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.
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
Prevention Option(s):Microbicides
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
Descriptiondapivirine gel
Mode of DeliveryGel
ARMsExperimental
Official Code:
NCT01548560
Trial Sponsors:
IPM
Start Date
End Date
August 1, 2012
February 1, 2014
Enrollment:60
Age range:
18 Years ↔
45 Years
Population:Cisgender Women