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Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With Ccr5 Tropic HIV 1

Information source: ViiV Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1

Intervention: Maraviroc (Drug); Emtricitabine/tenofovir (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: ViiV Healthcare

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Clinical Details

Official title: A Multicenter, Randomized, Double Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir +Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naïve HIV Infected Patients With Ccr5 Tropic HIV 1

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of subjects with plasma HIV 1 RNA <50 copies/mL at Week 48.

Secondary outcome:

Safety: Frequency, severity and relationship of adverse events to test drug; serious adverse events; discontinuations due to adverse events; and frequency and severity of abnormal laboratory values.

The relationship between the proportion of patients with plasma HIV 1 RNA <50 copies/mL at the Week 48 and Week 96 visits and the screening tropism test (Genotype test or Enhanced Sensitivity Trofile Assay [ESTA]).

Virologic Response: Proportion of patients with plasma HIV RNA <50 copies/mL at Week 96.

Immunological Response at Week 48 and Week 96: a.Changes in CD4+ T lymphocyte (CD4) cell counts and percent change from Baseline; b.Changes in CD8+ T lymphocyte (CD8) cell counts and percent change from Baseline; c.Changes in CD4+/CD8+ ratio and

changes from Baseline.

Evolution of viral resistance and tropism change between Screening or Baseline and the time of confirmation of virologic failure or the last on treatment time point: a.HIV 1 tropism (Genotype test) b.For virologic failure with R5 virus, viral

resistance to maraviroc (maraviroc treated patients only). c.Viral resistance (Genotype and Phenotype) to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and non nucleoside reverse transcriptase inhibitors (NNRTI) [reverse transcriptase

inhibitors, RTI] and protease inhibitors (PI).

Changes in peripheral fat distribution and trunk to limb fat ratio (using Dual Energy X-ray Absorptiometry [DEXA] scan) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm).

Changes in bone mineral density (using DEXA scan and serum markers) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm).

Detailed description: The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening

Visit.

- CD4 count equal to or greater than 100 cells/mm3 at Screening.

- Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at

any time.

- Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and

emtricitabine.

- CXCR4 using virus detected using randomized tropism determination or repeated failure

to obtain an interpretable tropism result.

Locations and Contacts

AKH Wien Universitaetsklinik fuer Dermatologie, Wien 1090, Austria

Instituut voor Tropische Geneeskunde, Antwerpen B-2000, Belgium

C.H.U. St-Pierre, Brussels 1000, Belgium

Cliniques Universitaires St-Luc, Brussels 1200, Belgium

Hôpital Universitaire Erasme, Bruxelles 1070, Belgium

Universitair Ziekenhuis Gent, Gent B-9000, Belgium

C.H.U. Sart-Tilman, Liege 4000, Belgium

Hvidovre Hospital, Infektionsmedicinsk afd., Hvidovre 2650, Denmark

Rigshospitalet, Epidemiklinikken, Koebenhavn OE 2100, Denmark

Odense Universitetshospital, Odense 5000, Denmark

Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs, Helsinki 00250, Finland

Hopital Saint-andre, Bordeaux cedex 33075, France

Hopital Henri Mondor, Creteil 94000, France

Hopital Bicetre, Le Kremlin Bicetre 94275, France

Hopital de la Croix Rousse, LYON Cedex 4 69317, France

Hopital Gui de Chauliac, Montpellier 34295, France

CHU de Nantes - Hotel Dieu, Nantes 44035, France

Hopital Saint-Louis, Paris Cedex 10 75475, France

Hopital Tenon, Service des Maladies Infectieuses, Paris 75020, France

Hôpital de la Pitié Salpétrière, Paris 75013, France

Nouvel Hopital Civil, Strasbourg Cedex 67091, France

CHU de Tourcoing, Tourcoing 59208, France

EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH, Berlin 12157, Germany

Praxis Christiane Cordes, Berlin 10243, Germany

Studiengesellschaft mbH Gubener 37, Berlin 10243, Germany

Universitaetsklinikum Bonn, Immunologische Ambulanz HIV, Bonn 53127, Germany

InfektioResearch GmbH & Co. KG, Frankfurt am Main 60596, Germany

Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II, Frankfurt am Main 60590, Germany

ICH - Study - Center GmbH & Co. KG, Hamburg 20146, Germany

ifi - Studien und Projekte GmbH, Hamburg 20099, Germany

Universitaetsklinikum Hamburg-Eppendorf, Hamburg 20246, Germany

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin, Koeln 50937, Germany

Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt, Muenchen 80336, Germany

MUC Research Group GbR, Muenchen 80335, Germany

Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet / V. Fertozo Belgyogyaszati Osztaly, Budapest 1097, Hungary

