HPTN 069
Phase II Randomized, Double-Blind, Study of Safety and Tolerability of Maraviroc, Maraviroc + Emtricitabine, Maraviroc + Tenofovir or Tenofovir + Emtricitabine for PreExposure Prophylaxis to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men
NEXT-PREP: Novel Exploration of Therapeutics for PREP
Protocol Status: Pending
Study Purpose: To assess the safety and tolerability of four antiretroviral (ARV) drug regimens used as pre-exposure prophylaxis (PrEP) to prevent HIV transmission in a population of at-risk men who have sex with men (MSM).
Study Design: Phase II, four-arm, multisite, randomized, double-blinded trial.
Study Population: HIV-uninfected at-risk MSM recruited from sites in the United States (U.S.). Sites are strongly encouraged to enroll young adult (aged 18-25) MSM and/or MSM of color to maximize representation from these groups. Each site will be asked to work with their Community Advisory Boards (CABs) and outreach, education and recruitment teams to develop a recruitment plan that will focus on the engagement of MSM who are younger and/or of color.
Study Size: Four hundred (400) participants. Seventy-two (72) participants (18 per arm) will be asked to enroll in a Drug Interaction Subset. Sixty (60) participants (15 per arm at selected sites) will be asked to enroll in a Tissue Subset.
Study Duration: Approximately two years. Accrual will require approximately 9 months, and each participant will be followed for approximately 12 months (study drug will be stopped at Week 48, with a final post-study drug visit at Week 49).
Treatment Regimen: The antiretroviral drugs (ARVs) being used in this study are: maraviroc (MVC) 300 mg, emtricitabine (FTC) 200 mg, tenofovir disoproxil fumarate (TDF) 300 mg, and matching placebos. Participants will be randomized to one of four arms as follows:
Arm 1: MVC 300 mg + [FTC placebo] + [TDF placebo] orally once daily.
Arm 2: MVC 300 mg + FTC 200 mg + [TDF placebo] orally once daily.
Arm 3: MVC 300 mg + [FTC placebo] + TDF 300 mg orally once daily.
Arm 4: [MVC placebo] + FTC 200 mg + TDF 300 mg orally once daily.
Study Regimen = 3 pills daily. All arms receive at least one active drug.
Primary Objectives: To assess the safety and tolerability of MVC, MVC+FTC, MVC+TDF, and TDF+FTC over 48 weeks. This will be measured by the occurrence of Grade 3 and higher adverse events (safety) and time to permanent discontinuation (tolerability) in each of the four study arms.
Secondary Objectives: - Assess Grade 2 and higher adverse events. - Assess changes in lipids in each of the four study arms. - Assess changes in bone mineral density in each of the four study arms. - Evaluate interactions of MVC, FTC, and TDF in the four study arms in a subset of participants (Drug Interaction Subset). - Evaluate concentrations of MVC, FTC, tenofovir (TFV) and their phosphorylated derivatives (FTC-triphosphate (FTC-TP) and TFV-diphosphate (TFV-DP)) in plasma, peripheral blood mononuclear cells (PBMC), and rectal samples in a subset of participants (Tissue Subset). - Assess changes in peripheral blood (all participants) and gut-associated lymphoid tissue (GALT) T cell phenotype (Tissue Subset). - Assess adherence in each of the four study arms as measured by an electronic medical device (EMD) and self-report. - Assess and characterize changes in sexual behavior as measured by computer-assisted self-interview (CASI). - Assess the relationship between adherence and sexual risk-taking. - Evaluate the association of drug concentrations with other adherence measures. - Assess quality-of-life in each of the four study arms.
SDMC Project Manager: Leslie Cottle get info
Protocol Team Member: Adriana Andrade get info
Protocol Team Member: Alex Rinehart get info
Protocol Team Member: Bruce Schackman get info
Protocol Team Member: David Burns get info
Protocol Team Member: David Roy Bangsberg get info
Protocol Team Member: Fulvia Veronese get info
Protocol Team Member: James Rooney get info
Protocol Team Member: Jonathan Lucas get info
Protocol Team Member: Joseph Margolick get info
Protocol Team Member: Kate MacQueen get info
Protocol Team Member: Paul Richardson get info
Protocol Team Member: Raphael Landovitz get info
Protocol Team Member: Rivet Amico get info
Protocol Team Member: Susan Eshleman get info
Protocol Team Member: Todd Brown get info
Protocol Team Member: Wairimu Chege get info
Protocol Statistician: Ying Q. Chen get info
Protocol Co-Chair: Kenneth H. Mayer get info
Protocol Co-Chair: Tim Wilkin get info
Protocol Chair: Roy Gulick get info
CORE Protocol Specialist: Marybeth McCauley get info
CORE Protocol Specialist: Phaedrea Watkins get info
CORE Protocol Specialist: Philip Andrew get info
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201 Baltimore, United States |
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31602 Boston, United States |
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Registered |
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3201 Chapel Hill, United States |
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Registered |
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2501 Cleveland, United States |
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Registered |
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601 Los Angeles, United States |
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7804 New York, United States |
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Hospital of University of Pennsylvania CRS 6201 Philadelphia, United States |
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1001 Pittsburgh, United States |
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San Francisco Vaccine and Prevention CRS 30305 San Francisco, United States |
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5401 San Juan, United States |
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University of Washington AIDS CRS 1401 Seattle, United States |
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31608 Washington, United States |
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