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 and in At-Risk Women


What is NEXT-PREP: Novel Exploration of Therapeutics for PREP

HPTN 069/ACTG 5305, also known as NEXT-PrEP, is an HIV prevention study that is being done to learn more about the safety and acceptability of four different drug combinations when used as PrEP by men who have sex with men and women. PrEP is a new HIV prevention method in which people who are HIV-negative take HIV treatment drugs (antiretrovirals – ARVs) daily to reduce their risk of becoming HIV-infected. All of the drugs used in the study are approved by the Food and Drug Administration (FDA) to treat people with HIV infection. The drugs in this study are called maraviroc (also called Selzentry or MVC), emtricitabine (also called Emtriva or FTC), and tenofovir (also called Viread or TDF).

 

 


Protocol Status: Enrolling

Study Summary

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) and in at-risk women.

Study Design: Phase II, four-arm, multisite, randomized, double-blinded trial.

Study Population: HIV-uninfected at-risk MSM and at-risk women recruited from sites in the United States (U.S.). Sites are strongly encouraged to enroll young adult (aged 18-25) MSM and/or MSM or women 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 MSM and women of color.

Study Size: Four hundred (400) MSM and 200 women. Seventy-two (72) participants (18 per arm) will be asked to enroll in a Drug Interaction Subset. Sixty (60) men and 60 women (15 male/15 female per arm) at selected sites will be asked to enroll in a Tissue Subset.

Study Duration: Approximately 30 months. Accrual will occur in a staggered fashion, with men beginning first, and women beginning several months later. Accrual for the men will require approximately 9 months, and accrual for the women will require approximately 9 months. 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: 1) Assess Grade 2 and higher adverse events, and Grade 1 clinical (non-laboratory) adverse events that lead to a temporary or permanent hold in study drug. 2) Assess changes in lipids in each of the four study arms. 3) Assess changes in bone mineral density in each of the four study arms. 4) Evaluate interactions of MVC, FTC, and TDF in the four study arms in a subset of participants (Drug Interaction Subset). 5) 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), rectal tissue and fluid, and cervical tissue and cervicovaginal fluid, in a subset of participants (Tissue Subset).. 6) Assess changes in peripheral blood (all participants) and gut-associated lymphoid tissue (GALT) T cell phenotype (Tissue Subset). 7) Assess adherence in each of the four study arms as measured by an electronic medical device (EMD) and self-report. 8) Assess and characterize sexual behavior over time as measured by computer-assisted self-interview (CASI). 9) Assess the relationship between adherence and sexual risk-taking. 10) Evaluate the association of drug concentrations with other adherence measures. 11) 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: Ana Martinez get info

Protocol Team Member: Bruce Schackman get info

Protocol Team Member: Cheryl J. Marcus get info

Protocol Team Member: Craig Hendrix get info

Protocol Team Member: Fulvia Veronese get info

Protocol Team Member: Ian M. McGowan 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: Karin Klingman 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: Rebecca Guzman get info

Protocol Team Member: Rivet Amico get info

Protocol Team Member: Sally Hodder 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: Alicia Young 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: Andrea Jennings get info

CORE Protocol Specialist: Marybeth McCauley get info

CORE Protocol Specialist: Phaedrea Watkins get info

CORE Protocol Specialist: Philip Andrew get info

Site Target
Enrollment
Cumulative
Enrollment
Implementation
Status
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Info

Johns Hopkins Adult AIDS CRS

201

Baltimore, United States

24 men, 15 women

23 men, 1 women

Enrolling

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Fenway Health CRS

31785

Boston, United States

50 men, 20 women

50 men, 15 women

Enrollment Closed

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UNC AIDS CRS

3201

Chapel Hill, United States

35 men, 15 women (across the UNC and Wake County sites)

35 men, 15 women (across the UNC and Wake County Sites)

Enrolling

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Case CRS

2501

Cleveland, United States

25 men, 12 women

33 men, 16 women

Enrolling

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UCLA CARE Center CRS

601

Los Angeles, United States

30 men, 15 women

30 men, 2 women

Enrolling

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Cornell CRS

7804

New York, United States

25 men, 12 women

29 men, 11 women

Enrolling

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New Jersey Medical School Clinical Research Center CRS

31786

Newark, United States

20 women

25 women

Enrolling

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Hospital of University of Pennsylvania CRS

6201

Philadelphia, United States

25 men, 12 women

32 men, 13 women

Enrolling

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Pitt CRS

1001

Pittsburgh, United States

25 men, 15 women

25 men, 6 women

Enrolling

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Wake County Health and Human Services CRS

30076

Raleigh, United States

35 men and 15 women (across the UNC and Wake County sites)

35 men and 15 women (across the UNC and Wake County sites)

Site Activated

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Bridge HIV CRS

30305

San Francisco, United States

50 men

50 men

Enrollment Closed

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Puerto Rico AIDS CRS

5401

San Juan, United States

25 men, 12 women

22 men, 14 women

Enrolling

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University of Washington AIDS CRS

1401

Seattle, United States

25 men, 12 women

27 men, 7 women

Enrolling

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George Washington Univ. CRS

31608

Washington, United States

50 men, 20 women

50 men, 20 women

Enrollment Closed

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