A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one
research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age,
randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the
pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or
Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day
washout period and then 10 consecutive days); and to assess the safety of these gels as
compared to the intravaginal HEC-based universal placebo gel.