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Expanded Access Program for Maraviroc At Multiple Centers

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
maraviroc
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama
  • Health Services Center
  • El Rio, Special Immunology Associates
  • Health for Life Clinic PLLC
  • Thomas T Jefferson, MD
  • Vista Medical
  • AHF Research Center
  • Orange County Center for Special Immunology
  • Kaiser Permanente
  • Living Hope Clinical Trials
  • AltaMed Health Services Corporation
  • Kaiser Permanente Medical Center
  • Robert Bolan, MD
  • Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology
  • Peter J. Ruane, M.D. Inc.
  • Synergy Hematology-Oncology Associates
  • Cedars-Sinai Medical Center
  • Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.
  • Office of Anthony Mills, MD
  • Office of Dr. Salah Bibi, MD
  • Bonnie V Bock MD
  • Alta Bates Summit Medical Center
  • Desert Medical Group, Clinical Research Center
  • Riverside Medical Clinic
  • Fort Sutter Medical Complex
  • Sutter Institute for Medical Research
  • Sutter Medical Group
  • Quest Clinical Research
  • Kaiser Permanente Medical Center
  • Kaiser Permanente Santa Clara
  • Shared Medical Research Foundation
  • Tarzana Treatment Center
  • Bipin Bhagat MD Inc.
  • Kaiser Permanente Colorado
  • Kaiser Permanente of Colorado
  • Denver Infectious Disease Consultants, PLLC
  • Kaiser Permanente of Colorado
  • Connecticut Health Care Group
  • Infectious Disease Clinic
  • Dupont Circle Physicians Group
  • Internal Medicine Associates of Lee County
  • Infectious Disease Research Corp
  • Internal Medicine Associates of Lee County
  • Daniel Warner M.D., P.A. Consultive Medicine
  • Northpoint Medical, PA
  • Comprehensive Care Center
  • Office of Gary J. Richmond, MD
  • Internal Medicine Associates of Lee County
  • Therafirst Medical Centers
  • Sunshine Medical Institute
  • Osler Medical Inc.
  • Office of Albert Canas, MD
  • Steinhart Medical Associates
  • Care Resource
  • Donald Johnson, MD
  • Wohlfeiler, Piperato & Associates, LLC
  • Orlando Immunology Center
  • Infectious Diseases of Central Florida
  • Associates in Infectious Diseases
  • Barry Rodwick, MD
  • Infectious Diseases Associates
  • University Hepatitis Center at Bach & Godofsky, MD,PA
  • All Children's Hospital
  • Eric Nicholson, M.D., P.A.
  • University of South Florida
  • University of Sout Florida
  • Midtown Medical Center
  • Donald Watren MD
  • Philip Brachman MD
  • Family Health Care of Atlanta
  • Midtown West Medical
  • Absolute CARE
  • Kaiser Permanente
  • Atlanta VA Medical Center
  • Infectious Disease Specialists of Atlanta
  • Kaiser Permanente
  • Infectious Diseases Associates, PC
  • Chatham County Health Department
  • Infectious Disease Consultants
  • Ruth M. Rothstein CORE Center
  • Roger Trinh
  • Northstar Medical Center
  • Cotton-O'Neil Clinic
  • Kansas University Internal Medicine Midtown Clinic
  • Via Christi Research, Inc.
  • Chase Brexton Health Services Inc
  • Metro Health Care
  • Dr.'s Alpert, Trinh, and Posorske
  • Tufts - New England Medical Center
  • Fenway Community Health
  • Community Research Initiative of New England
  • Community Research Initiative of New England
  • The Office of Dr. Paul A. Benson, DO
  • Private Practice (Dr. Gregory Kuldanek)
  • St. John hospital and Medical Center
  • Private Practice
  • MSU Adult Medicine, 10
  • Hennepin County Medical Center
  • Nemechek Health Renewal
  • Private Practice (Dr. Mark Scheperle)
  • Partnership Health Center
  • CPMC Research Pharmacy
  • Leonia Medical Associates
  • Center for Infectious Diseaes
  • Hackensack University Medical Center
  • UMDNJ
  • University Hospital
  • Newark Community Health Center
  • South Jersey Infectious Disease
  • Premier Medical Research Group
  • Garden State Infectious Disease Associates, PA
  • Upstate Infectious Disease Associates
  • Allmed Medical and Rehabilitaion of NY
  • Bronx Lebanon Hospital Center
  • Woodhull Medical Center
  • New York Methodist Hospital
  • NYM Medical Pavilion
  • Chiu-Bin Hsiao, MD
  • The Office of Dr. Zale P. Bernstein, MD.
  • NYHQ
  • Schneider Children's Hospital
  • North Shore University Hospital, Department of Infectious Disease
  • Astor Medical Group, LLP
  • Beth Israel Medical Center
  • Paul Bellman, MD
  • Sidney Hillman Family Health Center
  • Ricky Hsu
  • Bellevue Hospital
  • NYU School of Medicine
  • Perion Smith
  • James I Jones Jr, MD
  • Sharon Lewin MD and Michael Rendel MD
  • Lenox Ave Clinic
  • Harlem Medical Associates
  • Mount Sinai Medical Center
  • Mount Sinai School of Medicine
  • New York-Presbyterian Hospital
  • Dr. Steven Fine
  • Jordon Glaser, MD
  • SUNY Upstate Medical University
  • ID Associates
  • Rosedale Infectious Diseases
  • Metro Health Systems
  • South Dayton Acute Care Consultants Inc.
  • University of Toledo - Health Science Campus
  • University of Oklahoma - Schusterman Clinic
  • The Research & Education Group
  • Kaiser Permanente-Northwest Region, Immune Deficiency Clinic
  • Lehigh Valley Hospital
  • Philadelphia FIGHT
  • RPS Infectious Diseases
  • The Miriam Hospital
  • Investigational Drug Services
  • Medical University of South Carolina
  • Medical University of South Carolina
  • Infectious Disease Associates of Memphis
  • The Office of Dr. Nicholaos C. Bellos, MD
  • The Office of Dr. Patrick W. Daly, MD.
  • The Office of Dr. Susan M. Diamond, MD.
  • La Fe CARE Center Clinic
  • Kelly, Allan Rowman MD
  • Tarrant County Infectious Disease Associates
  • Fernando Garcia, MD
  • Harris County Hospital District
  • Thomas Street Clinic
  • Diversified Medical Practices, PA
  • Baylor College of Medicine
  • The University of Texas Health Sciences Center at Houston
  • Brewton, Gary W MD
  • Research Access Network
  • The Office of Dr. Gordon E. Crofoot, MD.
  • DCOL Center for Clinical Research
  • Diagnostic Clinic of Longview, PA
  • Dr. James Bromley
  • Responsive ID Solutions
  • Clinical Alliance for Research & Education - Infectious Diseases
  • Infectious Diseases
  • Infectious Diseases Associates of Central Virginia
  • Infectious Disease Consultants
  • Hampton Roads Medical Specialists
  • Barbara Cassie
  • Crossover Ministry
  • William F. Ehni, MD
  • Emerald City Medical Arts
  • Group Health Cooperative
  • The Office of Dr. Daniel R. Coulston, MD
  • The Vancouver Clinic, Inc., P.S.
  • CAMC Memorial Hospital
  • Clinical Trials Center
  • University Physicians Internal Medicine
  • Fundacion Huesped, Departamento de Investigacion Clinica
  • FUNCEI
  • Holdsworth House Medical Practice
  • St. Vincent's Hospital
  • Albion Street Centre
  • Westmead Hospital
  • AIDS Medical Centre
  • Infectious Diseases Unit
  • Infectious Diseases Unit
  • Melbourne Sexual Health Centre
  • Clinical Research Unit, Infectious Diseases
  • Northside Clinic
  • Prahran Market Clinic
  • Allgemeines Krankenhaus Wien
  • Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1
  • Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung
  • Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde
  • Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses
  • Hôpital Erasme, Médecine Interne
  • Cliniques Universitaires Saint-Luc, Maladies Infectieuses
  • Centre Hospitalier Universitaire de Charleroi, Médecine Interne
  • Universitair Ziekenhuis Gent, Inwendige Geneeskunde
  • Academisch Ziekenhuis VUB
  • Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
  • CHU Sart-Tilman, Medecine Interne
  • Queen Elizabeth II Health Sciences Center
  • Hamilton Health Sciences - McMaster University Medical Centre
  • Sunnybrook Health Sciences Centre
  • Canadian Immunodeficiency Research Collaborative
  • Clinique médicale l'Actuel
  • Clinique Medicale du Quartier Latin
  • CHUM Hôtel-Dieu
  • Projet L.O.R.I.
  • Hospital Clínica Universidad Católica
  • Hospital Clínico San Borja Arriarán
  • Fundación para el Desarrollo de la Lucha contra el SIDA
  • Instituto Dominicano de Estudios Virologicos
  • Hopital Sainte Marguerite
  • Hopital Saint Antoine
  • Centre Hospitalier Universitaire de Caen
  • Hôpital Saint Jacques
  • Hopital Avicenne
  • Hôpital Saint-andré
  • Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne
  • Hopital Gabriel Montpied
  • CHU Michallon
  • Hopital La Source
  • Hopital de Bicêtre
  • Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie
  • Hôpital de la Croix Rousse
  • Hopital Gui de Chauliac
  • CHU de Nantes - Hopital Hotel Dieu
  • Hopital de l Archet 1
  • Hopital Saint-Louis
  • Centre Hospitalier Cochin Saint Vincent de Paul
  • Hôpital Necker-Service des Maladies Infectieuses et Tropicales
  • Hôpital de la Pitié Salpétrière
  • Hopital Europeen George Pompidou
  • Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses
  • Hopital Tenon, Service des Maladies Infectieuses
  • Chu Pontchaillou, Service des maladies infectieuses
  • Hôpital de Purpan
  • CHU de Tourcoing
  • Hopital Paul Brousse
  • Praxisgemeinschaft Bieniek & Cordes
  • Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
  • Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik
  • Gemeinschaftspraxis Dres. Rump und Usadel
  • Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin
  • Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,
  • Evagelismos Hospital
  • Greek Red Cross Hospital
  • General Hospital of Athens G. Gennimatas
  • Andreas Sygros Hospital
  • University Hospital of Patras
  • Regional General Hospital Tzaneio
  • AHEPA Hospital
  • Department of Medicine Queen Elizabeth Hospital
  • Department of Medicine, St. John's Medical College Hospital
  • Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre
  • YR Gaitonde Centre for AIDS Research and Education (YRG CARE)
  • Catherine McAuley Centre
  • St. James's Hospital
  • Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico
  • Unita' Operativa Malattie Infettive
  • Istituto di Malattie Infettive e Tropicali
  • Unita' Operativa di Malattie Infettive
  • Presidio Ospedaliero SS Annunziata
  • Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara
  • SOD Malattie Infettive, La Piastra dei Servizi
  • Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive
  • Fondazione Centro San Raffaele del Monte Tabor
  • Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive
  • Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia
  • Unita Operativa di Malattie Infettive e Tropicali
  • Fondazione IRCCS Policlinico S. Matteo
  • Reparto di Malattie Infettive, Azienda Sanitaria Locale
  • Policlinico Tor Vergata, Divisione Malattie Infettive
  • IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive
  • IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive
  • IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive
  • Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza
  • Universita'Cattolica del Sacro Cuore Policlinico Gemelli
  • Azienda Ospedaliera San Giovanni Addolorata
  • Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia
  • Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.
  • Unita' Operativa di Malattie Infettive
  • Physician Clinic
  • Hospital Sungai Buloh
  • Hospital Regional Lic. Adolfo Lopez Mateos
  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
  • Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran
  • Academisch Ziekenhuis Utrecht
  • Centro Hospitalar de Cascais
  • Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
  • Hospital Sta. Maria
  • Hospital São João
  • Centro Ararat Inc
  • HOPE Clinical Research
  • Institutul de Boli Infectioase "Prof. Matei Bals"
  • Spitalul de Boli Infectioase si Tropicale Victor Babes
  • Spitalul Clinic de Boli Infectioase Constanta
  • Spitalul Clinic de Boli Infectioase Sf. Parascheva
  • Hospital General Universitario de Elche
  • H. Universitari Germans Trias I Pujol
  • Hospital General de Granollers
  • Hospital Universitari de Bellvitge
  • Hospital de Basurto
  • Hospital Universitario Marques de Valdecilla
  • Hospital de Cabueñes
  • Hospital Clinico Universitario de Santiago de Compostela
  • Complejo Hospitalario Xeral-Cies
  • Hospital Donostia-Donostia Ospitalea
  • Hospital Universitario de Canarias
  • Hospital de Tortosa Verge de La Cinta
  • Hospital de Cruces
  • Hospital General Universitario de Alicante
  • Hospital Del Mar
  • Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau
  • Hospital Universitari Vall D'Hebron
  • Hospital Clinic I Provincial de Barcelona
  • Hospital Puerta Del Mar
  • Hospital Universitario Reina Sofia
  • Hospital Universitario San Cecilio
  • Hospital Universitario Virgen de Las Nieves
  • Hospital Universitario de La Princesa
  • Hospital General Gregorio Marañon
  • Hospital Carlos Iii
  • Hospital Ramon Y Cajal
  • Fundacion Jimenez Diaz
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz
  • Complejo Hospitalario Carlos Haya
  • Hospital Virgen de La Victoria
  • Hospital Costa Del Sol
  • Hospital Virgen Del Rocio
  • Complejo Hospitalario Nuestra Señora de Valme
  • Hospital Universitario Virgen de La Macarena
  • Hospital Universitario La Fe
  • Hospital Clinico Universitario
  • Consorcio Hospital General Universitario de Valencia
  • Hospital Arnau de Vilanova
  • Universitätsspital Zürich
  • Department of Infectious Disease, E-Da Hospital
  • Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre
  • North Manchester General Hospital
  • Regional Infectious Diseases Unit
  • Ian Charleson Centre
  • Department of Sexual Health
  • St Stephens Research Ltd
  • Imperial College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
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
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
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
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
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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)
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.

Full Information

First Posted
January 22, 2007
Last Updated
May 23, 2016
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00426660
Brief Title
Expanded Access Program for Maraviroc At Multiple Centers
Official Title
A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Non-Randomized
Enrollment
1047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
maraviroc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
Time Frame
Baseline up to Week 144
Title
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
Title
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
Description
Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
Description
Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
Description
Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
Description
Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.
Time Frame
Baseline up to Week 144
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
Description
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.
Time Frame
Baseline up to Week 144
Title
Change From Baseline in CD4 Cell Count
Description
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.
Time Frame
Baseline up to Week 144
Title
Change From Baseline in CD4 Cell Count Percent
Description
Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame
Baseline up to Week 144
Title
Change From Baseline in CD8 Cell Count
Description
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.
Time Frame
Baseline up to Week 144
Title
Change From Baseline in CD8 Cell Count Percent
Description
Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame
Baseline up to Week 144
Title
Median Time to Virologic Failure
Description
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.
Time Frame
Day 1 up to Week 144
Title
Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure
Description
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.
Time Frame
Baseline up to Week 144
Title
Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
Description
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.
Time Frame
Screening up to Week 144
Title
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
Description
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.
Time Frame
Baseline up to Week 144
Title
Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
Description
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.
Time Frame
Baseline up to Week 144

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001050&StudyName=Expanded%20Access%20Program%20for%20Maraviroc%20At%20Multiple%20Centers
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Expanded Access Program for Maraviroc At Multiple Centers

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