Ospedale San Raffaele, Milano 20127, Italy

University Medical Center Utrecht, Utrecht 3584 CX, Netherlands

Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza, Bydgoszcz 85-030, Poland

SPZOZ Wojewodzki Szpital Zakazny, Warszawa 01-201, Poland

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej, Wroclaw 50-220, Poland

Hospital Prof. Doutor Fernando Fonseca E.P.E., Amadora 2720-276, Portugal

Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos, Lisboa 1169-050, Portugal

Hospital Sta. Maria, Lisboa 1649-035, Portugal

Hospital São João, Porto 4200-319, Portugal

Innovative Care PSC, Bayamon 00959, Puerto Rico

Ararat Research Center, Ponce 00717, Puerto Rico

University of Puerto Rico Medical Sciences Campus, Rio Piedras 00935, Puerto Rico

Clinical Research Puerto Rico, San Juan 00909, Puerto Rico

HOPE Clinical Research, San Juan 00909, Puerto Rico

UPR - CTU Pharmacy, San Juan 00935, Puerto Rico

Hospital General Universitario de Alicante, Alicante 03010, Spain

Hospital Clinic I Provincial de Barcelona, Barcelona 08036, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Universitario Reina Sofia - Hospital Provincial, Cordoba 14004, Spain

Hospital General Universitario Gregorio Marañon, Madrid 28007, Spain

Hospital Universitario de La Paz, Madrid 28046, Spain

Hospital Universitario Virgen de la Macarena, Sevilla 41007, Spain

SU Ostra sjukhuset, Infektionsmottagningen, Goteborg 416 85, Sweden

Skanes Universitetssjukhus, Malmo 205 02, Sweden

Karolinska Universitetssjukhuset Huddinge, Stockholm 141 86, Sweden

Sodersjukhuset, Venhalsan, Stockholm 118 83, Sweden

Kantonsspital Basel, Basel 4031, Switzerland

Inselspital Bern, Bern 3010, Switzerland

Kantonsspital St. Gallen, St. Gallen 9007, Switzerland

Universitatsspital Zurich, Zurich 8091, Switzerland

Dept of Sexual Health & HIV Medicine, Birmingham B9 5SS, United Kingdom

HIV Research Department, Elton John Centre, Brighton BN2 1ES, United Kingdom

Regional Infectious Diseases Unit, Edinburgh EH4 2XU, United Kingdom

Centre for Sexual Health & HIV Research, University College London, London WC1E 6AU, United Kingdom

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,, London E1 1BB, United Kingdom

Ian Charleson Day Centre, Royal Free Hospital, London NW3 2QG, United Kingdom

Queen Elizabeth Hospital, London SE18 4QH, United Kingdom

St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust, London SW10 9NH, United Kingdom

Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals, Manchester M8 5RB, United Kingdom

University of Alabama at Birmingham - 1917 Research Clinic, Birmingham, Alabama 35294, United States

Health Services Center, Hobson City, Alabama 36201, United States

Hospital Universitari de Bellvitge, L´hospitalet de Llobregat, Barcelona 08907, Spain

Vancouver ID Research and Care Centre Society, Vancouver, British Columbia V6Z 2C7, Canada

Kaiser Permanente, Hayward, California 94545, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Dr. Anthony Mills, MD, Inc., Los Angeles, California 90069, United States

Orange Coast Medical Group, Newport Beach, California 92663, United States

Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group, Palm Springs, California 92262, United States

Desert Oasis Healthcare Medical Group, Palm Springs, California 92262, United States

Kaiser Hospital Sacramento, Sacramento, California 95825, United States

TICON I Research Clinic (DEXA Scan only), Sacramento, California 95817, United States

University of California Davis Research, Sacramento, California 95814, United States

Investigational Drugs Pharmacy, San Francisco, California 94118, United States

Kaiser Permanente - Clinical Trials Unit, San Francisco, California 94118, United States

Kaiser Permanente Santa Clara, Santa Clara, California 95051, United States

Kaiser Permanente, Union City, California 94587, United States

CHR d'Orleans la Source, Orleans, Cedex 02 45067, France

Hopital Saint Antoine, Paris, Cedex 12 75571, France

Hopital Bichat, Paris, Cedex 18 75877, France

University of Colorado Denver - University of Colorado Hospital, Aurora, Colorado 80045, United States

Kaiser Permanente of Colorado, Denver, Colorado 80205, United States

Yale - New Haven Hospital Nathan Smith Clinic, New Haven, Connecticut 06504, United States

Yale University, New Haven, Connecticut 06510, United States

Circle CARE Center, Norwalk, Connecticut 06851, United States

Capital Medical Associates, PC, Washington, District of Columbia 20036, United States

George Washington University Medical Faculty Associates, Washington, District of Columbia 20037, United States

Broward Health - Comprehensive Care Center, Fort Lauderdale, Florida 33311, United States

Wohlfeiler, Piperato and Associates, LLC, Miami Beach, Florida 33139, United States

Community AIDS Resource Inc dba Care Resource, Miami, Florida 33137, United States

Miami Research Associates, Miami, Florida 33143, United States

The Kinder Medical Group, Miami, Florida 33133, United States

UMHC/Sylvester Comprehensive Cancer Center, Miami, Florida 33136, United States

University of Miami - IDCRU, Miami, Florida 33136, United States

University of Miami AIDS Clinical Research Unit, Miami, Florida 33136, United States

Infectious Diseases Associates of Northwest Florida, PA, Pensacola, Florida 32504, United States

Infectious Disease Research Institute, Inc., Tampa, Florida 33614, United States

Osteoporosis Care Center, Tampa, Florida 33614, United States

Quest Diagnostic Laboratory, Tampa, Florida 33614, United States

St. Joseph's Hospital Diagnostic Center, Tampa, Florida 33067, United States

University of South Florida Health-HIV Clinical Research Unit, Tampa, Florida 33602, United States

Rowan Tree Medical, PA, Wilton Manors, Florida 33305, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

DeKalb Medical Diagnostic Breast Center, Decatur, Georgia 30033, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

Howard Brown Health Center, Chicago, Illinois 60613, United States

Northwestern University, Chicago, Illinois 60611, United States

Northwestern University/NMH, Chicago, Illinois 60611, United States

University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease, Iowa City, Iowa 52242, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Baystate Infectious Diseases Clinical Research, Springfield, Massachusetts 01199, United States

Be Well Medical Center, PC, Berkley, Michigan 48072, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

University Physicians Group, Detroit, Michigan 48201, United States

Wayne State University, Detroit, Michigan 48201, United States

Michigan State University College of Osteopathic Medicine - Department of Internal Medicine, East Lansing, Michigan 48824, United States

Ingham County Health Department, Lansing, Michigan 48911, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Kansas City Free Health Clinic, Kansas City, Missouri 64111, United States

University of Nebraska Medical Center, Omaha, Nebraska 68106, United States

Jersey Shore University Medical Center, Neptune, New Jersey 07753, United States

Saint Michael's Medical Center, Newark, New Jersey 07102, United States

East Sydney Doctors, Darlinghurst, New South Wales 2010, Australia

Holdsworth House General Practice, Darlinghurst, New South Wales 2010, Australia

IBAC, Darlinghurst, New South Wales 2010, Australia

Taylor Square Private Clinic, Surry Hills, New South Wales 2010, Australia

Erie County Medical Center, Buffalo, New York 14215, United States

AIDS Community Research Initiative of America (ACRIA), New York, New York 10018, United States

Beth Israel Medical Center - AIDS Clinical Trials Unit, New York, New York 10003, United States

Dr. Howard A. Grossman, M.D., New York, New York 10107, United States

Research Across America, New York, New York 10022, United States

AIDS Care, Rochester, New York 14607, United States

New York Medical College, Valhalla, New York 10595, United States

I.D. Consultants, P.A., Charlotte, North Carolina 28209, United States

East Carolina University Division of Infectious Diseases, Greenville, North Carolina 27834, United States

University of Cincinnati - Department of Internal Medicine, Cincinnati, Ohio 45267, United States

The University of Toledo Medical Center, Toledo, Ohio 43614, United States

The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada

The Ottawa Hospital-Riverside Campus, Ottawa, Ontario K1H 7W9, Canada

Maple Leaf Research / Maple Leaf Medical Clinic, Toronto, Ontario M5G 1K2, Canada

University Health Network / Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada

Clinique Medicale du Quartier Latin, Montreal, Quebec H2L 5B1, Canada

Clinique Medicale L'Actuel, Montreal, Quebec H2L 4P9, Canada

Brisbane Sexual Health and HIV Service, Brisbane, Queensland 4000, Australia

Central Texas Clinical Research, Austin, Texas 78705, United States

North Texas Infectious Diseases Consultants, PA, Dallas, Texas 75246, United States

Parkland Memorial Hospital, Dallas, Texas 75235, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States

Research Access Network, Houston, Texas 77098, United States

The Office of Dr. Gordon E. Crofoot, M.D., PA, Houston, Texas 77098, United States

Therapeutic Concepts, PA, Houston, Texas 77004, United States

Melbourne Sexual Health Centre, Carlton, Victoria 3053, Australia

Clinical Research Unit, Infectious Diseases, Melbourne, Victoria 3004, Australia

Swedish Medical Center, Seattle, Washington 98104, United States

Swedish Medical Center, Seattle, Washington 98122, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2011
Last updated: February 20, 2014

Page last updated: August 23, 2015

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