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NCT00131677 · ClinicalTrials.gov registry record · Phase 2
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
A Phase 2 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
NCT00131677: Completed Phase 2 study, sponsored by Centers for Disease Control and Prevention.
NCT00131677 is a Phase 2 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 400 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (201% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00131677, a Phase 2 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
Study Summary
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
Primary Outcome
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
Interventions
- DRUG placebo
- DRUG tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00131677 record still lists
NCT00131677 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (201% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00131677 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00131677 about?
NCT00131677 is a clinical study titled "Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men". The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
What is the current status of trial NCT00131677?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2005-02. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00131677?
The interventions under investigation include: placebo (DRUG), tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT00131677?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00131677's enrollment target sits among peer trials
400 96th of 2000 higher than 1,898 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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