HPTN 069/ACTG 5305 (NEXT-PrEP)

Status:Completed
Phase:II
Principal Investigator(s):Roy M. Gulick, MD, MPH
Objective:Designed to evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in a population of 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 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.
Prevention Option(s):PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionMVC 300 mg plus FTC placebo and TDF placebo orally once daily
Mode of DeliveryTablet
ARMsExperimental
DescriptionMVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Mode of DeliveryTablet
ARMsExperimental
DescriptionMVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Mode of DeliveryTablet
ARMsExperimental
DescriptionMVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Mode of DeliveryTablet
ARMsExperimental
Results: Maraviroc, an oral drug used to treat HIV infection, is safe and well-tolerated when taken daily as pre-exposure prophylaxis
Official Code: NCT01505114
Related Publications:
Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Tria
Trial Sponsors: ACTG, HPTN, NIAID
Start Date
End Date
June 30, 2012
November 2, 2015
Enrollment:600
Age range: 18 Years ↔ any
Population:Cisgender Women, Gay and Bisexual Men Who Have Sex with Men