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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
N/A
Open (Enrolling)
Both
HIV-1

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
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.

Type of Study:

Interventional

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:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4001095

NCT ID:

NCT01345630

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.

Name

Location

AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Infectious Disease Specialists of AtlantaDecatur, Georgia  30033
Tulane University School of MedicineNew Orleans, Louisiana  70112
New York Medical CollegeValhalla, New York  10595
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Northwestern UniversityChicago, Illinois  60611
Swedish Medical CenterSeattle, Washington  98122-4307
Hennepin County Medical CenterMinneapolis, Minnesota  
Henry Ford Health SystemDetroit, Michigan  48202
Yale UniversityNew Haven, Connecticut  06520
Wayne State UniversityDetroit, Michigan  48202
Kaiser PermanenteSacramento, California  
Erie County Medical CenterBuffalo, New York  14215
Jersey Shore University Medical CenterNeptune, New Jersey  07754
Research Across AmericaNew York, New York  10021
Saint Michael's Medical CenterNewark, New Jersey  07102
Miami Research AssociatesMiami, Florida  33173
Kaiser Permanente of ColoradoAurora, Colorado  80014
Howard Brown Health CenterChicago, Illinois  60613
George Washington University Medical Faculty AssociatesWashington, District of Columbia  20037
Orange Coast Medical GroupNewport Beach, California  92663
The Kinder Medical GroupMiami, Florida  33133
Wohlfeiler, Piperato and Associates, LLCMiami Beach, Florida  33139
Infectious Disease Research Institute, Inc.Tampa, Florida  33614
Central Texas Clinical ResearchAustin, Texas  78705
Therapeutic Concepts, PAHouston, Texas  77004
Baystate Infectious Diseases Clinical ResearchSpringfield, Massachusetts  01199
University of Alabama at Birmingham - 1917 Research ClinicBirmingham, Alabama  35294
Health Services CenterHobson City, Alabama  36201
Dr. Anthony Mills, MD, Inc.Los Angeles, California  90069
Desert Oasis Healthcare Medical GroupPalm Springs, California  92262
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical GroupPalm Springs, California  92262
Kaiser Hospital SacramentoSacramento, California  95825
University of California Davis ResearchSacramento, California  95814
TICON I Research Clinic (DEXA Scan only)Sacramento, California  95817
Investigational Drugs PharmacySan Francisco, California  94118
Kaiser Permanente - Clinical Trials UnitSan Francisco, California  94118
Kaiser Permanente Santa ClaraSanta Clara, California  95051
University of Colorado Denver - University of Colorado HospitalAurora, Colorado  80045
Yale - New Haven Hospital Nathan Smith ClinicNew Haven, Connecticut  06504
Circle CARE CenterNorwalk, Connecticut  06851
Capital Medical Associates, PCWashington, District of Columbia  20036
Broward Health - Comprehensive Care CenterFort Lauderdale, Florida  33311
University of Miami AIDS Clinical Research UnitMiami, Florida  33136
Community AIDS Resource Inc dba Care ResourceMiami, Florida  33137
UMHC/Sylvester Comprehensive Cancer CenterMiami, Florida  33136
University of Miami - IDCRUMiami, Florida  33136
Infectious Diseases Associates of Northwest Florida, PAPensacola, Florida  32504
Quest Diagnostic LaboratoryTampa, Florida  33614
University of South Florida Health-HIV Clinical Research UnitTampa, Florida  33602
St. Joseph's Hospital Diagnostic CenterTampa, Florida  33067
Osteoporosis Care CenterTampa, Florida  33614
Rowan Tree Medical, PAWilton Manors, Florida  33305
Northwestern University/NMHChicago, Illinois  60611
University of Iowa, University of Hospitals and Clinics - Division of Infectious DiseaseIowa City, Iowa  52242
Be Well Medical Center, PCBerkley, Michigan  48072
University Physicians GroupDetroit, Michigan  48201
Michigan State University College of Osteopathic Medicine - Department of Internal MedicineEast Lansing, Michigan  48824
Ingham County Health DepartmentLansing, Michigan  48911
Kansas City Free Health ClinicKansas City, Missouri  64111
Beth Israel Medical Center - AIDS Clinical Trials UnitNew 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 CareRochester, New York  14607
I.D. Consultants, P.A.Charlotte, North Carolina  28209
East Carolina University Division of Infectious DiseasesGreenville, North Carolina  27834
University of Cincinnati - Department of Internal MedicineCincinnati, Ohio  45267
The University of Toledo Medical CenterToledo, Ohio  43614
North Texas Infectious Diseases Consultants, PADallas, Texas  75246
The Office of Dr. Gordon E. Crofoot, M.D., PAHouston, Texas  77098
Research Access NetworkHouston, Texas  77098