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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

NCT01505114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2021-11-05

Study results available
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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.

Conditions

  • HIV Infection

Interventions

DRUG

Maraviroc

300-mg tablet, once daily, from Week 0 through Week 48

DRUG

Emtricitabine

200-mg capsule, once daily, from Week 0 through Week 48

DRUG

Tenofovir disoproxil fumarate

300-mg tablet, once daily, from Week 0 through Week 48

OTHER

Maraviroc placebo

Once daily from Week 0 through Week 48

OTHER

Emtricitabine placebo

Once daily from Week 0 through Week 48

OTHER

Tenofovir disoproxil fumarate placebo

Once daily from Week 0 through Week 48

Sponsors & Collaborators

  • HIV Prevention Trials Network

    collaborator NETWORK

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Roy M. Gulick, MD, MPH · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505114 on ClinicalTrials.gov