Email Updates

You are here

Home

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
Randomized
Double-blind
Arms and Assigned Interventions
Description
Active immediate: Daily dosing immediately upon enrollment.
Mode of Delivery
Tablet
Products
TDF
ARMs
Experimental
Description
Placebo immediate: Daily dosing immediately upon enrollment.
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Description
Active delayed: Daily dosing nine months after enrollment.
Mode of Delivery
Tablet
Products
TDF
ARMs
Experimental
Description
Placebo delayed: Daily dosing nine months after enrollment.
Mode of Delivery
Tablet
ARMs
Placebo Comparator
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
Product Developers
Gilead Sciences, Inc.
February 2005
August 2009
Enrollment
400
18
Years
60
Years
Population
MSM
Sites

AIDS Research Consortium of Atlanta

Atlanta, Georgia
United States of America

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts
United States of America

San Francisco Department of Public Health

San Francisco, California
United States of America