Film Antiretroviral Microbicide Evaluation (FAME-02)

The FAME-02 Phase I study, the first human study to evaluate a vaginal film containing an ARV drug, compared the safety, drug absorption and drug distribution of dapivirine film to dapivirine gel. 

PK/PD of Single Dose Dapivirine Vaginal Film (FAME-02B) 

*Results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2014: The levels of dapivirine in the blood were comparable across the film and gel arms, suggesting that both products can deliver drugs in a similar manner. While the levels of dapivirine in vaginal tissue were higher in gel users than film, both the film and gel protected against HIV in challenge models of biopsied cervical tissue.*

Last updated May 15, 2021