Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00131677 |
Recruitment Status :
Completed
First Posted : August 19, 2005
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
|
Sponsor:
Centers for Disease Control and Prevention
Collaborators:
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | August 17, 2005 | |||||||||||||||
First Posted Date ICMJE | August 19, 2005 | |||||||||||||||
Results First Submitted Date ICMJE | August 8, 2013 | |||||||||||||||
Results First Posted Date ICMJE | March 10, 2014 | |||||||||||||||
Last Update Posted Date | March 10, 2014 | |||||||||||||||
Study Start Date ICMJE | February 2005 | |||||||||||||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
|
|||||||||||||||
Original Primary Outcome Measures ICMJE |
Clinical and behavioral safety | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||||||||
Original Secondary Outcome Measures ICMJE |
|
|||||||||||||||
Current Other Pre-specified Outcome Measures |
>5% Bone Mineral Density Decline at Femoral Neck [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ] Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.
|
|||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men | |||||||||||||||
Official Title ICMJE | Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men | |||||||||||||||
Brief Summary | The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men. | |||||||||||||||
Detailed Description | 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. | |||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 2 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
|||||||||||||||
Condition ICMJE | HIV Infection | |||||||||||||||
Intervention ICMJE |
|
|||||||||||||||
Study Arms ICMJE |
|
|||||||||||||||
Publications * |
|
|||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||||||||
Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
400 | |||||||||||||||
Original Enrollment ICMJE | Same as current | |||||||||||||||
Actual Study Completion Date ICMJE | August 2009 | |||||||||||||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||
Ages ICMJE | 18 Years to 60 Years (Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | United States | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00131677 | |||||||||||||||
Other Study ID Numbers ICMJE | CDC-NCHHSTP-4323 | |||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | Centers for Disease Control and Prevention | |||||||||||||||
Study Sponsor ICMJE | Centers for Disease Control and Prevention | |||||||||||||||
Collaborators ICMJE |
|
|||||||||||||||
Investigators ICMJE |
|
|||||||||||||||
PRS Account | Centers for Disease Control and Prevention | |||||||||||||||
Verification Date | August 2013 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |