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

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

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

Inclusion Criteria:

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

- 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

- CXCR4 using virus detected using randomized tropism determination or repeated failure
to obtain an interpretable tropism result.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The proportion of subjects with plasma HIV 1 RNA <50 copies/mL at Week 48.

Outcome Time Frame:

Week 48

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • HIV-1
  • Double-blind
  • comparative
  • trial
  • maraviroc
  • versus
  • emtricitabine/tenofovir
  • both with darunavir/ritonavir
  • antiretroviral-naive
  • Ccr5 tropic
  • Hiv 1
  • patients.



AIDS Research Consortium of Atlanta Atlanta, Georgia  30308
Infectious Disease Specialists of Atlanta Decatur, Georgia  30033
Tulane University School of Medicine New Orleans, Louisiana  70112
New York Medical College Valhalla, New York  10595
Cedars-Sinai Medical Center Los Angeles, California  90048
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Ochsner Clinic Foundation New Orleans, Louisiana  70121
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Northwestern University Chicago, Illinois  60611
Swedish Medical Center Seattle, Washington  98122-4307
Hennepin County Medical Center Minneapolis, Minnesota  
Henry Ford Health System Detroit, Michigan  48202
Yale University New Haven, Connecticut  06520
Wayne State University Detroit, Michigan  48202
Kaiser Permanente Sacramento, California  
Erie County Medical Center Buffalo, New York  14215
Jersey Shore University Medical Center Neptune, New Jersey  07754
Research Across America New York, New York  10021
Saint Michael's Medical Center Newark, New Jersey  07102
Miami Research Associates Miami, Florida  33173
Kaiser Permanente of Colorado Aurora, Colorado  80014
Howard Brown Health Center Chicago, Illinois  60613
George Washington University Medical Faculty Associates Washington, District of Columbia  20037
Orange Coast Medical Group Newport Beach, California  92663
The Kinder Medical Group Miami, Florida  33133
Wohlfeiler, Piperato and Associates, LLC Miami Beach, Florida  33139
Infectious Disease Research Institute, Inc. Tampa, Florida  33614
Central Texas Clinical Research Austin, Texas  78705
Therapeutic Concepts, PA Houston, Texas  77004
Baystate Infectious Diseases Clinical Research Springfield, Massachusetts  01199
University of Alabama at Birmingham - 1917 Research Clinic Birmingham, Alabama  35294
Health Services Center Hobson City, Alabama  36201
Dr. Anthony Mills, MD, Inc. Los Angeles, California  90069
Desert Oasis Healthcare Medical Group Palm Springs, California  92262
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group Palm Springs, California  92262
Kaiser Hospital Sacramento Sacramento, California  95825
University of California Davis Research Sacramento, California  95814
TICON I Research Clinic (DEXA Scan only) Sacramento, California  95817
Investigational Drugs Pharmacy San Francisco, California  94118
Kaiser Permanente - Clinical Trials Unit San Francisco, California  94118
Kaiser Permanente Santa Clara Santa Clara, California  95051
University of Colorado Denver - University of Colorado Hospital Aurora, Colorado  80045
Yale - New Haven Hospital Nathan Smith Clinic New Haven, Connecticut  06504
Circle CARE Center Norwalk, Connecticut  06851
Capital Medical Associates, PC Washington, District of Columbia  20036
Broward Health - Comprehensive Care Center Fort Lauderdale, Florida  33311
University of Miami AIDS Clinical Research Unit Miami, Florida  33136
Community AIDS Resource Inc dba Care Resource Miami, Florida  33137
UMHC/Sylvester Comprehensive Cancer Center Miami, Florida  33136
University of Miami - IDCRU Miami, Florida  33136
Infectious Diseases Associates of Northwest Florida, PA Pensacola, Florida  32504
Quest Diagnostic Laboratory Tampa, Florida  33614
University of South Florida Health-HIV Clinical Research Unit Tampa, Florida  33602
St. Joseph's Hospital Diagnostic Center Tampa, Florida  33067
Osteoporosis Care Center Tampa, Florida  33614
Rowan Tree Medical, PA Wilton Manors, Florida  33305
Northwestern University/NMH Chicago, Illinois  60611
University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease Iowa City, Iowa  52242
Be Well Medical Center, PC Berkley, Michigan  48072
University Physicians Group Detroit, Michigan  48201
Michigan State University College of Osteopathic Medicine - Department of Internal Medicine East Lansing, Michigan  48824
Ingham County Health Department Lansing, Michigan  48911
Kansas City Free Health Clinic Kansas City, Missouri  64111
Beth Israel Medical Center - AIDS Clinical Trials Unit New York, New York  10003
AIDS Community Research Initiative of America (ACRIA) New York, New York  10018
Dr. Howard A. Grossman, M.D. New York, New York  10107
AIDS Care Rochester, New York  14607
I.D. Consultants, P.A. Charlotte, North Carolina  28209
East Carolina University Division of Infectious Diseases Greenville, North Carolina  27834
University of Cincinnati - Department of Internal Medicine Cincinnati, Ohio  45267
The University of Toledo Medical Center Toledo, Ohio  43614
North Texas Infectious Diseases Consultants, PA Dallas, Texas  75246
The Office of Dr. Gordon E. Crofoot, M.D., PA Houston, Texas  77098
Research Access Network Houston, Texas  77098