic safety and tolerability.
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