FAME-02 (Film Antiretroviral Microbicide Evaluation) was a double-blinded, placebo-controlled, randomized Phase I study that evaluated the safety, drug absorption and drug distribution of a film releasing dapivirine for use around the time of sex, compared to dapivirine gel. Participants used their assigned product once daily for seven days.
The study was conducted by the FAME Consortium and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH. IPM provided dapivirine for the trial.
- ClinicalTrials ID: NCT01548560
Publications, presentations or other scientific data
- Bunge et al. A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of a novel dapivirine vaginal film. JAIDS 2017. See abstract.