AzTrials
AzTrials

HIV InfectionsPhase 3NCT00426660

Expanded Access Program for Maraviroc At Multiple Centers

A Phase 3 study testing maraviroc in people with HIV Infections, run by ViiV Healthcare at 361 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
maraviroc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,047 participants
Where
361 sitesin 26 countries
Study dates
Feb 2007to Jun 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Trial locations and contacts

361 sites in 26 countries.

361 sites in 26 countries

United States190 sites

  • Upstate Infectious Disease Associates

    Albany, New York, 12208

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18102

  • Clinical Alliance for Research & Education - Infectious Diseases

    Annandale, Virginia, 22003

  • Infectious Diseases

    Arlington, Virginia, 22205-3633

  • Philip Brachman MD

    Atlanta, Georgia, 30309

  • Family Health Care of Atlanta

    Atlanta, Georgia, 30318-2513

  • Midtown West Medical

    Atlanta, Georgia, 30318

  • Absolute CARE

    Atlanta, Georgia, 30329

  • Kaiser Permanente

    Atlanta, Georgia, 30339

  • Chase Brexton Health Services Inc

    Baltimore, Maryland, 21201

  • The Office of Dr. Paul A. Benson, DO

    Berkley, Michigan, 48072

  • Vista Medical

    Beverly Hills, California, 90210-4212

  • AHF Research Center

    Beverly Hills, California, 90211

  • The University of Alabama

    Birmingham, Alabama, 35294-2050

  • Internal Medicine Associates of Lee County

    Bonita Springs, Florida, 34134

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Fenway Community Health

    Boston, Massachusetts, 02115

  • Community Research Initiative of New England

    Boston, Massachusetts, 02215-3318

  • Infectious Disease Research Corp

    Boynton Beach, Florida, 33426

  • Woodhull Medical Center

    Brooklyn, New York, 11206

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • NYM Medical Pavilion

    Brooklyn, New York, 11215

  • Chiu-Bin Hsiao, MD

    Buffalo, New York, 14215

  • The Office of Dr. Zale P. Bernstein, MD.

    Buffalo, New York, 14215

  • Internal Medicine Associates of Lee County

    Cape Coral, Florida, 33990

  • Investigational Drug Services

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • CAMC Memorial Hospital

    Charleston, West Virginia, 25304

  • Clinical Trials Center

    Charleston, West Virginia, 25304

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Roger Trinh

    Chicago, Illinois, 60613

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • Metro Health Systems

    Cleveland, Ohio, 44109

  • The Office of Dr. Nicholaos C. Bellos, MD

    Dallas, Texas, 75204

  • The Office of Dr. Patrick W. Daly, MD.

    Dallas, Texas, 75219

  • The Office of Dr. Susan M. Diamond, MD.

    Dallas, Texas, 75231

  • Infectious Diseases Associates of Central Virginia

    Danville, Virginia, 24541

  • South Dayton Acute Care Consultants Inc.

    Dayton, Ohio, 45429

  • Daniel Warner M.D., P.A. Consultive Medicine

    Daytona Beach, Florida, 32117

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Kaiser Permanente Colorado

    Denver, Colorado, 80205

  • Kaiser Permanente of Colorado

    Denver, Colorado, 80205

  • Denver Infectious Disease Consultants, PLLC

    Denver, Colorado, 80220

  • William F. Ehni, MD

    Edmonds, Washington, 98026

  • La Fe CARE Center Clinic

    El Paso, Texas, 79925

  • CPMC Research Pharmacy

    Englewood, New Jersey, 07631

  • Leonia Medical Associates

    Englewood, New Jersey, 07631

  • Infectious Disease Consultants

    Fairfax, Virginia, 22030

  • NYHQ

    Flushing, New York, 11367

  • Northpoint Medical, PA

    Fort Lauderdale, Florida, 33308

  • Therafirst Medical Centers

    Fort Lauderdale, Florida, 33308

  • Comprehensive Care Center

    Fort Lauderdale, Florida, 33311

  • Office of Gary J. Richmond, MD

    Fort Lauderdale, Florida, 33316

  • Internal Medicine Associates of Lee County

    Fort Myers, Florida, 33912

  • Kelly, Allan Rowman MD

    Fort Worth, Texas, 76104-3048

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Orange County Center for Special Immunology

    Fountain Valley, California, 92708

  • ID Associates

    Gastonia, North Carolina, 28054

  • Connecticut Health Care Group

    Glastonbury, Connecticut, 06033

  • Private Practice (Dr. Gregory Kuldanek)

    Grand Rapids, Michigan, 49546

  • Schneider Children's Hospital

    Great Neck, New York, 11042

  • Metro Health Care

    Greenbelt, Maryland, 20770-3525

  • St. John hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Center for Infectious Diseaes

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hampton Roads Medical Specialists

    Hampton, Virginia, 23666

  • Fernando Garcia, MD

    Harlingen, Texas, 78550

  • Kaiser Permanente

    Hayward, California, 94545

  • Health Services Center

    Hobson City, Alabama, 36201

  • Sunshine Medical Institute

    Hollywood, Florida, 33021

  • Harris County Hospital District

    Houston, Texas, 77009

  • Thomas Street Clinic

    Houston, Texas, 77009

  • Diversified Medical Practices, PA

    Houston, Texas, 77027

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The University of Texas Health Sciences Center at Houston

    Houston, Texas, 77030

  • Brewton, Gary W MD

    Houston, Texas, 77098-2807

  • Research Access Network

    Houston, Texas, 77098

  • The Office of Dr. Gordon E. Crofoot, MD.

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • University Physicians Internal Medicine

    Huntington, West Virginia, 25701

  • Kaiser Permanente

    Jonesboro, Georgia, 30236

  • Nemechek Health Renewal

    Kansas City, Missouri, 64111

  • Private Practice

    Keego Harbor, Michigan, 48320

  • Kaiser Permanente of Colorado

    Lafayette, Colorado, 80026

  • MSU Adult Medicine, 10

    Lansing, Michigan, 48910

  • Health for Life Clinic PLLC

    Little Rock, Arkansas, 72207

  • Thomas T Jefferson, MD

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Trials

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Diagnostic Clinic of Longview, PA

    Longview, Texas, 75605

  • AltaMed Health Services Corporation

    Los Angeles, California, 90022

  • Kaiser Permanente Medical Center

    Los Angeles, California, 90027

  • Robert Bolan, MD

    Los Angeles, California, 90028

  • Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology

    Los Angeles, California, 90033

  • Peter J. Ruane, M.D. Inc.

    Los Angeles, California, 90036

  • Synergy Hematology-Oncology Associates

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.

    Los Angeles, California, 90048

  • Office of Anthony Mills, MD

    Los Angeles, California, 90069

  • Barbara Cassie

    Lynchburg, Virginia, 24501

  • North Shore University Hospital, Department of Infectious Disease

    Manhasset, New York, 11030

  • Osler Medical Inc.

    Melbourne, Florida, 32901

  • Infectious Disease Associates of Memphis

    Memphis, Tennessee, 38119

  • Steinhart Medical Associates

    Miami, Florida, 33133

  • Care Resource

    Miami, Florida, 33137

  • Office of Albert Canas, MD

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Partnership Health Center

    Missoula, Montana, 59802

  • Office of Dr. Salah Bibi, MD

    Modesto, California, 95350

  • Astor Medical Group, LLP

    New York, New York, 10003

  • Beth Israel Medical Center

    New York, New York, 10003

  • Paul Bellman, MD

    New York, New York, 10003

  • Sidney Hillman Family Health Center

    New York, New York, 10003

  • Ricky Hsu

    New York, New York, 10011

  • Bellevue Hospital

    New York, New York, 10016

  • NYU School of Medicine

    New York, New York, 10016

  • Perion Smith

    New York, New York, 10018

  • James I Jones Jr, MD

    New York, New York, 10019-1819

  • Sharon Lewin MD and Michael Rendel MD

    New York, New York, 10024

  • Lenox Ave Clinic

    New York, New York, 10026

  • Harlem Medical Associates

    New York, New York, 10029

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • New York-Presbyterian Hospital

    New York, New York, 10032

  • UMDNJ

    Newark, New Jersey, 07103

  • University Hospital

    Newark, New Jersey, 07103

  • Newark Community Health Center

    Newark, New Jersey, 07114

  • Bonnie V Bock MD

    Newport Beach, California, 92663

  • Donald Johnson, MD

    North Miami Beach, Florida, 33162

  • Wohlfeiler, Piperato & Associates, LLC

    North Miami Beach, Florida, 33169

  • Infectious Disease Clinic

    Norwich, Connecticut, 06360

  • Alta Bates Summit Medical Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Infectious Diseases of Central Florida

    Orlando, Florida, 32806

  • Desert Medical Group, Clinical Research Center

    Palm Springs, California, 92262

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Associates in Infectious Diseases

    Port Saint Lucie, Florida, 34952

  • The Research & Education Group

    Portland, Oregon, 97210

  • Kaiser Permanente-Northwest Region, Immune Deficiency Clinic

    Portland, Oregon, 97227

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Crossover Ministry

    Richmond, Virginia, 23224

  • Infectious Diseases Associates, PC

    Riverdale, Georgia, 30274

  • Riverside Medical Clinic

    Riverside, California, 92506

  • Dr. Steven Fine

    Rochester, New York, 14605

  • Fort Sutter Medical Complex

    Sacramento, California, 95816

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • Sutter Medical Group

    Sacramento, California, 95816

  • Barry Rodwick, MD

    Safety Harbor, Florida, 34695

  • Dr. James Bromley

    San Antonio, Texas, 78212

  • Responsive ID Solutions

    San Antonio, Texas, 78258

  • Quest Clinical Research

    San Francisco, California, 94115-3029

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

  • Kaiser Permanente Santa Clara

    Santa Clara, California, 95051

  • Infectious Diseases Associates

    Sarasota, Florida, 34239

  • University Hepatitis Center at Bach & Godofsky, MD,PA

    Sarasota, Florida, 34243

  • Chatham County Health Department

    Savannah, Georgia, 31405

  • Emerald City Medical Arts

    Seattle, Washington, 98109

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Dr.'s Alpert, Trinh, and Posorske

    Silver Spring, Maryland, 20910

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • The Office of Dr. Daniel R. Coulston, MD

    Spokane, Washington, 99204

  • Community Research Initiative of New England

    Springfield, Massachusetts, 01107

  • Private Practice (Dr. Mark Scheperle)

    St Louis, Missouri, 63117

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Jordon Glaser, MD

    Stanton Island, New York, 10304

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Eric Nicholson, M.D., P.A.

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33606

  • University of Sout Florida

    Tampa, Florida, 33612

  • Midtown Medical Center

    Tampa, Florida, 33614

  • Shared Medical Research Foundation

    Tarzana, California, 91356

  • Tarzana Treatment Center

    Tarzana, California, 91356

  • Allmed Medical and Rehabilitaion of NY

    The Bronx, New York, 10454

  • Bronx Lebanon Hospital Center

    The Bronx, New York, 10457

  • University of Toledo - Health Science Campus

    Toledo, Ohio, 43614-5812

  • Premier Medical Research Group

    Toms River, New Jersey, 08755

  • Cotton-O'Neil Clinic

    Topeka, Kansas, 66606-1670

  • Infectious Disease Consultants

    Tucker, Georgia, 30084-8128

  • El Rio, Special Immunology Associates

    Tucson, Arizona, 85745

  • University of Oklahoma - Schusterman Clinic

    Tulsa, Oklahoma, 74135

  • The Vancouver Clinic, Inc., P.S.

    Vancouver, Washington, 98664

  • Bipin Bhagat MD Inc.

    Victorville, California, 92395

  • Garden State Infectious Disease Associates, PA

    Voorhees Township, New Jersey, 08043

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

  • Donald Watren MD

    West Palm Beach, Florida, 33401

  • RPS Infectious Diseases

    West Reading, Pennsylvania, 19611

  • Kansas University Internal Medicine Midtown Clinic

    Wichita, Kansas, 67214

  • Via Christi Research, Inc.

    Wichita, Kansas, 67214

Other trials in United States

Spain39 sites

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • H. Universitari Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital Del Mar

    Barcelona, Barcelona, 08003

  • Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Universitari Vall D'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital de Basurto

    Basurto, Bilbao, 48078

  • Hospital de Cabueñes

    Cabueñes, Gijon, 33394

  • Hospital Puerta Del Mar

    Cadiz, Cadiz, 11009

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14012

  • Hospital Donostia-Donostia Ospitalea

    Donostia / San Sebastian, San Sebastian, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202

  • Hospital Universitario San Cecilio

    Granada, Granada, 18012

  • Hospital Universitario Virgen de Las Nieves

    Granada, Granada, 18014

  • Hospital General de Granollers

    Granollers, Barcelona, 08400

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

  • Hospital General Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital Carlos Iii

    Madrid, Madrid, 28029

  • Hospital Ramon Y Cajal

    Madrid, Madrid, 28034

  • Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Complejo Hospitalario Carlos Haya

    Málaga, Malaga, 29010

  • Hospital Virgen de La Victoria

    Málaga, Malaga, 29010

  • Hospital Costa Del Sol

    Málaga, Malaga, 29600

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, La Coruña, 15706

  • Hospital Virgen Del Rocio

    Seville, Sevilla, 41013

  • Complejo Hospitalario Nuestra Señora de Valme

    Seville, Sevilla, 41014

  • Hospital Universitario Virgen de La Macarena

    Seville, Sevilla, 41071

  • Hospital de Tortosa Verge de La Cinta

    Tortosa, Tarragona, 43500

  • Hospital Universitario La Fe

    Valencia, Valencia, 46009

  • Hospital Clinico Universitario

    Valencia, Valencia, 46010

  • Consorcio Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

  • Hospital Arnau de Vilanova

    Valencia, Valencia, 46015

  • Complejo Hospitalario Xeral-Cies

    Vigo, Pontevedra, 36204

Other trials in Spain

France27 sites

  • Hôpital Saint Jacques

    Besançon, France, 25030

  • Hopital Avicenne

    Bobigny, 93009

  • Hôpital Saint-andré

    Bordeaux, 33075

  • Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne

    Bordeaux, 33076

  • Centre Hospitalier Universitaire de Caen

    Caen, Cedex, 14033

  • Hopital Gabriel Montpied

    Clermont-Ferrand, France, 63000

  • CHU Michallon

    Grenoble, France, 38043

  • Hopital La Source

    La Source, 45100

  • Hopital de Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Hôpital de la Croix Rousse

    Lyon, 690317

  • Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie

    Lyon, 69288

  • Hopital Sainte Marguerite

    Marseille, Cedex 09, 13274

  • Hopital Gui de Chauliac

    Montpellier, 34295

  • CHU de Nantes - Hopital Hotel Dieu

    Nantes, 44093

  • Hopital de l Archet 1

    Nice Cedex 3, 06, 06202

  • Hopital Saint Antoine

    Paris, Cedex 12, 75571

  • Centre Hospitalier Cochin Saint Vincent de Paul

    Paris, France, 75679

  • Hôpital de la Pitié Salpétrière

    Paris, 75013

  • Hopital Europeen George Pompidou

    Paris, 75015

  • Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses

    Paris, 75018

  • Hopital Tenon, Service des Maladies Infectieuses

    Paris, 75020

  • Hopital Saint-Louis

    Paris, 75475

  • Hôpital Necker-Service des Maladies Infectieuses et Tropicales

    Paris, 75743

  • Chu Pontchaillou, Service des maladies infectieuses

    Rennes, France, 35033

  • Hôpital de Purpan

    Toulouse, France, 31059

  • CHU de Tourcoing

    Tourcoing, 59208

  • Hopital Paul Brousse

    Villejuif, 94800

Other trials in France

Italy24 sites

  • Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico

    Bari, 70124

  • Unita' Operativa Malattie Infettive

    Bologna, 40138

  • Istituto di Malattie Infettive e Tropicali

    Brescia, 25123

  • Unita' Operativa di Malattie Infettive

    Catania, 95126

  • Presidio Ospedaliero SS Annunziata

    Chieti Scalo, 66100

  • Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara

    Ferrara, 44100

  • SOD Malattie Infettive, La Piastra dei Servizi

    Florence, 50100

  • Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive

    Genova, 16132

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive

    Milan, 20157

  • Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia

    Modena, 41100

  • Unita Operativa di Malattie Infettive e Tropicali

    Padova, 35128

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Reparto di Malattie Infettive, Azienda Sanitaria Locale

    Pescara, 65124

  • Policlinico Tor Vergata, Divisione Malattie Infettive

    Roma, 00133

  • IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive

    Roma, 00149

  • IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive

    Roma, 00149

  • IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive

    Roma, 00149

  • Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza

    Roma, 00161

  • Universita'Cattolica del Sacro Cuore Policlinico Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00184

  • Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia

    Torino, 10149

  • Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.

    Torrette Di Ancona, 60121

  • Unita' Operativa di Malattie Infettive

    Venezia, 30122

Other trials in Italy

Australia11 sites

  • Infectious Diseases Unit

    Adelaide, South Australia, 5000

  • AIDS Medical Centre

    Brisbane, Queensland, 4000

  • Melbourne Sexual Health Centre

    Carlton, Victoria, 3053

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Northside Clinic

    Fitzroy North, Victoria, 3068

  • Infectious Diseases Unit

    Herston, Queensland, 4029

  • Clinical Research Unit, Infectious Diseases

    Melbourne, Victoria, 3004

  • Prahran Market Clinic

    South Yarra, Victoria, 3141

  • Albion Street Centre

    Surry Hills, New South Wales, 2010

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Belgium9 sites

  • Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde

    Antwerp, 2000

  • Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses

    Brussels, 1000

  • Hôpital Erasme, Médecine Interne

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc, Maladies Infectieuses

    Brussels, 1200

  • Centre Hospitalier Universitaire de Charleroi, Médecine Interne

    Charleroi, 6000

  • Universitair Ziekenhuis Gent, Inwendige Geneeskunde

    Ghent, 9000

  • Academisch Ziekenhuis VUB

    Jette, B-1090

  • Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

    Leuven, 3000

  • CHU Sart-Tilman, Medecine Interne

    Liège, 4000

Other trials in Belgium

Canada8 sites

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton Health Sciences - McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • Clinique médicale l'Actuel

    Montreal, Quebec, H2L 4P9

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • CHUM Hôtel-Dieu

    Montreal, Quebec, H2W 1T8

  • Projet L.O.R.I.

    Montreal, Quebec, H3H 1V1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Canadian Immunodeficiency Research Collaborative

    Toronto, Ontario, M5B 1L6

Other trials in Canada

Greece7 sites

  • Evagelismos Hospital

    Athens, Attica, 10676

  • Greek Red Cross Hospital

    Athens, Attica, 115 26

  • General Hospital of Athens G. Gennimatas

    Athens, 115 27

  • Andreas Sygros Hospital

    Athens, 161 21

  • University Hospital of Patras

    Pátrai, 265 00

  • Regional General Hospital Tzaneio

    Piraeus, 185 36

  • AHEPA Hospital

    Thessaloniki, 54636

Other trials in Greece

United Kingdom7 sites

  • Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre

    Brighton, Sussex, BN2 1ES

  • North Manchester General Hospital

    Crumpsall, Manchester, M8 6RB

  • Regional Infectious Diseases Unit

    Edinburgh, EH4 2XU

  • Ian Charleson Centre

    London, NW3 2QG

  • Department of Sexual Health

    London, SE5 9RS

  • St Stephens Research Ltd

    London, SW10 9NH

  • Imperial College

    London, W2 1NY

Other trials in United Kingdom

Germany6 sites

  • Praxisgemeinschaft Bieniek & Cordes

    Berlin, 10243

  • Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,

    Cologne, 50937

  • Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

    Dresden, 01307

  • Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik

    Essen, 45122

  • Gemeinschaftspraxis Dres. Rump und Usadel

    Freiburg im Breisgau, 79098

  • Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin

    Hanover, 30625

Other trials in Germany

Portugal4 sites

  • Centro Hospitalar de Cascais

    Cascais, 2750-349

  • Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

    Lisbon, 1169-050

  • Hospital Sta. Maria

    Lisbon, 1649-035

  • Hospital São João

    Porto, 4200-319

Other trials in Portugal

Romania4 sites

  • Institutul de Boli Infectioase "Prof. Matei Bals"

    Bucharest, Sector 2, 021105

  • Spitalul de Boli Infectioase si Tropicale Victor Babes

    Bucharest, 030303

  • Spitalul Clinic de Boli Infectioase Constanta

    Constanța, Constanța County, 900709

  • Spitalul Clinic de Boli Infectioase Sf. Parascheva

    Iași, Iaşi, 700116

Other trials in Romania

Austria3 sites

  • Allgemeines Krankenhaus Wien

    A-1090

  • Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1

    Graz, A-8020

  • Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung

    Vienna, A-1140

Other trials in Austria

India3 sites

  • Department of Medicine, St. John's Medical College Hospital

    Bangalore, Karnataka, 560 034

  • YR Gaitonde Centre for AIDS Research and Education (YRG CARE)

    Chennai, Tamil Nadu, 600 113

  • Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre

    Mumbai, Maharashtra, 400 026

Other trials in India

Mexico3 sites

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 44280

  • Hospital Regional Lic. Adolfo Lopez Mateos

    Mexico City, Mexico City, 01030

  • Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran

    Tlalpan, Mexico Df, CP 14000

Other trials in Mexico

Argentina2 sites

  • Fundacion Huesped, Departamento de Investigacion Clinica

    Buenos Aires, C1202ABB

  • FUNCEI

    Buenos Aires, C1425AWK

Other trials in Argentina

Chile2 sites

  • Hospital Clínica Universidad Católica

    Santiago, RM, 8330023

  • Hospital Clínico San Borja Arriarán

    Santiago, RM, 8360160

Other trials in Chile

Ireland2 sites

  • Catherine McAuley Centre

    Dublin, 7

  • St. James's Hospital

    Dublin, 8

Other trials in Ireland

Malaysia2 sites

  • Physician Clinic

    Kota Bharu, Kelantan, 15586

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Puerto Rico2 sites

  • Centro Ararat Inc

    Ponce, PR, 00717-1563

  • HOPE Clinical Research

    San Juan, 00909

Other trials in Puerto Rico

Costa Rica1 site

  • Fundación para el Desarrollo de la Lucha contra el SIDA

    Barrio Aranjuez, Provincia de San José

Other trials in Costa Rica

Dominican Republic1 site

  • Instituto Dominicano de Estudios Virologicos

    Santo Domingo

Other trials in Dominican Republic

Hong Kong1 site

  • Department of Medicine Queen Elizabeth Hospital

    Kowloon

Other trials in Hong Kong

Netherlands1 site

  • Academisch Ziekenhuis Utrecht

    Utrecht, NL 3584 CX

Other trials in Netherlands

Switzerland1 site

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Taiwan1 site

  • Department of Infectious Disease, E-Da Hospital

    Kaohsiung County, 824

Other trials in Taiwan

About this study

Official title: A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

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.

Conditions
HIV Infections
Being tested
maraviroc
Keywords
HIV Infections
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • maravirocDrug

    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.

Study groups in NCT00426660
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: maraviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to Week 144

  2. 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.

    Measured: Baseline up to Week 144

  3. 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.

    Measured: Baseline up to Week 144

  4. 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.

    Measured: Baseline up to Week 144

  5. Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load

    Measured: Baseline up to Week 144

  6. Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts

    Measured: Baseline up to Week 144

  7. Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy

    Measured: Baseline up to Week 144

  8. 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.

    Measured: Baseline up to Week 144

  9. 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.

    Measured: Baseline up to Week 144

  10. 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.

    Measured: Baseline up to Week 144

  11. 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.

    Measured: Baseline up to Week 144

Secondary outcomes (13)

  1. 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.

    Measured: Baseline up to Week 144

  2. 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.

    Measured: Baseline up to Week 144

  3. 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.

    Measured: Baseline up to Week 144

  4. 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.

    Measured: Baseline up to Week 144

  5. 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.

    Measured: Baseline up to Week 144

  6. 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.

    Measured: Baseline up to Week 144

  7. 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.

    Measured: Baseline up to Week 144

  8. 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.

    Measured: Baseline up to Week 144

  9. 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.

    Measured: Day 1 up to Week 144

  10. 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.

    Measured: Baseline up to Week 144

  11. 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.

    Measured: Screening up to Week 144

  12. 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.

    Measured: Baseline up to Week 144

  13. 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.

    Measured: Baseline up to Week 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Enrolment
1,047 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00426660
Sponsor's protocol ID
A4001050
Other IDs
2006-004306-50, EAP
Status last verified
May 2016
First submitted
22 Jan 2007
Last updated
29 Jun 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing maraviroc in people with HIV Infections, run by ViiV Healthcare at 361 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 361 sites in United States, Spain, France, Italy, Australia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) (time frame: Baseline up to Week 144). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00426660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.

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