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NCT01505114 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 594
- Enrollment target
NCT01505114: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01505114 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 594 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (347% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01505114, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 594 participants
- Enrollment target
Study Summary
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in men who have sex with men who may be at risk of getting HIV infection through sex and women who may be at risk of getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC), MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. The MVC-containing arms will be compared to TDF/FTC alone and in combination.
Primary Outcome
participants had Occurrence of Grade 3 or higher adverse events (AEs)
Interventions
- DRUG Maraviroc
- DRUG Tenofovir disoproxil fumarate
- DRUG Emtricitabine
- OTHER Maraviroc placebo
- OTHER Emtricitabine placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 594 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT01505114 record still lists
NCT01505114 is an interventional study that assigns participants to a tested intervention. The registered 594 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 (347% higher).
The record links to 0 conditions, and to 5 interventions - of which Maraviroc is the first listed.
NCT01505114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01505114 about?
NCT01505114 is a clinical study titled "Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women". Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in men who have sex with men who may be at risk of...
What is the current status of trial NCT01505114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 594 participants. The study started on 2012-06. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01505114?
The interventions under investigation include: Maraviroc (DRUG), Tenofovir disoproxil fumarate (DRUG), Emtricitabine (DRUG), Maraviroc placebo (OTHER), Emtricitabine placebo (OTHER).
Who is sponsoring clinical trial NCT01505114?
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 NCT01505114's enrollment target sits among peer trials
594 57th of 2000 higher than 1,943 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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