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| Sponsor: | Centers for Disease Control and Prevention |
|---|---|
| Collaborators: |
San Francisco Department of Public Health AIDS Research Consortium of Atlanta |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00131677 |
Purpose
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 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 |
More Information
| Study ID Numbers: | CDC-NCHSTP-4323 |
| Study First Received: | August 17, 2005 |
| Last Updated: | September 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00131677 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |