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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 (MODERN)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01345630
First received: April 27, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
HIV-1
Drug: Maraviroc
Drug: Emtricitabine/tenofovir
Phase 3

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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • The proportion of subjects with plasma HIV 1 RNA <50 copies/mL at Week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Number of subjects who meet the primary endpoint.


Secondary Outcome Measures:
  • 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. [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
    Number of subjects who meet the specified endpoint

  • 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]). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Virologic Response: Proportion of patients with plasma HIV RNA <50 copies/mL at Week 96. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • changes from Baseline. [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • inhibitors, RTI] and protease inhibitors (PI). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Changes in bone mineral density (using DEXA scan and serum markers) from Baseline and at Weeks 48 and 96 (107 patients per treatment arm). [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]

Enrollment: 804
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc
Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Drug: Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.
Other Name: Selzentry, Celsentri
Active Comparator: Emtricitabine/tenofovir
Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Drug: Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
Other Name: Truvada

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345630

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama, United States, 35294
Health Services Center
Hobson City, Alabama, United States, 36201
United States, California
Kaiser Permanente
Hayward, California, United States, 94545
Dr. Anthony Mills, MD, Inc.
Los Angeles, California, United States, 90069
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Orange Coast Medical Group
Newport Beach, California, United States, 92663
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
TICON I Research Clinic (DEXA Scan only)
Sacramento, California, United States, 95817
University of California Davis Research
Sacramento, California, United States, 95814
Kaiser Hospital Sacramento
Sacramento, California, United States, 95825
Investigational Drugs Pharmacy
San Francisco, California, United States, 94118
Kaiser Permanente - Clinical Trials Unit
San Francisco, California, United States, 94118
Kaiser Permanente Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente
Union City, California, United States, 94587
United States, Colorado
University of Colorado Denver - University of Colorado Hospital
Aurora, Colorado, United States, 80045
Kaiser Permanente of Colorado
Denver, Colorado, United States, 80205
United States, Connecticut
Yale - New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut, United States, 06504
Yale University
New Haven, Connecticut, United States, 06510
Circle CARE Center
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Broward Health - Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136
Community AIDS Resource Inc dba Care Resource
Miami, Florida, United States, 33137
Miami Research Associates
Miami, Florida, United States, 33143
The Kinder Medical Group
Miami, Florida, United States, 33133
UMHC/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
University of Miami - IDCRU
Miami, Florida, United States, 33136
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Infectious Diseases Associates of Northwest Florida, PA
Pensacola, Florida, United States, 32504
University of South Florida Health-HIV Clinical Research Unit
Tampa, Florida, United States, 33602
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States, 33614
Osteoporosis Care Center
Tampa, Florida, United States, 33614
St. Joseph's Hospital Diagnostic Center
Tampa, Florida, United States, 33067
Quest Diagnostic Laboratory
Tampa, Florida, United States, 33614
Rowan Tree Medical, PA
Wilton Manors, Florida, United States, 33305
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
DeKalb Medical Diagnostic Breast Center
Decatur, Georgia, United States, 30033
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Northwestern University
Chicago, Illinois, United States, 60611
Northwestern University/NMH
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
United States, Michigan
Be Well Medical Center, PC
Berkley, Michigan, United States, 48072
Henry Ford Health System
Detroit, Michigan, United States, 48202
Wayne State University
Detroit, Michigan, United States, 48201
University Physicians Group
Detroit, Michigan, United States, 48201
Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
East Lansing, Michigan, United States, 48824
Ingham County Health Department
Lansing, Michigan, United States, 48911
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Kansas City Free Health Clinic
Kansas City, Missouri, United States, 64111
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68106
United States, New Jersey
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
Erie County Medical Center
Buffalo, New York, United States, 14215
AIDS Community Research Initiative of America (ACRIA)
New York, New York, United States, 10018
Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York, United States, 10003
Dr. Howard A. Grossman, M.D.
New York, New York, United States, 10107
Research Across America
New York, New York, United States, 10022
AIDS Care
Rochester, New York, United States, 14607
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
I.D. Consultants, P.A.
Charlotte, North Carolina, United States, 28209
East Carolina University Division of Infectious Diseases
Greenville, North Carolina, United States, 27834
United States, Ohio
