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Sponsors and Collaborators: |
Centers for Disease Control and Prevention San Francisco Department of Public Health AIDS Research Consortium of Atlanta |
Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00131677 |
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
Condition | Intervention | Phase |
HIV Infection |
Drug: Daily oral tenofovir |
Phase II |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men |
Estimated Enrollment: | 400 |
Study Start Date: | February 2005 |
This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
San Francisco Department of Public Health | |||||
San Francisco, California, United States, 94102 | |||||
United States, Georgia | |||||
AIDS Research Consortium of Atlanta | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Massachusetts | |||||
Fenway Community Health | |||||
Boston,, Massachusetts, United States, 02115 |
Centers for Disease Control and Prevention |
San Francisco Department of Public Health |
AIDS Research Consortium of Atlanta |
Principal Investigator: | Kata L Chillag, PhD | Centers for Disease Control and Prevention |
Principal Investigator: | Lisa A Grohskopf, MD, MPH | Centers for Disease Control and Prevention |
Principal Investigator: | Susan Buchbinder, MD | San Francisco Dept. of Public Health |
Principal Investigator: | Melanie Thompson, MD | AIDS Research Consortium of Atlanta |
Principal Investigator: | Kenneth H. Mayer, MD | Fenway Community Health |
Study ID Numbers: | CDC-NCHSTP-4323 |
First Received: | August 17, 2005 |
Last Updated: | September 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00131677 |
Health Authority: | United States: Federal Government |
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