Trials / Completed
CompletedNCT00131677
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Centers for Disease Control and Prevention · Federal
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tenofovir disoproxil fumarate | study product taken daily |
| DRUG | placebo | study product taken daily |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2005-08-19
- Last updated
- 2014-03-10
- Results posted
- 2014-03-10
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00131677. Inclusion in this directory is not an endorsement.