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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Central Texas Clinical Research
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
Click here to add this to my saved trials
Howard Brown Health Center
4025 North Sheridan Road
Chicago, Illinois 60613
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
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...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
AIDS Research Consortium of Atlanta
Atlanta, Georgia 30308
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
University of Colorado Denver - University of Colorado Hospital
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Be Well Medical Center
Berkley, Michigan 48072
?
mi
from
Berkley, MI
Click here to add this to my saved trials
University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Erie County Medical Center
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
I.D. Consultants, P.A.
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Northwestern University/NMH
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Northwestern University
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
University of Cincinnati - Department of Internal Medicine
Cincinnati, Ohio 45267
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas Diabetes and Endocrine Center
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
East Sydney Doctors
Darlinghurst, New South Wales 2007
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
Infectious Disease Specialists of Atlanta
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
DeKalb Medical Diagnostic Breast Center
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Kaiser Permanente of Colorado
Denver, Colorado 80205
?
mi
from
Denver, CO
Click here to add this to my saved trials
University Physicians Group
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Henry Ford Health System
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
East Lansing, Michigan 48824
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
Biomedical and Health Institutional Review Board
East Lansing, Michigan 48825
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
Broward Health - Comprehensive Care Center
Fort Lauderdale, Florida 33311
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Broward General Medical Center
Fort Lauderdale, Florida 33316
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
East Carolina University Division of Infectious Diseases
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
(DEXA Scan Facility) East Carolina University Brody Outpatient Center
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Kaiser Permanente
Hayward, California 94545
?
mi
from
Hayward, CA
Click here to add this to my saved trials
Health Services Center
Hobson City, Alabama 36201
?
mi
from
Hobson City, AL
Click here to add this to my saved trials
Therapeutic Concepts, P.A.
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Research Access Network
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
The Office of Dr. Gordon E. Crofoot, M.D., PA
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Kansas City Free Health Clinic
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Ingham County Health Department
Lansing, Michigan 48911
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Anthony Mills MD Inc
Los Angeles, California 90069
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
University of Miami AIDS Clinical Research Unit
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
The Kinder Medical Group
Miami, Florida 33133
?
mi
from
Miami, FL
Click here to add this to my saved trials
Community AIDS Resource Inc dba Care Resource
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
UMHC/Sylvester Comprehensive Cancer Center
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Research Associates
Miami, Florida
?
mi
from
Miami, FL
Click here to add this to my saved trials
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida 33139
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
Hennepin County Medical Center
Minneapolis, Minnesota 55414
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Jersey Shore University Medical Center
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
Brandywine Common
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Yale - New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut 06504
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Tulane University School of Medicine
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York 10003
?
mi
from
New York, NY
Click here to add this to my saved trials
AIDS Community Research Initiative of America (ACRIA)
New York, New York 10018
?
mi
from
New York, NY
Click here to add this to my saved trials
Dr. Howard A. Grossman, M.D.
New York, New York 10107
?
mi
from
New York, NY
Click here to add this to my saved trials
Research Across America
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
Saint Michael's Medical Center
Newark, New Jersey 07102
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Orange Coast Medical Group
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Circle CARE Center, LLC
Norwalk, Connecticut 06851
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Univ of Nebraska Med Ctr
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Desert Oasis Healthcare Medical Group
Palm Springs, California 92262
?
mi
from
Palm Springs, CA
Click here to add this to my saved trials
Infectious Diseases Associates of Northwest Florida, PA
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
AIDS Care
Rochester, New York 14607
?
mi
from
Rochester, NY
Click here to add this to my saved trials
University of California Davis Research
Sacramento, California 95814
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
TICON I Research Clinic (DEXA Scan only)
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Kaiser Hospital Sacramento
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Investigational Drugs Pharmacy
San Francisco, California 94118
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Kaiser Permanente - Clinical Trials Unit
San Francisco, California 94118
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Synarc Inc.
San Francisco, California 94105
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Kaiser Permanente Santa Clara
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
University of South Florida Health - HIV Clinical Research Unit
Tampa, Florida 33602
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Infectious Disease Research Institute, Inc.
Tampa, Florida 33614
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Osteoporosis Care Center
Tampa, Florida 33614
?
mi
from
Tampa, FL
Click here to add this to my saved trials
St. Joseph's Hospital Diagnostic Center
Tampa, Florida 33067
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Quest Diagnostic Laboratory
Tampa, Florida 33614
?
mi
from
Tampa, FL
Click here to add this to my saved trials
University of Toledo Medical Center
Toledo, Ohio 43614
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Kaiser Permanente
Union City, California 94587
?
mi
from
Union City, CA
Click here to add this to my saved trials
Capital Medical Associates, PC
Washington, District of Columbia 20036
?
mi
from
Washington,
Click here to add this to my saved trials
George Washington University Medical Faculty Associates
Washington, District of Columbia 20037
?
mi
from
Washington,
Click here to add this to my saved trials
Rowan Tree Medical, P.A.
Wilton Manors, Florida 33305
?
mi
from
Wilton Manors, FL
Click here to add this to my saved trials