This article is more than 5 years old. Information may no longer be current.
Early data for dapivirine microbicide gel show promise
Nel AM. JAIDS. 2010; 55:161-169
Click Here to Manage Email Alerts
Two dapivirine-based microbicide gels for the prevention of HIV were safe and well-tolerated in a cohort of women who did not have HIV, according to recent study results.
The randomized, double-blind, phase-1 trial involved 36 healthy women and compared pharmacokinetics and safety of two .05% dapivirine vaginal microbicide gel formulations with hydroxyethyl cellulose-based universal placebo gel.
Participants self-administered the gel for 11 days. The researchers collected blood and vaginal fluid samples over a 24-day period.
Results indicated similar adverse event profiles for all three gels. Though events were reported, they were mild, and none were attributed to the study gel. The most commonly reported adverse events included headache and vaginal hemorrhage, which was defined as any vaginal bleeding.
Plasma analysis results indicated that dapivirine concentrations did not exceed 1.1 ng/mL. The researchers reported that steady-state conditions were reached within approximately 10 days, according to the results.
One of the gels — known currently as gel 4789 — yielded higher dapivirine concentrations in vaginal fluids. However, data from days 1 and 14 indicated no significant differences in Cmax values at those time points.
A terminal half-life of 72 to 73 hours was observed in plasma and 15 to 17 hours in vaginal fluids.
“Dapivirine was delivered to the lower genital tract at concentrations at least 5 logs greater than in vitro inhibitory concentrations,” the researchers wrote.