Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1



Status:Terminated
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:January 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double‑Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral‑Naive Hiv‑Infected Patients With Ccr5‑Tropic Hiv‑1

The purpose of this study is to assess whether maraviroc administered once daily is
non-inferior to emtricitabine/tenofovir also administered once daily each in combination
with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at
Week 48 of treatment.

The study was terminated on October 8, 2013 following a preliminary review of the Week 48
primary efficacy data by the study's external independent Data Monitoring Committee (DMC).
The DMC assessed the data as demonstrating significant differences between the treatment
arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that
the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to
the comparator arm (Emtricitabine/Tenofovir).

Inclusion Criteria:

- Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening
Visit.

- CD4 count equal to or greater than 100 cells/mm3 at Screening.

- Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at
any time.

- Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and
emtricitabine.

- CXCR4 using virus detected using randomized tropism determination or repeated failure
to obtain an interpretable tropism result.
We found this trial at
83
sites
Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Central Texas Clinical Research
900 East 30th Street
Austin, Texas 78705
512-480-9660
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Howard Brown Health Center
4025 North Sheridan Road
Chicago, Illinois 60613
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Chicago, IL
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UT Southwestern Medical Center
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Wayne State University
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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University of Miami
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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New York Medical College
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Valhalla, NY
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AIDS Research Consortium of Atlanta
Atlanta, Georgia 30308
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Atlanta, GA
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University of Colorado Denver - University of Colorado Hospital
Aurora, Colorado 80045
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Be Well Medical Center
Berkley, Michigan 48072
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University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama 35294
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Erie County Medical Center
Buffalo, New York 14215
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I.D. Consultants, P.A.
Charlotte, North Carolina 28209
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Northwestern University/NMH
Chicago, Illinois 60611
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Northwestern University
303 East Superior Street
Chicago, Illinois 60611
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University of Cincinnati - Department of Internal Medicine
Cincinnati, Ohio 45267
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Dallas Diabetes and Endocrine Center
Dallas, Texas 75230
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Parkland Memorial Hospital
5201 Harry Hines Blvd
Dallas, Texas 75235
(214) 590-8000
Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246
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East Sydney Doctors
Darlinghurst, New South Wales 2007
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Infectious Disease Specialists of Atlanta
Decatur, Georgia 30033
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DeKalb Medical Diagnostic Breast Center
Decatur, Georgia 30033
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Kaiser Permanente of Colorado
Denver, Colorado 80205
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University Physicians Group
Detroit, Michigan 48201
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Henry Ford Health System
Detroit, Michigan 48202
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Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
East Lansing, Michigan 48824
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Biomedical and Health Institutional Review Board
East Lansing, Michigan 48825
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Broward Health - Comprehensive Care Center
Fort Lauderdale, Florida 33311
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Broward General Medical Center
Fort Lauderdale, Florida 33316
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East Carolina University Division of Infectious Diseases
Greenville, North Carolina 27834
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(DEXA Scan Facility) East Carolina University Brody Outpatient Center
Greenville, North Carolina 27834
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Kaiser Permanente
Hayward, California 94545
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Health Services Center
Hobson City, Alabama 36201
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Therapeutic Concepts, P.A.
Houston, Texas 77004
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Research Access Network
Houston, Texas 77098
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The Office of Dr. Gordon E. Crofoot, M.D., PA
Houston, Texas 77098
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University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
Iowa City, Iowa 52242
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Kansas City Free Health Clinic
Kansas City, Missouri 64111
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Ingham County Health Department
Lansing, Michigan 48911
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Anthony Mills MD Inc
Los Angeles, California 90069
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University of Miami AIDS Clinical Research Unit
Miami, Florida 33136
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The Kinder Medical Group
Miami, Florida 33133
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Community AIDS Resource Inc dba Care Resource
Miami, Florida 33137
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UMHC/Sylvester Comprehensive Cancer Center
Miami, Florida 33136
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Miami Research Associates
Miami, Florida
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Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida 33139
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Hennepin County Medical Center
Minneapolis, Minnesota 55414
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Jersey Shore University Medical Center
Neptune, New Jersey 07754
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Brandywine Common
Neptune, New Jersey 07754
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Yale University
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Yale - New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut 06504
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Tulane University School of Medicine
New Orleans, Louisiana 70112
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Ochsner Clinic Foundation
New Orleans, Louisiana 70121
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Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York 10003
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AIDS Community Research Initiative of America (ACRIA)
New York, New York 10018
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Dr. Howard A. Grossman, M.D.
New York, New York 10107
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Research Across America
New York, New York 10022
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Saint Michael's Medical Center
Newark, New Jersey 07102
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Orange Coast Medical Group
Newport Beach, California 92663
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Circle CARE Center, LLC
Norwalk, Connecticut 06851
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Univ of Nebraska Med Ctr
Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Desert Oasis Healthcare Medical Group
Palm Springs, California 92262
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Infectious Diseases Associates of Northwest Florida, PA
Pensacola, Florida 32504
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AIDS Care
Rochester, New York 14607
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University of California Davis Research
Sacramento, California 95814
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TICON I Research Clinic (DEXA Scan only)
Sacramento, California 95817
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Kaiser Hospital Sacramento
Sacramento, California 95825
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Investigational Drugs Pharmacy
San Francisco, California 94118
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Kaiser Permanente - Clinical Trials Unit
San Francisco, California 94118
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Synarc Inc.
San Francisco, California 94105
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Kaiser Permanente Santa Clara
Santa Clara, California 95051
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Swedish Medical Center
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts 01199
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University of South Florida Health - HIV Clinical Research Unit
Tampa, Florida 33602
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Infectious Disease Research Institute, Inc.
Tampa, Florida 33614
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Osteoporosis Care Center
Tampa, Florida 33614
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St. Joseph's Hospital Diagnostic Center
Tampa, Florida 33067
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Quest Diagnostic Laboratory
Tampa, Florida 33614
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University of Toledo Medical Center
Toledo, Ohio 43614
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Kaiser Permanente
Union City, California 94587
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Capital Medical Associates, PC
Washington, District of Columbia 20036
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George Washington University Medical Faculty Associates
Washington, District of Columbia 20037
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Rowan Tree Medical, P.A.
Wilton Manors, Florida 33305
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