Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

NCT01345630 | Terminated Phase 3 Results DMC

• 2 other identifiers: A40010952010-021785-30
• Study Type: interventional
• Target: 813
• Locations: 18 countries
• Sites: 170

Brief 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.

Conditions

HIV-1

Keywords

Double-blind; comparative; trial; maraviroc; versus; emtricitabine/tenofovir; both with darunavir/ritonavir; antiretroviral-naive; Ccr5 tropic; Hiv 1; patients.

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.

  The proportion of participants who achieved HIV-1 RNA \<50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.

  Week 48

Secondary Outcomes (24)

• Frequency of Adverse Events (AE).

  Week 96

• Number of Participants With Grade 3 or 4 AEs

  Week 96

• Number of Participants Who Discontinued Due to AEs

  Week 96

• Number of Treatment-related AEs

  Week 96

• Number of Participants With Treatment-emergent Serious Adverse Events

  Week 96

Study Arms (2)

Maraviroc

EXPERIMENTAL

Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.

Drug: Maraviroc; Drug: darunavir/ritonavir 800/100 mg; Drug: placebo for maraviroc

Emtricitabine/tenofovir

ACTIVE COMPARATOR

Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.

Drug: Emtricitabine/tenofovir; Drug: placebo for emtricitabine/tenofovir

Interventions

Maraviroc DRUG

Maraviroc tablet 150 mg once daily for 96 weeks.

Also known as: Selzentry, Celsentri

Maraviroc

Emtricitabine/tenofovir DRUG

Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.

Also known as: Truvada

Emtricitabine/tenofovir

darunavir/ritonavir 800/100 mg DRUG

darunavir/ritonavir 800/100 mg

Maraviroc

placebo for emtricitabine/tenofovir DRUG

placebo for emtricitabine/tenofovir

Also known as: Truvada

Emtricitabine/tenofovir

placebo for maraviroc DRUG

placebo for maraviroc

Also known as: Selzentry, Celsentri

Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (177)

University of Alabama at Birmingham - 1917 Research Clinic

Birmingham, Alabama, 35294, United States

Location

Health Services Center

Hobson City, Alabama, 36201, United States

Location

Kaiser Permanente

Hayward, California, 94545, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Dr. Anthony Mills, MD, Inc.

Los Angeles, California, 90069, United States

Location

Orange Coast Medical Group

Newport Beach, California, 92663, United States

Location

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

University of California Davis Research

Sacramento, California, 95814, United States

Location

TICON I Research Clinic (DEXA Scan only)

Sacramento, California, 95817, United States

Location

Kaiser Hospital Sacramento

Sacramento, California, 95825, United States

Location

Synarc Inc.

San Francisco, California, 94105, United States

Location

Investigational Drugs Pharmacy

San Francisco, California, 94118, United States

Location

Kaiser Permanente - Clinical Trials Unit

San Francisco, California, 94118, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente

Union City, California, 94587, United States

Location

University of Colorado Denver - University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Kaiser Permanente of Colorado

Denver, Colorado, 80205, United States

Location

Yale - New Haven Hospital Nathan Smith Clinic

New Haven, Connecticut, 06504, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Circle CARE Center

Norwalk, Connecticut, 06851, United States

Location

Capital Medical Associates, PC

Washington D.C., District of Columbia, 20036, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Broward Health - Comprehensive Care Center

Fort Lauderdale, Florida, 33311, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

UMHC/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Miami AIDS Clinical Research Unit

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Community AIDS Resource Inc dba Care Resource

Miami, Florida, 33137, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Wohlfeiler, Piperato and Associates, LLC

Miami Beach, Florida, 33139, United States

Location

Infectious Diseases Associates of Northwest Florida, PA

Pensacola, Florida, 32504, United States

Location

St. Joseph's Hospital Diagnostic Center

Tampa, Florida, 33067, United States

Location

University of South Florida Health-HIV Clinical Research Unit

Tampa, Florida, 33602, United States

Location

Infectious Disease Research Institute, Inc.

Tampa, Florida, 33614, United States

Location

Osteoporosis Care Center

Tampa, Florida, 33614, United States

Location

Quest Diagnostic Laboratory

Tampa, Florida, 33614, United States

Location

Rowan Tree Medical, PA

Wilton Manors, Florida, 33305, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30312, United States

Location

DeKalb Medical Diagnostic Breast Center

Decatur, Georgia, 30033, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Northwestern University/NMH

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease

Iowa City, Iowa, 52242, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Baystate Infectious Diseases Clinical Research

Springfield, Massachusetts, 01199, United States

Location

Be Well Medical Center, PC

Berkley, Michigan, 48072, United States

Location

University Physicians Group

Detroit, Michigan, 48201, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Michigan State University College of Osteopathic Medicine - Department of Internal Medicine

East Lansing, Michigan, 48824, United States

Location

Biomedical and Health Institutional Review Board

East Lansing, Michigan, 48825, United States

Location

Ingham County Health Department

Lansing, Michigan, 48911, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Kansas City Free Health Clinic

Kansas City, Missouri, 64111, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Brandywine Common

Neptune City, New Jersey, 07754, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Beth Israel Medical Center - AIDS Clinical Trials Unit

New York, New York, 10003, United States

Location

AIDS Community Research Initiative of America (ACRIA)

New York, New York, 10018, United States

Location

Research Across America

New York, New York, 10022, United States

Location

Dr. Howard A. Grossman, M.D.

New York, New York, 10107, United States

Location

AIDS Care

Rochester, New York, 14607, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

I.D. Consultants, P.A.

Charlotte, North Carolina, 28209, United States

Location

(DEXA Scan Facility) East Carolina University Brody Outpatient Center

Greenville, North Carolina, 27834, United States

Location

East Carolina University Division of Infectious Diseases

Greenville, North Carolina, 27834, United States

Location

University of Cincinnati - Department of Internal Medicine

Cincinnati, Ohio, 45267, United States

Location

The University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, 75246, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

Research Access Network

Houston, Texas, 77098, United States

Location

The Office of Dr. Gordon E. Crofoot, M.D., PA

Houston, Texas, 77098, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

Holdsworth House General Practice

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Surry Hills, New South Wales, 2010, Australia

Location

Brisbane Sexual Health and HIV Service

Brisbane, Queensland, 4000, Australia

Location

Melbourne Sexual Health Centre

Carlton, Victoria, 3053, Australia

Location

Clinical Research Unit, Infectious Diseases

Melbourne, Victoria, 3004, Australia

Location

AKH Wien Universitaetsklinik fuer Dermatologie

Vienna, 1090, Austria

Location

Instituut voor Tropische Geneeskunde

Antwerp, B-2000, Belgium

Location

C.H.U. St-Pierre

Brussels, 1000, Belgium

Location

Hôpital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

C.H.U. Sart-Tilman

Liège, 4000, Belgium

Location

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z 2C7, Canada

Location

The Ottawa Hospital-Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Maple Leaf Research / Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

University Health Network / Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Clinique Medicale L'Actuel

Montreal, Quebec, H2L 4P9, Canada

Location

Clinique Medicale du Quartier Latin

Montreal, Quebec, H2L 5B1, Canada

Location

Hvidovre Hospital, Infektionsmedicinsk afd.

Hvidovre, 2650, Denmark

Location

Rigshospitalet, Epidemiklinikken

Koebenhavn OE, 2100, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs

Helsinki, 00250, Finland

Location

CHR d'Orleans la Source

Orléans, Cedex 02, 45067, France

Location

Hopital Saint Antoine

Paris, Cedex 12, 75571, France

Location

Hopital Bichat

Paris, Cedex 18, 75877, France

Location

Hopital Saint-andre

Bordeaux, France, 33075, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Hopital Gui de Chauliac

Montpellier, 34295, France

Location

CHU de Nantes - Hotel Dieu

Nantes, 44035, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75013, France

Location

Hopital Tenon, Service des Maladies Infectieuses

Paris, 75020, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Centre Hospitalier de Tourcoing

Tourcoing, 59208, France

Location

Praxis Christiane Cordes

Berlin, 10243, Germany

Location

Studiengesellschaft mbH Gubener 37

Berlin, 10243, Germany

Location

EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

Berlin, 12157, Germany

Location

Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

Bonn, 53127, Germany

Location

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

Cologne, 50937, Germany

Location

Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II

Frankfurt am Main, 60590, Germany

Location

InfektioResearch GmbH & Co. KG

Frankfurt am Main, 60596, Germany

Location

ifi - Studien und Projekte GmbH

Hamburg, 20099, Germany

Location

ICH - Study - Center GmbH & Co. KG

Hamburg, 20146, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MUC Research Group GbR

München, 80335, Germany

Location

Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt

München, 80336, Germany

Location

Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

Budapest, 1097, Hungary

Location

Ospedale San Raffaele

Milan, 20127, Italy

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza

Bydgoszcz, 85-030, Poland

Location

SPZOZ Wojewodzki Szpital Zakazny

Warsaw, 01-201, Poland

Location

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

Wroclaw, 50-220, Poland

Location

Hospital Prof. Doutor Fernando Fonseca E.P.E.

Amadora, Portugal, 2720-276, Portugal

Location

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

Lisbon, 1169-050, Portugal

Location

Hospital Sta. Maria

Lisbon, 1649-035, Portugal

Location

Hospital São João

Porto, 4200-319, Portugal

Location

Innovative Care PSC

Bayamón, PR, 00959, Puerto Rico

Location

Ararat Research Center

Ponce, PR, 00717, Puerto Rico

Location

Medical Center University Hospital

Rio Piedras, PR, 00935, Puerto Rico

Location

Clinical Research Puerto Rico

San Juan, PR, 00909, Puerto Rico

Location

HOPE Clinical Research

San Juan, PR, 00909, Puerto Rico

Location

University of Puerto Rico Medical Sciences Campus

Rio Piedras, 00935, Puerto Rico

Location

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Reina Sofia - Hospital Provincial

Córdoba, Cordoba, 14004, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario de La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, 41007, Spain

Location

SU Ostra sjukhuset, Infektionsmottagningen

Gothenburg, 416 85, Sweden

Location

Skanes Universitetssjukhus

Malmo, 205 02, Sweden

Location

Sodersjukhuset, Venhalsan

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

Universitaetsspital Basel Infektiologie und Spitalhygiene

Basel, 4031, Switzerland

Location

Inselspital Universitaetsklinik fuer Infektiologie

Bern, 3010, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Universitatsspital Zurich

Zurich, 8091, Switzerland

Location

Dept of Sexual Health & HIV Medicine

Birmingham, B9 5SS, United Kingdom

Location

HIV Research Department, Elton John Centre

Brighton, BN2 1ES, United Kingdom

Location

Regional Infectious Diseases Unit

Edinburgh, EH4 2XU, United Kingdom

Location

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,

London, E1 1BB, United Kingdom

Location

Ian Charleson Day Centre, Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Queen Elizabeth Hospital

London, SE18 4QH, United Kingdom

Location

St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Centre for Sexual Health & HIV Research, University College London

London, WC1E 6AU, United Kingdom

Location

Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals

Manchester, M8 5RB, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Darunavir; Ritonavir; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles

Limitations and Caveats

The study was terminated following a preliminary review of the 48- week primary clinical efficacy data by the study's external independent Data Monitoring Committee's recommendation based on inferior efficacy of the investigational MVC+DRV/r arm.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 2, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

ES (9); CH (4); NL (1); AU (1); BE (6); CA (7); US (84); FR (14); PR (6); FI (1); GB (9); IT (1); HU (1); DE (12); PT (4); DK (3); PL (3); SE (4)