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
18 Years
N/A
Open (Enrolling)
Both
HIV-1
Both
HIV-1
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 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 |
