Conditions: HIV-1 Infections
Keywords: HIV-1 infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: yes

Brief summary:
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Detailed description:
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

Arms:
arm 1: will be applied by participants once daily for 12-weeks treatment period arm 2: Will be applied by participants once daily for12-weeks treatment period arm 3: Will be applied once daily for 12-weeks treatment period

Interventions: intervention 1: dapivirine 4789 intervention 2: dapivirine gel 4759 intervention 3: Drug placebo
Intervention descriptions: intervention 1: dapivirine gel 4789, 0.05%, 2.5g applied once daily intervention 2: dapivirine gel 4759, 0.05%, 2.5g applied once daily intervention 3: HEC-based universal placebo gel, 2.5g applied once daily

Protocol document: