Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00458393 · ClinicalTrials.gov registry record · Phase 3
Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 2,499
- Enrollment target
NCT00458393: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00458393 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,499 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (224% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458393, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,499 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).
Primary Outcome
Confirmed HIV infection
Interventions
- DRUG Placebo
- DRUG daily TDF/FTC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,499 participants |
| Start Date | 2007-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00458393 record still lists
NCT00458393 is an interventional study that assigns participants to a tested intervention. Its 2,499 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (224% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00458393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458393 about?
NCT00458393 is a clinical study titled "Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men". The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).
What is the current status of trial NCT00458393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,499 participants. The study started on 2007-06. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00458393?
The interventions under investigation include: Placebo (DRUG), daily TDF/FTC (DRUG).
Who is sponsoring clinical trial NCT00458393?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458393's enrollment target sits among peer trials
2,499 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001160 · 2,500 participants
Studies on Tumors of the Thyroid
- NCT01904188 · 2,500 participants
Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
- NCT02257229 · 2,500 participants
Prospective Evaluation of Treatment for Clubfoot
- NCT02530658 · 2,500 participants
Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia