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Film Antiretroviral Microbicide Evaluation (FAME-02)

Status
Completed
Phase
I
Principal Investigator(s)
Katherine Bunge
Objective

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. 

*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.*

Prevention Option(s)
Microbicides
Arms and Assigned Interventions
Description
dapivirine gel
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
placebo gel
Mode of Delivery
Gel
ARMs
Placebo Comparator
Description
dapivirine film
ARMs
Experimental
Description
placebo film
Mode of Delivery
Film
ARMs
Placebo Comparator
Population
Women
Sites

Magee Women's Hospital of UPMC

Pittsburgh
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America