findmyKOL
Clinical trialNCT01505114CompletedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment594HIV Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • Puerto Rico Aids Clinical Trials Unit Crs

    San Juan, Puerto Rico

United States
  • Ucla Care Center Crs

    Los Angeles, California, United States

  • Bridge Hiv Crs

    San Francisco, California, United States

  • George Washington Univ. Crs

    Washington D.C., District of Columbia, United States

  • Johns Hopkins University Crs

    Baltimore, Maryland, United States

  • Fenway Health (fh) Crs

    Boston, Massachusetts, United States

  • New Jersey Medical School Clinical Research Center Crs

    Newark, New Jersey, United States

  • Weill Cornell Chelsea Crs

    New York, New York, United States

  • Chapel Hill Crs

    Chapel Hill, North Carolina, United States

  • Case Clinical Research Site

    Cleveland, Ohio, United States

  • Penn Therapeutics, Crs

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Crs

    Pittsburgh, Pennsylvania, United States

  • University of Washington Aids Crs

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2012
Primary completion
30 Nov 2015
Completion
30 Nov 2015
Last update posted
5 Nov 2021
Registered enrollment
594
Registry id
NCT01505114

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.