University of Cincinnati - Department of Internal Medicine
Cincinnati, Ohio, United States, 45267
The University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States, 75246
Research Access Network
Houston, Texas, United States, 77098
The Office of Dr. Gordon E. Crofoot, M.D., PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia, New South Wales
East Sydney Doctors
Darlinghurst, New South Wales, Australia, 2010
Holdsworth House General Practice
Darlinghurst, New South Wales, Australia, 2010
IBAC
Darlinghurst, New South Wales, Australia, 2010
Taylor Square Private Clinic
Surry Hills, New South Wales, Australia, 2010
Australia, Queensland
Brisbane Sexual Health and HIV Service
Brisbane, Queensland, Australia, 4000
Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Clinical Research Unit, Infectious Diseases
Melbourne, Victoria, Australia, 3004
Austria
AKH Wien Universitaetsklinik fuer Dermatologie
Wien, Austria, 1090
Belgium
Instituut voor Tropische Geneeskunde
Antwerpen, Belgium, B-2000
C.H.U. St-Pierre
Brussels, Belgium, 1000
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Hôpital Universitaire Erasme
Bruxelles, Belgium, 1070
Universitair Ziekenhuis Gent
Gent, Belgium, B-9000
C.H.U. Sart-Tilman
Liege, Belgium, 4000
Canada, British Columbia
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
The Ottawa Hospital-Riverside Campus
Ottawa, Ontario, Canada, K1H 7W9
Maple Leaf Research / Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5G 1K2
University Health Network / Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Clinique Medicale L'Actuel
Montreal, Quebec, Canada, H2L 4P9
Denmark
Hvidovre Hospital, Infektionsmedicinsk afd.
Hvidovre, Denmark, 2650
Rigshospitalet, Epidemiklinikken
Koebenhavn OE, Denmark, 2100
Odense Universitetshospital
Odense, Denmark, 5000
Finland
Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs
Helsinki, Finland, 00250
France
CHR d'Orleans la Source
Orleans, Cedex 02, France, 45067
Hopital Saint Antoine
Paris, Cedex 12, France, 75571
Hopital Bichat
Paris, Cedex 18, France, 75877
Hopital Saint-andre
Bordeaux cedex, France, 33075
Hopital Henri Mondor
Creteil, France, 94000
Hopital Bicetre
Le Kremlin Bicetre, France, 94275
Hopital de la Croix Rousse
LYON Cedex 4, France, 69317
Hopital Gui de Chauliac
Montpellier, France, 34295
CHU de Nantes - Hotel Dieu
Nantes, France, 44035
Hopital Tenon, Service des Maladies Infectieuses
Paris, France, 75020
Hôpital de la Pitié Salpétrière
Paris, France, 75013
Hopital Saint-Louis
Paris Cedex 10, France, 75475
Nouvel Hopital Civil
Strasbourg Cedex, France, 67091
CHU de Tourcoing
Tourcoing, France, 59208
Germany
EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Berlin, Germany, 12157
Praxis Christiane Cordes
Berlin, Germany, 10243
Studiengesellschaft mbH Gubener 37
Berlin, Germany, 10243
Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
Bonn, Germany, 53127
InfektioResearch GmbH & Co. KG
Frankfurt am Main, Germany, 60596
Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt am Main, Germany, 60590
ICH - Study - Center GmbH & Co. KG
Hamburg, Germany, 20146
ifi - Studien und Projekte GmbH
Hamburg, Germany, 20099
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
Koeln, Germany, 50937
Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt
Muenchen, Germany, 80336
MUC Research Group GbR
Muenchen, Germany, 80335
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet / V. Fertozo Belgyogyaszati Osztaly
Budapest, Hungary, 1097
Italy
Ospedale San Raffaele
Milano, Italy, 20127
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza
Bydgoszcz, Poland, 85-030
SPZOZ Wojewodzki Szpital Zakazny
Warszawa, Poland, 01-201
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, Poland, 50-220
Portugal
Hospital Prof. Doutor Fernando Fonseca E.P.E.
Amadora, Portugal, 2720-276
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
Lisboa, Portugal, 1169-050
Hospital Sta. Maria
Lisboa, Portugal, 1649-035
Hospital São João
Porto, Portugal, 4200-319
Puerto Rico
Innovative Care PSC
Bayamon, Puerto Rico, 00959
Ararat Research Center
Ponce, Puerto Rico, 00717
University of Puerto Rico Medical Sciences Campus
Rio Piedras, Puerto Rico, 00935
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
HOPE Clinical Research
San Juan, Puerto Rico, 00909
UPR - CTU Pharmacy
San Juan, Puerto Rico, 00935
Spain
Hospital Universitari de Bellvitge
L´hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Reina Sofia - Hospital Provincial
Cordoba, Spain, 14004
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario de La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Macarena
Sevilla, Spain, 41007
Sweden
SU Ostra sjukhuset, Infektionsmottagningen
Goteborg, Sweden, 416 85
Skanes Universitetssjukhus
Malmo, Sweden, 205 02
Sodersjukhuset, Venhalsan
Stockholm, Sweden, 118 83
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 141 86
Switzerland
Kantonsspital Basel
Basel, Switzerland, 4031
Inselspital Bern
Bern, Switzerland, 3010
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Universitatsspital Zurich
Zurich, Switzerland, 8091
United Kingdom
Dept of Sexual Health & HIV Medicine
Birmingham, United Kingdom, B9 5SS
HIV Research Department, Elton John Centre
Brighton, United Kingdom, BN2 1ES
Regional Infectious Diseases Unit
Edinburgh, United Kingdom, EH4 2XU
Centre for Sexual Health & HIV Research, University College London
London, United Kingdom, WC1E 6AU
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,
London, United Kingdom, E1 1BB
Ian Charleson Day Centre, Royal Free Hospital
London, United Kingdom, NW3 2QG
Queen Elizabeth Hospital
London, United Kingdom, SE18 4QH
St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01345630     History of Changes
Other Study ID Numbers: A4001095
Study First Received: April 27, 2011
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
Double-blind
comparative
trial
maraviroc
versus
emtricitabine/tenofovir
both with darunavir/ritonavir
antiretroviral-naive
Ccr5 tropic
Hiv 1
patients.

Additional relevant MeSH terms:
Darunavir
Emtricitabine
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014