A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase
I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of
dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy
HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive
2.5mL dapivirine vaginal microbicide gel at one of three concentrations.