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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: tenofovir disoproxil fumarate Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: active immediate
participants in this arm start study product immediately upon enrollment
|
Drug: tenofovir disoproxil fumarate
study product taken daily
Other Name: Viread
|
|
Placebo Comparator: placebo immediate
participants in this arm start study product immediately upon enrollment
|
Drug: placebo
study product taken daily
|
|
Active Comparator: active delayed
persons in this arm start study product 9 months after enrollment
|
Drug: tenofovir disoproxil fumarate
study product taken daily
Other Name: Viread
|
|
Placebo Comparator: placebo delayed
participants in this arm start study product nine months after enrollment
|
Drug: placebo
study product taken daily
|
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
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00131677 History of Changes |
| Other Study ID Numbers: | CDC-NCHSTP-4323 |
| Study First Received: | August 17, 2005 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Federal Government |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Tenofovir disoproxil |
Tenofovir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |