Clinical trial NCT00426660: Expanded Access Program for Maraviroc At Multiple Centers
Official title: A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV Infections
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 1047
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
timeFrame: Baseline up to Week 144
Secondary outcomes:
measure: Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
timeFrame: Baseline up to Week 144
measure: Change From Baseline in CD4 Cell Count
timeFrame: Baseline up to Week 144
measure: Change From Baseline in CD4 Cell Count Percent
timeFrame: Baseline up to Week 144
measure: Change From Baseline in CD8 Cell Count
timeFrame: Baseline up to Week 144
measure: Change From Baseline in CD8 Cell Count Percent
timeFrame: Baseline up to Week 144
measure: Median Time to Virologic Failure
timeFrame: Day 1 up to Week 144
measure: Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure
timeFrame: Baseline up to Week 144
measure: Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
timeFrame: Screening up to Week 144
measure: 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
timeFrame: Baseline up to Week 144
measure: Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
timeFrame: Baseline up to Week 144
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama
state: Alabama
city: Hobson City
country: United States
facility: Health Services Center
state: Alabama
city: Tucson
country: United States
facility: El Rio, Special Immunology Associates
state: Arizona
city: Little Rock
country: United States
facility: Health for Life Clinic PLLC
state: Arkansas
city: Little Rock
country: United States
facility: Thomas T Jefferson, MD
state: Arkansas
city: Beverly Hills
country: United States
facility: Vista Medical
state: California
city: Beverly Hills
country: United States
facility: AHF Research Center
state: California
city: Fountain Valley
country: United States
facility: Orange County Center for Special Immunology
state: California
city: Hayward
country: United States
facility: Kaiser Permanente
state: California
city: Long Beach
country: United States
facility: Living Hope Clinical Trials
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: Robert Bolan, MD
state: California
city: Los Angeles
country: United States
facility: Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, M.D. Inc.
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology-Oncology Associates
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.
state: California
city: Los Angeles
country: United States
facility: Office of Anthony Mills, MD
state: California
city: Modesto
country: United States
facility: Office of Dr. Salah Bibi, MD
state: California
city: Newport Beach
country: United States
facility: Bonnie V Bock MD
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group, Clinical Research Center
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic
state: California
city: Sacramento
country: United States
facility: Fort Sutter Medical Complex
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Tarzana
country: United States
facility: Shared Medical Research Foundation
state: California
city: Tarzana
country: United States
facility: Tarzana Treatment Center
state: California
city: Victorville
country: United States
facility: Bipin Bhagat MD Inc.
state: California
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Infectious Disease Consultants, PLLC
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: Glastonbury
country: United States
facility: Connecticut Health Care Group
state: Connecticut
city: Norwich
country: United States
facility: Infectious Disease Clinic
state: Connecticut
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Bonita Springs
country: United States
facility: Internal Medicine Associates of Lee County
state: Florida
city: Boynton Beach
country: United States
facility: Infectious Disease Research Corp
state: Florida
city: Cape Coral
country: United States
facility: Internal Medicine Associates of Lee County
state: Florida
city: Daytona Beach
country: United States
facility: Daniel Warner M.D., P.A. Consultive Medicine
state: Florida
city: Fort Lauderdale
country: United States
facility: Northpoint Medical, PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Comprehensive Care Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Office of Gary J. Richmond, MD
state: Florida
city: Fort Myers
country: United States
facility: Internal Medicine Associates of Lee County
state: Florida
city: Ft. Lauderdale
country: United States
facility: Therafirst Medical Centers
state: Florida
city: Hollywood
country: United States
facility: Sunshine Medical Institute
state: Florida
city: Melbourne
country: United States
facility: Osler Medical Inc.
state: Florida
city: Miami Beach
country: United States
facility: Office of Albert Canas, MD
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Miami
country: United States
facility: Care Resource
state: Florida
city: North Miami Beach
country: United States
facility: Donald Johnson, MD
state: Florida
city: North Miami Beach
country: United States
facility: Wohlfeiler, Piperato & Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Infectious Diseases of Central Florida
state: Florida
city: Port St. Lucie
country: United States
facility: Associates in Infectious Diseases
state: Florida
city: Safety Harbor
country: United States
facility: Barry Rodwick, MD
state: Florida
city: Sarasota
country: United States
facility: Infectious Diseases Associates
state: Florida
city: Sarasota
country: United States
facility: University Hepatitis Center at Bach & Godofsky, MD,PA
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tallahassee
country: United States
facility: Eric Nicholson, M.D., P.A.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: University of Sout Florida
state: Florida
city: Tampa
country: United States
facility: Midtown Medical Center
state: Florida
city: West Palm Beach
country: United States
facility: Donald Watren MD
state: Florida
city: Atlanta
country: United States
facility: Philip Brachman MD
state: Georgia
city: Atlanta
country: United States
facility: Family Health Care of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Midtown West Medical
state: Georgia
city: Atlanta
country: United States
facility: Absolute CARE
state: Georgia
city: Atlanta
country: United States
facility: Kaiser Permanente
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Jonesboro
country: United States
facility: Kaiser Permanente
state: Georgia
city: Riverdale
country: United States
facility: Infectious Diseases Associates, PC
state: Georgia
city: Savannah
country: United States
facility: Chatham County Health Department
state: Georgia
city: Tucker
country: United States
facility: Infectious Disease Consultants
state: Georgia
city: Chicago
country: United States
facility: Ruth M. Rothstein CORE Center
state: Illinois
city: Chicago
country: United States
facility: Roger Trinh
state: Illinois
city: Chicago
country: United States
facility: Northstar Medical Center
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Kansas University Internal Medicine Midtown Clinic
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research, Inc.
state: Kansas
city: Baltimore
country: United States
facility: Chase Brexton Health Services Inc
state: Maryland
city: Greenbelt
country: United States
facility: Metro Health Care
state: Maryland
city: Silver Spring
country: United States
facility: Dr.'s Alpert, Trinh, and Posorske
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Springfield
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Berkley
country: United States
facility: The Office of Dr. Paul A. Benson, DO
state: Michigan
city: Grand Rapids
country: United States
facility: Private Practice (Dr. Gregory Kuldanek)
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: St. John hospital and Medical Center
state: Michigan
city: Keego Harbor
country: United States
facility: Private Practice
state: Michigan
city: Lansing
country: United States
facility: MSU Adult Medicine, 10
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Nemechek Health Renewal
state: Missouri
city: St. Louis
country: United States
facility: Private Practice (Dr. Mark Scheperle)
state: Missouri
city: Missoula
country: United States
facility: Partnership Health Center
state: Montana
city: Englewood
country: United States
facility: CPMC Research Pharmacy
state: New Jersey
city: Englewood
country: United States
facility: Leonia Medical Associates
state: New Jersey
city: Hackensack
country: United States
facility: Center for Infectious Diseaes
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Newark
country: United States
facility: Newark Community Health Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Toms River
country: United States
facility: Premier Medical Research Group
state: New Jersey
city: Voorhees
country: United States
facility: Garden State Infectious Disease Associates, PA
state: New Jersey
city: Albany
country: United States
facility: Upstate Infectious Disease Associates
state: New York
city: Bronx
country: United States
facility: Allmed Medical and Rehabilitaion of NY
state: New York
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Brooklyn
country: United States
facility: Woodhull Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Brooklyn
country: United States
facility: NYM Medical Pavilion
state: New York
city: Buffalo
country: United States
facility: Chiu-Bin Hsiao, MD
state: New York
city: Buffalo
country: United States
facility: The Office of Dr. Zale P. Bernstein, MD.
state: New York
city: Flushing
country: United States
facility: NYHQ
state: New York
city: Great Neck
country: United States
facility: Schneider Children's Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital, Department of Infectious Disease
state: New York
city: New York
country: United States
facility: Astor Medical Group, LLP
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Paul Bellman, MD
state: New York
city: New York
country: United States
facility: Sidney Hillman Family Health Center
state: New York
city: New York
country: United States
facility: Ricky Hsu
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Perion Smith
state: New York
city: New York
country: United States
facility: James I Jones Jr, MD
state: New York
city: New York
country: United States
facility: Sharon Lewin MD and Michael Rendel MD
state: New York
city: New York
country: United States
facility: Lenox Ave Clinic
state: New York
city: New York
country: United States
facility: Harlem Medical Associates
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: Dr. Steven Fine
state: New York
city: Stanton Island
country: United States
facility: Jordon Glaser, MD
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Gastonia
country: United States
facility: ID Associates
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Infectious Diseases
state: North Carolina
city: Cleveland
country: United States
facility: Metro Health Systems
state: Ohio
city: Dayton
country: United States
facility: South Dayton Acute Care Consultants Inc.
state: Ohio
city: Toledo
country: United States
facility: University of Toledo - Health Science Campus
state: Ohio
city: Tulsa
country: United States
facility: University of Oklahoma - Schusterman Clinic
state: Oklahoma
city: Portland
country: United States
facility: The Research & Education Group
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente-Northwest Region, Immune Deficiency Clinic
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: West Reading
country: United States
facility: RPS Infectious Diseases
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Investigational Drug Services
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Infectious Disease Associates of Memphis
state: Tennessee
city: Dallas
country: United States
facility: The Office of Dr. Nicholaos C. Bellos, MD
state: Texas
city: Dallas
country: United States
facility: The Office of Dr. Patrick W. Daly, MD.
state: Texas
city: Dallas
country: United States
facility: The Office of Dr. Susan M. Diamond, MD.
state: Texas
city: El Paso
country: United States
facility: La Fe CARE Center Clinic
state: Texas
city: Fort Worth
country: United States
facility: Kelly, Allan Rowman MD
state: Texas
city: Ft. Worth
country: United States
facility: Tarrant County Infectious Disease Associates
state: Texas
city: Harlingen
country: United States
facility: Fernando Garcia, MD
state: Texas
city: Houston
country: United States
facility: Harris County Hospital District
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: Houston
country: United States
facility: Diversified Medical Practices, PA
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Sciences Center at Houston
state: Texas
city: Houston
country: United States
facility: Brewton, Gary W MD
state: Texas
city: Houston
country: United States
facility: Research Access Network
state: Texas
city: Houston
country: United States
facility: The Office of Dr. Gordon E. Crofoot, MD.
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview, PA
state: Texas
city: San Antonio
country: United States
facility: Dr. James Bromley
state: Texas
city: San Antonio
country: United States
facility: Responsive ID Solutions
state: Texas
city: Annandale
country: United States
facility: Clinical Alliance for Research & Education - Infectious Diseases
state: Virginia
city: Arlington
country: United States
facility: Infectious Diseases
state: Virginia
city: Danville
country: United States
facility: Infectious Diseases Associates of Central Virginia
state: Virginia
city: Fairfax
country: United States
facility: Infectious Disease Consultants
state: Virginia
city: Hampton
country: United States
facility: Hampton Roads Medical Specialists
state: Virginia
city: Lynchburg
country: United States
facility: Barbara Cassie
state: Virginia
city: Richmond
country: United States
facility: Crossover Ministry
state: Virginia
city: Edmonds
country: United States
facility: William F. Ehni, MD
state: Washington
city: Seattle
country: United States
facility: Emerald City Medical Arts
state: Washington
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
city: Spokane
country: United States
facility: The Office of Dr. Daniel R. Coulston, MD
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic, Inc., P.S.
state: Washington
city: Charleston
country: United States
facility: CAMC Memorial Hospital
state: West Virginia
city: Charleston
country: United States
facility: Clinical Trials Center
state: West Virginia
city: Huntington
country: United States
facility: University Physicians Internal Medicine
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped, Departamento de Investigacion Clinica
city: Buenos Aires
country: Argentina
facility: FUNCEI
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Surry Hills
country: Australia
facility: Albion Street Centre
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: AIDS Medical Centre
state: Queensland
city: Herston
country: Australia
facility: Infectious Diseases Unit
state: Queensland
city: Adelaide
country: Australia
facility: Infectious Diseases Unit
state: South Australia
city: Carlton
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
city: Melbourne
country: Australia
facility: Clinical Research Unit, Infectious Diseases
state: Victoria
city: North Fitzroy
country: Australia
facility: Northside Clinic
state: Victoria
city: South Yarra
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: A-1090
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Graz
country: Austria
facility: Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1
city: Wien
country: Austria
facility: Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung
city: Antwerpen
country: Belgium
facility: Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde
city: Bruxelles
country: Belgium
facility: Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses
city: Bruxelles
country: Belgium
facility: Hôpital Erasme, Médecine Interne
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Maladies Infectieuses
city: Charleroi
country: Belgium
facility: Centre Hospitalier Universitaire de Charleroi, Médecine Interne
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent, Inwendige Geneeskunde
city: Jette
country: Belgium
facility: Academisch Ziekenhuis VUB
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde
city: Liège
country: Belgium
facility: CHU Sart-Tilman, Medecine Interne
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Canadian Immunodeficiency Research Collaborative
state: Ontario
city: Montreal
country: Canada
facility: Clinique médicale l'Actuel
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: CHUM Hôtel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: Projet L.O.R.I.
state: Quebec
city: Santiago
country: Chile
facility: Hospital Clínica Universidad Católica
state: RM
city: Santiago
country: Chile
facility: Hospital Clínico San Borja Arriarán
state: RM
city: Barrio Aranjuez
country: Costa Rica
facility: Fundación para el Desarrollo de la Lucha contra el SIDA
state: San Jose
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virologicos
city: Marseille
country: France
facility: Hopital Sainte Marguerite
state: Cedex 09
city: Paris
country: France
facility: Hopital Saint Antoine
state: Cedex 12
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
state: Cedex
city: Besancon
country: France
facility: Hôpital Saint Jacques
city: Bobigny Cedex
country: France
facility: Hopital Avicenne
city: Bordeaux Cedex
country: France
facility: Hôpital Saint-andré
city: Bordeaux
country: France
facility: Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne
city: Clermont Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Grenoble Cedex 09
country: France
facility: CHU Michallon
city: La Source
country: France
facility: Hopital La Source
city: Le Kremlin Bicêtre
country: France
facility: Hopital de Bicêtre
city: Lyon Cedex 02
country: France
facility: Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie
city: Lyon Cedex 04
country: France
facility: Hôpital de la Croix Rousse
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nantes
country: France
facility: CHU de Nantes - Hopital Hotel Dieu
city: Nice Cedex 3, 06
country: France
facility: Hopital de l Archet 1
city: Paris Cedex 10
country: France
facility: Hopital Saint-Louis
city: Paris CEDEX 14
country: France
facility: Centre Hospitalier Cochin Saint Vincent de Paul
city: Paris cedex 15
country: France
facility: Hôpital Necker-Service des Maladies Infectieuses et Tropicales
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Paris
country: France
facility: Hopital Europeen George Pompidou
city: Paris
country: France
facility: Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses
city: Paris
country: France
facility: Hopital Tenon, Service des Maladies Infectieuses
city: Rennes
country: France
facility: Chu Pontchaillou, Service des maladies infectieuses
city: Toulouse
country: France
facility: Hôpital de Purpan
city: Tourcoing
country: France
facility: CHU de Tourcoing
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Berlin
country: Germany
facility: Praxisgemeinschaft Bieniek & Cordes
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie
city: Essen
country: Germany
facility: Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik
city: Freiburg
country: Germany
facility: Gemeinschaftspraxis Dres. Rump und Usadel
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,
city: Athens
country: Greece
facility: Evagelismos Hospital
state: Attiki
city: Athens
country: Greece
facility: Greek Red Cross Hospital
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens G. Gennimatas
city: Athens
country: Greece
facility: Andreas Sygros Hospital
city: Patras
country: Greece
facility: University Hospital of Patras
city: Piraeus
country: Greece
facility: Regional General Hospital Tzaneio
city: Thessaloniki
country: Greece
facility: AHEPA Hospital
city: Kowloon
country: Hong Kong
facility: Department of Medicine Queen Elizabeth Hospital
city: Bangalore
country: India
facility: Department of Medicine, St. John's Medical College Hospital
state: Karnataka
city: Mumbai
country: India
facility: Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre
state: Maharashtra
city: Chennai
country: India
facility: YR Gaitonde Centre for AIDS Research and Education (YRG CARE)
state: Tamil Nadu
city: Dublin
country: Ireland
facility: Catherine McAuley Centre
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Bari
country: Italy
facility: Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico
city: Bologna
country: Italy
facility: Unita' Operativa Malattie Infettive
city: Brescia
country: Italy
facility: Istituto di Malattie Infettive e Tropicali
city: Catania
country: Italy
facility: Unita' Operativa di Malattie Infettive
city: Chieti Scalo
country: Italy
facility: Presidio Ospedaliero SS Annunziata
city: Ferrara
country: Italy
facility: Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara
city: Firenze
country: Italy
facility: SOD Malattie Infettive, La Piastra dei Servizi
city: Genova
country: Italy
facility: Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Milano
country: Italy
facility: Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive
city: Modena
country: Italy
facility: Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia
city: Padova
country: Italy
facility: Unita Operativa di Malattie Infettive e Tropicali
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Pescara
country: Italy
facility: Reparto di Malattie Infettive, Azienda Sanitaria Locale
city: Roma
country: Italy
facility: Policlinico Tor Vergata, Divisione Malattie Infettive
city: Roma
country: Italy
facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive
city: Roma
country: Italy
facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive
city: Roma
country: Italy
facility: IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive
city: Roma
country: Italy
facility: Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza
city: Roma
country: Italy
facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
city: Torino
country: Italy
facility: Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia
city: Torrette di Ancona
country: Italy
facility: Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.
city: Venezia
country: Italy
facility: Unita' Operativa di Malattie Infettive
city: Kota Bharu
country: Malaysia
facility: Physician Clinic
state: Kelantan
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
state: Selangor
city: Mexico
country: Mexico
facility: Hospital Regional Lic. Adolfo Lopez Mateos
state: DF
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
state: Jalisco
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran
state: Mexico Df
city: Utrecht
country: Netherlands
facility: Academisch Ziekenhuis Utrecht
city: Cascais
country: Portugal
facility: Centro Hospitalar de Cascais
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
city: Lisbon
country: Portugal
facility: Hospital Sta. Maria
city: Porto
country: Portugal
facility: Hospital São João
city: Ponce
country: Puerto Rico
facility: Centro Ararat Inc
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research
city: Bucuresti
country: Romania
facility: Institutul de Boli Infectioase "Prof. Matei Bals"
state: Sector 2
city: Bucharest
country: Romania
facility: Spitalul de Boli Infectioase si Tropicale Victor Babes
city: Constanta
country: Romania
facility: Spitalul Clinic de Boli Infectioase Constanta
city: Iasi
country: Romania
facility: Spitalul Clinic de Boli Infectioase Sf. Parascheva
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Badalona
country: Spain
facility: H. Universitari Germans Trias I Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Bilbao
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Cabueñes
country: Spain
facility: Hospital de Cabueñes
state: Gijon
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: La Coruña
city: Vigo
country: Spain
facility: Complejo Hospitalario Xeral-Cies
state: Pontevedra
city: Donostia
country: Spain
facility: Hospital Donostia-Donostia Ospitalea
state: San Sebastian
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Tortosa
country: Spain
facility: Hospital de Tortosa Verge de La Cinta
state: Tarragona
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Cadiz
country: Spain
facility: Hospital Puerta Del Mar
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Carlos Iii
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Complejo Hospitalario Carlos Haya
city: Malaga
country: Spain
facility: Hospital Virgen de La Victoria
city: Malaga
country: Spain
facility: Hospital Costa Del Sol
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Sevilla
country: Spain
facility: Complejo Hospitalario Nuestra Señora de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de La Macarena
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kaohsiung County
country: Taiwan
facility: Department of Infectious Disease, E-Da Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre
state: Sussex
city: Crumpsall, Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Edinburgh
country: United Kingdom
facility: Regional Infectious Diseases Unit
city: London
country: United Kingdom
facility: Ian Charleson Centre
city: London
country: United Kingdom
facility: Department of Sexual Health
city: London
country: United Kingdom
facility: St Stephens Research Ltd
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: