At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Maraviroc, Emtricitabine, and 4 other interventions for HIV Infection. Completed, enrolled 594 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
300-mg tablet, once daily, from Week 0 through Week 48
200-mg capsule, once daily, from Week 0 through Week 48
300-mg tablet, once daily, from Week 0 through Week 48
Once daily from Week 0 through Week 48
Once daily from Week 0 through Week 48
Once daily from Week 0 through Week 48