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
Public ClinicalTrials.gov record NCT01505114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex With Men and in At-Risk Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01505114
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 594 participants
Conditions and interventions
Conditions
Interventions
- Maraviroc Drug
- Emtricitabine Drug
- Tenofovir disoproxil fumarate Drug
- Maraviroc placebo Other
- Emtricitabine placebo Other
- Tenofovir disoproxil fumarate placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2012 (Actual)
- Primary completion
- Nov 2015 (Actual)
- Completion
- Nov 2015 (Actual)
- Last update posted
- Nov 5, 2021
2012 – 2015
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA CARE Center CRS | Los Angeles | California | 90035 | — |
| Bridge HIV CRS | San Francisco | California | 94143 | — |
| George Washington Univ. CRS | Washington D.C. | District of Columbia | 20006 | — |
| Johns Hopkins University CRS | Baltimore | Maryland | 21205 | — |
| Fenway Health (FH) CRS | Boston | Massachusetts | 02215-4302 | — |
| New Jersey Medical School Clinical Research Center CRS | Newark | New Jersey | 07103 | — |
| Weill Cornell Chelsea CRS | New York | New York | 10010 | — |
| Chapel Hill CRS | Chapel Hill | North Carolina | 27599 | — |
| Case Clinical Research Site | Cleveland | Ohio | 44106 | — |
| Penn Therapeutics, CRS | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh CRS | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104-9929 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01505114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2021 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01505114 live on ClinicalTrials.gov.