CDC 4323

Status:Completed
Phase:II
Principal Investigator(s):Kata Chillag, PhD; Lisa Grohskopf, MD, MPH; Susan Buchbinder, MD; Melanie Thompson, MD; Kenneth Mayer, MD
Objective:To examine the safety and tolerability of daily oral TDF as PrEP for HIV-negative men who have sex with men (MSM).
Prevention Option(s):PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionActive immediate: Daily dosing immediately upon enrollment.
Mode of DeliveryTablet
ARMsExperimental
DescriptionActive delayed: Daily dosing nine months after enrollment.
Mode of DeliveryTablet
ARMsExperimental
Results: Randomized trial of clinical safety of daily oral tenofovir disoproxil fumarate among HIV-uninfected men who have sex with men in the United States.
Official Code: NCT00131677
Related Publications:
Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco.
Trial Sponsors: AIDS Research Consortium of Atlanta, Fenway Health, San Francisco Department of Public Health, US CDC
Start Date
End Date
February 28, 2005
August 31, 2009
Enrollment:400
Age range: 18 Years ↔ 60 Years
Population:Gay and Bisexual Men Who Have Sex with Men