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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01505114
The ClinicalTrials.gov registry entry for NCT01505114 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 594 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Maraviroc is the first listed.
NCT01505114 reports 0 study locations.
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.
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