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

NCT01505114 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	594
Start date	2012-06
Completion	2015-11

Conditions

• HIV Infection

Interventions

• Maraviroc
• Emtricitabine
• Tenofovir disoproxil fumarate
• Maraviroc placebo
• Emtricitabine placebo
• Tenofovir disoproxil fumarate placebo

Primary outcomes

• Occurrence of Grade 3 or Higher Adverse Events (AEs) — Through Week 48
  participants had Occurrence of Grade 3 or higher adverse events (AEs)

Countries

United States, Puerto Rico