It can be predicted that once vaginal microbicide products such as tenofovir gel are approved for marketing, they would likely be used by females of all ages. Safety data for 1% tenofovir gel in adolescents has been requested by the FDA prior to product approval. MTN-021 is a Phase 1, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of repeated exposure (once daily for approximately 12 weeks) to 1% tenofovir gel applied vaginally in sexually experienced, HIV-uninfected adolescent females. This study is a collaborative effort between the MTN and the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) funded by NICHD. Approximately 90 adolescent females will be randomized in a 2:1 ratio to one of the following study groups: 1% tenofovir gel or placebo gel. A total of 20 evaluable participants will have blood drawn for this PK study and will be asked to insert a dose of gel at their 4-Week Study Visit followed by a single time-point PK measurement of tenofovir blood levels approximately 2 hours after gel insertion.
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institutes of Health
Phase 1, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial (2:1)