An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of
acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all
participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be
assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized
Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered
at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir
(TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0,
4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the
study will be discontinued from the study agent and followed for an additional 24 weeks after
the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or
renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed
for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of
potential concerns.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) University of North Carolina, Chapel Hill
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir