Expanded Access Program for Maraviroc At Multiple Centers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00426660
First received: January 22, 2007
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Condition Intervention Phase
HIV Infections
Drug: maraviroc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.

  • Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.

  • Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.

  • Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.

  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.


Secondary Outcome Measures:
  • Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]

    Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.

    Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.


  • Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

  • Change From Baseline in CD4 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD4 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD8 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD8 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Median Time to Virologic Failure [ Time Frame: Day 1 up to Week 144 ] [ Designated as safety issue: No ]
    Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.

  • Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.

  • Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure [ Time Frame: Screening up to Week 144 ] [ Designated as safety issue: No ]
    Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.

  • Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.

  • Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.


Enrollment: 1047
Study Start Date: February 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: maraviroc
The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
  • Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
  • Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion Criteria:

  • Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426660

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama
Birmingham, Alabama, United States, 35294-2050
Health Services Center
Hobson City, Alabama, United States, 36201
United States, Arizona
El Rio, Special Immunology Associates
Tucson, Arizona, United States, 85745
United States, Arkansas
Thomas T Jefferson, MD
Little Rock, Arkansas, United States, 72207
Health for Life Clinic PLLC
Little Rock, Arkansas, United States, 72207
United States, California
Vista Medical
Beverly Hills, California, United States, 90210-4212
AHF Research Center
Beverly Hills, California, United States, 90211
Orange County Center for Special Immunology
Fountain Valley, California, United States, 92708
Kaiser Permanente
Hayward, California, United States, 94545
Living Hope Clinical Trials
Long Beach, California, United States, 90813
Office of Anthony Mills, MD
Los Angeles, California, United States, 90069
Kaiser Permanente Medical Center
Los Angeles, California, United States, 90027
Robert Bolan, MD
Los Angeles, California, United States, 90028
Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology
Los Angeles, California, United States, 90033
Peter J. Ruane, M.D. Inc.
Los Angeles, California, United States, 90036
Synergy Hematology-Oncology Associates
Los Angeles, California, United States, 90036
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
AltaMed Health Services Corporation
Los Angeles, California, United States, 90022
Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.
Los Angeles, California, United States, 90048
Office of Dr. Salah Bibi, MD
Modesto, California, United States, 95350
Bonnie V Bock MD
Newport Beach, California, United States, 92663
Alta Bates Summit Medical Center
Oakland, California, United States, 94609
Desert Medical Group, Clinical Research Center
Palm Springs, California, United States, 92262
Riverside Medical Clinic
Riverside, California, United States, 92506
Sutter Medical Group
Sacramento, California, United States, 95816
Fort Sutter Medical Complex
Sacramento, California, United States, 95816
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Quest Clinical Research
San Francisco, California, United States, 94115-3029
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente Santa Clara
Santa Clara, California, United States, 95051
Shared Medical Research Foundation
Tarzana, California, United States, 91356
Tarzana Treatment Center
Tarzana, California, United States, 91356
Bipin Bhagat MD Inc.
Victorville, California, United States, 92395
United States, Colorado
Kaiser Permanente Colorado
Denver, Colorado, United States, 80205
Kaiser Permanente of Colorado
Denver, Colorado, United States, 80205
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States, 80220
Kaiser Permanente of Colorado
Lafayette, Colorado, United States, 80026
United States, Connecticut
Connecticut Health Care Group
Glastonbury, Connecticut, United States, 06033
Infectious Disease Clinic
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
United States, Florida
Internal Medicine Associates of Lee County
Bonita Springs, Florida, United States, 34134
Infectious Disease Research Corp
Boynton Beach, Florida, United States, 33426
Internal Medicine Associates of Lee County
Cape Coral, Florida, United States, 33990
Daniel Warner M.D., P.A. Consultive Medicine
Daytona Beach, Florida, United States, 32117
Northpoint Medical, PA
Fort Lauderdale, Florida, United States, 33308
Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
Office of Gary J. Richmond, MD
Fort Lauderdale, Florida, United States, 33316
Internal Medicine Associates of Lee County
Fort Myers, Florida, United States, 33912
Therafirst Medical Centers
Ft. Lauderdale, Florida, United States, 33308
Sunshine Medical Institute
Hollywood, Florida, United States, 33021
Osler Medical Inc.
Melbourne, Florida, United States, 32901
Steinhart Medical Associates
Miami, Florida, United States, 33133
Care Resource
Miami, Florida, United States, 33137
Office of Albert Canas, MD
Miami Beach, Florida, United States, 33139
Donald Johnson, MD
North Miami Beach, Florida, United States, 33162
Wohlfeiler, Piperato & Associates, LLC
North Miami Beach, Florida, United States, 33169
Infectious Diseases of Central Florida
Orlando, Florida, United States, 32806
Orlando Immunology Center
Orlando, Florida, United States, 32803
Associates in Infectious Diseases
Port St. Lucie, Florida, United States, 34952
Barry Rodwick, MD
Safety Harbor, Florida, United States, 34695
Infectious Diseases Associates
Sarasota, Florida, United States, 34239
University Hepatitis Center at Bach & Godofsky, MD,PA
Sarasota, Florida, United States, 34243
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Eric Nicholson, M.D., P.A.
Tallahassee, Florida, United States, 32308
University of Sout Florida
Tampa, Florida, United States, 33612
Midtown Medical Center
Tampa, Florida, United States, 33614
University of South Florida
Tampa, Florida, United States, 33606
Donald Watren MD
West Palm Beach, Florida, United States, 33401
United States, Georgia
Kaiser Permanente
Atlanta, Georgia, United States, 30339
Philip Brachman MD
Atlanta, Georgia, United States, 30309
Midtown West Medical
Atlanta, Georgia, United States, 30318
Absolute CARE
Atlanta, Georgia, United States, 30329
Family Health Care of Atlanta
Atlanta, Georgia, United States, 30318-2513
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Kaiser Permanente
Jonesboro, Georgia, United States, 30236
Infectious Diseases Associates, PC
Riverdale, Georgia, United States, 30274
Chatham County Health Department
Savannah, Georgia, United States, 31405
Infectious Disease Consultants
Tucker, Georgia, United States, 30084-8128
United States, Illinois
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Roger Trinh
Chicago, Illinois, United States, 60613
Northstar Medical Center
Chicago, Illinois, United States, 60657
United States, Kansas
Cotton-O'Neil Clinic
Topeka, Kansas, United States, 66606-1670
Kansas University Internal Medicine Midtown Clinic
Wichita, Kansas, United States, 67214
Via Christi Research, Inc.
Wichita, Kansas, United States, 67214
United States, Maryland
Chase Brexton Health Services Inc
Baltimore, Maryland, United States, 21201
Metro Health Care
Greenbelt, Maryland, United States, 20770-3525
Dr.'s Alpert, Trinh, and Posorske
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Fenway Community Health
Boston, Massachusetts, United States, 02115
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215-3318
Community Research Initiative of New England
Springfield, Massachusetts, United States, 01107
United States, Michigan
The Office of Dr. Paul A. Benson, DO
Berkley, Michigan, United States, 48072
Private Practice (Dr. Gregory Kuldanek)
Grand Rapids, Michigan, United States, 49546
St. John hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Private Practice
Keego Harbor, Michigan, United States, 48320
MSU Adult Medicine, 10
Lansing, Michigan, United States, 48910
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Nemechek Health Renewal
Kansas City, Missouri, United States, 64111
Private Practice (Dr. Mark Scheperle)
St. Louis, Missouri, United States, 63117
United States, Montana
Partnership Health Center
Missoula, Montana, United States, 59802
United States, New Jersey
CPMC Research Pharmacy
Englewood, New Jersey, United States, 07631
Leonia Medical Associates
Englewood, New Jersey, United States, 07631
Center for Infectious Diseaes
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
UMDNJ
Newark, New Jersey, United States, 07103
University Hospital
Newark, New Jersey, United States, 07103
Newark Community Health Center
Newark, New Jersey, United States, 07114
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
Premier Medical Research Group
Toms River, New Jersey, United States, 08755
Garden State Infectious Disease Associates, PA
Voorhees, New Jersey, United States, 08043
United States, New York
Upstate Infectious Disease Associates
Albany, New York, United States, 12208
Allmed Medical and Rehabilitaion of NY
Bronx, New York, United States, 10454
Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Woodhull Medical Center
Brooklyn, New York, United States, 11206
New York Methodist Hospital
Brooklyn, New York, United States, 11215
NYM Medical Pavilion
Brooklyn, New York, United States, 11215
Chiu-Bin Hsiao, MD
Buffalo, New York, United States, 14215
The Office of Dr. Zale P. Bernstein, MD.
Buffalo, New York, United States, 14215
NYHQ
Flushing, New York, United States, 11367
Schneider Children's Hospital
Great Neck, New York, United States, 11042
North Shore University Hospital, Department of Infectious Disease
Manhasset, New York, United States, 11030
Perion Smith
New York, New York, United States, 10018
Beth Israel Medical Center
New York, New York, United States, 10003
Paul Bellman, MD
New York, New York, United States, 10003
Sidney Hillman Family Health Center
New York, New York, United States, 10003
Ricky Hsu
New York, New York, United States, 10011
Bellevue Hospital
New York, New York, United States, 10016
NYU School of Medicine
New York, New York, United States, 10016
New York-Presbyterian Hospital
New York, New York, United States, 10032
James I Jones Jr, MD
New York, New York, United States, 10019-1819
Sharon Lewin MD and Michael Rendel MD
New York, New York, United States, 10024
Lenox Ave Clinic
New York, New York, United States, 10026
Astor Medical Group, LLP
New York, New York, United States, 10003
Mount Sinai Medical Center
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York, New York, United States, 10029
Harlem Medical Associates
New York, New York, United States, 10029
Dr. Steven Fine
Rochester, New York, United States, 14605
Jordon Glaser, MD
Stanton Island, New York, United States, 10304
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
ID Associates
Gastonia, North Carolina, United States, 28054
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
United States, Ohio
Metro Health Systems
Cleveland, Ohio, United States, 44109
South Dayton Acute Care Consultants Inc.
Dayton, Ohio, United States, 45429
University of Toledo - Health Science Campus
Toledo, Ohio, United States, 43614-5812
United States, Oklahoma
University of Oklahoma - Schusterman Clinic
Tulsa, Oklahoma, United States, 74135
United States, Oregon
The Research & Education Group
Portland, Oregon, United States, 97210
Kaiser Permanente-Northwest Region, Immune Deficiency Clinic
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18102
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
RPS Infectious Diseases
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Investigational Drug Services
Charleston, South Carolina, United States, 29401
United States, Tennessee
Infectious Disease Associates of Memphis
Memphis, Tennessee, United States, 38119
United States, Texas
The Office of Dr. Nicholaos C. Bellos, MD
Dallas, Texas, United States, 75204
The Office of Dr. Patrick W. Daly, MD.
Dallas, Texas, United States, 75219
The Office of Dr. Susan M. Diamond, MD.
Dallas, Texas, United States, 75231
La Fe CARE Center Clinic
El Paso, Texas, United States, 79925
Kelly, Allan Rowman MD
Fort Worth, Texas, United States, 76104-3048
Tarrant County Infectious Disease Associates
Ft. Worth, Texas, United States, 76104
Fernando Garcia, MD
Harlingen, Texas, United States, 78550
The Office of Dr. Gordon E. Crofoot, MD.
Houston, Texas, United States, 77098
Harris County Hospital District
Houston, Texas, United States, 77009
Thomas Street Clinic
Houston, Texas, United States, 77009
Diversified Medical Practices, PA
Houston, Texas, United States, 77027
Baylor College of Medicine
Houston, Texas, United States, 77030
Brewton, Gary W MD
Houston, Texas, United States, 77098-2807
Research Access Network
Houston, Texas, United States, 77098
The University of Texas Health Sciences Center at Houston
Houston, Texas, United States, 77030
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Diagnostic Clinic of Longview, PA
Longview, Texas, United States, 75605
Dr. James Bromley
San Antonio, Texas, United States, 78212
Responsive ID Solutions
San Antonio, Texas, United States, 78258
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases
Annandale, Virginia, United States, 22003
Infectious Diseases
Arlington, Virginia, United States, 22205-3633
Infectious Diseases Associates of Central Virginia
Danville, Virginia, United States, 24541
Infectious Disease Consultants
Fairfax, Virginia, United States, 22030
Hampton Roads Medical Specialists
Hampton, Virginia, United States, 23666
Barbara Cassie
Lynchburg, Virginia, United States, 24501
Crossover Ministry
Richmond, Virginia, United States, 23224
United States, Washington
William F. Ehni, MD
Edmonds, Washington, United States, 98026
Emerald City Medical Arts
Seattle, Washington, United States, 98109
Group Health Cooperative
Seattle, Washington, United States, 98112
The Office of Dr. Daniel R. Coulston, MD
Spokane, Washington, United States, 99204
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, United States, 98664
United States, West Virginia
CAMC Memorial Hospital
Charleston, West Virginia, United States, 25304
Clinical Trials Center
Charleston, West Virginia, United States, 25304
University Physicians Internal Medicine
Huntington, West Virginia, United States, 25701
Argentina
Fundacion Huesped, Departamento de Investigacion Clinica
Buenos Aires, Argentina, C1202ABB
FUNCEI
Buenos Aires, Argentina, C1425AWK
Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Albion Street Centre
Surry Hills, New South Wales, Australia, 2010
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
AIDS Medical Centre
Brisbane, Queensland, Australia, 4000
Infectious Diseases Unit
Herston, Queensland, Australia, 4029
Australia, South Australia
Infectious Diseases Unit
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Clinical Research Unit, Infectious Diseases
Melbourne, Victoria, Australia, 3004
Northside Clinic
North Fitzroy, Victoria, Australia, 3068
Prahran Market Clinic
South Yarra, Victoria, Australia, 3141
Austria
Allgemeines Krankenhaus Wien
A-1090, Austria
Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1
Graz, Austria, A-8020
Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung
Wien, Austria, A-1140
Belgium
Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde
Antwerpen, Belgium, 2000
Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses
Bruxelles, Belgium, 1000
Cliniques Universitaires Saint-Luc, Maladies Infectieuses
Bruxelles, Belgium, 1200
Hôpital Erasme, Médecine Interne
Bruxelles, Belgium, 1070
Centre Hospitalier Universitaire de Charleroi, Médecine Interne
Charleroi, Belgium, 6000
Universitair Ziekenhuis Gent, Inwendige Geneeskunde
Gent, Belgium, 9000
Academisch Ziekenhuis VUB
Jette, Belgium, B-1090
Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
Leuven, Belgium, 3000
CHU Sart-Tilman, Medecine Interne
Liège, Belgium, 4000
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, Canada, M5B 1L6
Canada, Quebec
Clinique médicale l'Actuel
Montreal, Quebec, Canada, H2L 4P9
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
CHUM Hôtel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Projet L.O.R.I.
Montreal, Quebec, Canada, H3H 1V1
Chile
Hospital Clínica Universidad Católica
Santiago, RM, Chile, 8330023
Hospital Clínico San Borja Arriarán
Santiago, RM, Chile, 8360160
Costa Rica
Fundación para el Desarrollo de la Lucha contra el SIDA
Barrio Aranjuez, San Jose, Costa Rica
Dominican Republic
Instituto Dominicano de Estudios Virologicos
Santo Domingo, Dominican Republic
France
Hopital Sainte Marguerite
Marseille, Cedex 09, France, 13274
Hopital Saint Antoine
Paris, Cedex 12, France, 75571
Centre Hospitalier Universitaire de Caen
Caen, Cedex, France, 14033
Hôpital Saint Jacques
Besancon, France, 25030
Hopital Avicenne
Bobigny Cedex, France, 93009
Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne
Bordeaux, France, 33076
Hôpital Saint-andré
Bordeaux Cedex, France, 33075
Hopital Gabriel Montpied
Clermont Ferrand, France, 63000
CHU Michallon
Grenoble Cedex 09, France, 38043
Hopital La Source
La Source, France, 45100
Hopital de Bicêtre
Le Kremlin Bicêtre, France, 94270
Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie
Lyon Cedex 02, France, 69288
Hôpital de la Croix Rousse
Lyon Cedex 04, France, 690317
Hopital Gui de Chauliac
Montpellier, France, 34295
CHU de Nantes - Hopital Hotel Dieu
Nantes, France, 44093
Hopital de l Archet 1
Nice Cedex 3, 06, France, 06202
Hopital Europeen George Pompidou
Paris, France, 75015
Hopital Tenon, Service des Maladies Infectieuses
Paris, France, 75020
Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses
Paris, France, 75018
Hôpital de la Pitié Salpétrière
Paris, France, 75013
Hopital Saint-Louis
Paris Cedex 10, France, 75475
Centre Hospitalier Cochin Saint Vincent de Paul
Paris CEDEX 14, France, 75679
Hôpital Necker-Service des Maladies Infectieuses et Tropicales
Paris cedex 15, France, 75743
Chu Pontchaillou, Service des maladies infectieuses
Rennes, France, 35033
Hôpital de Purpan
Toulouse, France, 31059
CHU de Tourcoing
Tourcoing, France, 59208
Hopital Paul Brousse
Villejuif, France, 94800
Germany
Praxisgemeinschaft Bieniek & Cordes
Berlin, Germany, 10243
Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
Dresden, Germany, 01307
Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik
Essen, Germany, 45122
Gemeinschaftspraxis Dres. Rump und Usadel
Freiburg, Germany, 79098
Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin
Hannover, Germany, 30625
Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,
Koeln, Germany, 50937
Greece
Evagelismos Hospital
Athens, Attiki, Greece, 10676
Greek Red Cross Hospital
Athens, Attiki, Greece, 115 26
General Hospital of Athens G. Gennimatas
Athens, Greece, 115 27
Andreas Sygros Hospital
Athens, Greece, 161 21
University Hospital of Patras
Patras, Greece, 265 00
Regional General Hospital Tzaneio
Piraeus, Greece, 185 36
AHEPA Hospital
Thessaloniki, Greece, 54636
Hong Kong
Department of Medicine Queen Elizabeth Hospital
Kowloon, Hong Kong
India
Department of Medicine, St. John's Medical College Hospital
Bangalore, Karnataka, India, 560 034
Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India, 400 026
YR Gaitonde Centre for AIDS Research and Education (YRG CARE)
Chennai, Tamil Nadu, India, 600 113
Ireland
Catherine McAuley Centre
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Italy
Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico
Bari, Italy, 70124
Unita' Operativa Malattie Infettive
Bologna, Italy, 40138
Istituto di Malattie Infettive e Tropicali
Brescia, Italy, 25123
Unita' Operativa di Malattie Infettive
Catania, Italy, 95126
Presidio Ospedaliero SS Annunziata
Chieti Scalo, Italy, 66100
Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy, 44100
SOD Malattie Infettive, La Piastra dei Servizi
Firenze, Italy, 50100
Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive
Genova, Italy, 16132
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20127
Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive
Milano, Italy, 20157
Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia
Modena, Italy, 41100
Unita Operativa di Malattie Infettive e Tropicali
Padova, Italy, 35128
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Reparto di Malattie Infettive, Azienda Sanitaria Locale
Pescara, Italy, 65124
Azienda Ospedaliera San Giovanni Addolorata
Roma, Italy, 00184
Policlinico Tor Vergata, Divisione Malattie Infettive
Roma, Italy, 00133
IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive
Roma, Italy, 00149
IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive
Roma, Italy, 00149
Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza
Roma, Italy, 00161
Universita'Cattolica del Sacro Cuore Policlinico Gemelli
Roma, Italy, 00168
IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive
Roma, Italy, 00149
Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia
Torino, Italy, 10149
Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.
Torrette di Ancona, Italy, 60121
Unita' Operativa di Malattie Infettive
Venezia, Italy, 30122
Malaysia
Physician Clinic
Kota Bharu, Kelantan, Malaysia, 15586
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia, 47000
Mexico
Hospital Regional Lic. Adolfo Lopez Mateos
Mexico, DF, Mexico, 01030
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280
Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran
Tlalpan, Mexico Df, Mexico, CP 14000
Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, NL 3584 CX
Portugal
Centro Hospitalar de Cascais
Cascais, Portugal, 2750-349
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
Lisboa, Portugal, 1169-050
Hospital Sta. Maria
Lisbon, Portugal, 1649-035
Hospital São João
Porto, Portugal, 4200-319
Puerto Rico
Centro Ararat Inc
Ponce, Puerto Rico, 00717-1563
HOPE Clinical Research
San Juan, Puerto Rico, 00909
Romania
Institutul de Boli Infectioase "Prof. Matei Bals"
Bucuresti, Sector 2, Romania, 021105
Spitalul de Boli Infectioase si Tropicale Victor Babes
Bucharest, Romania, 030303
Spitalul Clinic de Boli Infectioase Constanta
Constanta, Romania, 900709
Spitalul Clinic de Boli Infectioase Sf. Parascheva
Iasi, Romania, 700116
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03202
H. Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital General de Granollers
Granollers, Barcelona, Spain, 08400
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Basurto
Basurto, Bilbao, Spain, 48078
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital de Cabueñes
Cabueñes, Gijon, Spain, 33394
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain, 15706
Complejo Hospitalario Xeral-Cies
Vigo, Pontevedra, Spain, 36204
Hospital Donostia-Donostia Ospitalea
Donostia, San Sebastian, Spain, 20014
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Hospital de Tortosa Verge de La Cinta
Tortosa, Tarragona, Spain, 43500
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Del Mar
Barcelona, Spain, 08003
Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Puerta Del Mar
Cadiz, Spain, 11009
Hospital Universitario Reina Sofia
Cordoba, Spain, 14012
Hospital Universitario San Cecilio
Granada, Spain, 18012
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Hospital Carlos Iii
Madrid, Spain, 28029
Hospital General Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital 12 de Octubre
Madrid, Spain, 28041
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Complejo Hospitalario Carlos Haya
Malaga, Spain, 29010
Hospital Virgen de La Victoria
Malaga, Spain, 29010
Hospital Costa Del Sol
Malaga, Spain, 29600
Hospital Virgen Del Rocio
Sevilla, Spain, 41013
Complejo Hospitalario Nuestra Señora de Valme
Sevilla, Spain, 41014
Hospital Universitario Virgen de La Macarena
Sevilla, Spain, 41071
Hospital Universitario La Fe
Valencia, Spain, 46009
Hospital Clinico Universitario
Valencia, Spain, 46010
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Taiwan
Department of Infectious Disease, E-Da Hospital
Kaohsiung County, Taiwan, 824
United Kingdom
Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre
Brighton, Sussex, United Kingdom, BN2 1ES
North Manchester General Hospital
Crumpsall, Manchester, United Kingdom, M8 6RB
Regional Infectious Diseases Unit
Edinburgh, United Kingdom, EH4 2XU
Ian Charleson Centre
London, United Kingdom, NW3 2QG
Department of Sexual Health
London, United Kingdom, SE5 9RS
St Stephens Research Ltd
London, United Kingdom, SW10 9NH
Imperial College
London, United Kingdom, W2 1NY
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00426660     History of Changes
Obsolete Identifiers: NCT02783001
Other Study ID Numbers: A4001050  2006-004306-50  EAP 
Study First Received: January 22, 2007
Results First Received: June 2, 2011
Last Updated: May 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 28, 2016