FAME-02B (Film Antiretroviral Microbicide Evaluation) was a two-arm crossover, randomized Phase I study that assessed the safety, pharmacokinetics and pharmacodynamics of a film releasing dapivirine for use around the time of sex, compared to dapivirine gel. Participants were assigned to receive either a single dose of dapivirine gel followed by a single dose of dapivirine film, or dapivirine film followed by dapivirine gel. Participants received the second product only after a 14-day period and safety assessment.
The study was conducted by the FAME Consortium and sponsored by IPM.
- ClinicalTrials ID: NCT01924091
Publications, presentations or other scientific data
- Robinson et al. Comparison of Dapivirine Vaginal Gel and Film Formulation Pharmacokinetics and Pharmacodynamics (FAME 02B). AIDS Res Hum Retroviruses 2017. See abstract.