Clinical trial NCT01345630: Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Official title: A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV-1
Keywords: Double-blind
comparative
trial
maraviroc
versus
emtricitabine/tenofovir
both with darunavir/ritonavir
antiretroviral-naive
Ccr5 tropic
Hiv 1
patients.
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-05-02
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
timeFrame: Week 48
Secondary outcomes:
measure: Frequency of Adverse Events (AE).
timeFrame: Week 96
measure: Number of Participants With Grade 3 or 4 AEs
timeFrame: Week 96
measure: Number of Participants Who Discontinued Due to AEs
timeFrame: Week 96
measure: Number of Treatment-related AEs
timeFrame: Week 96
measure: Number of Participants With Treatment-emergent Serious Adverse Events
timeFrame: Week 96
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Week 96
measure: Severity of Abnormal Laboratory Values
timeFrame: Week 96
measure: The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
timeFrame: Week 48
measure: Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
timeFrame: Week 48
measure: Tropism Change Between Screening or Baseline and PDTF
timeFrame: Week 48
measure: Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
timeFrame: Week 48
measure: Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
timeFrame: Week 48
measure: Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
timeFrame: Baseline, Week 48
measure: Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
timeFrame: Baseline, Week 48
measure: Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
timeFrame: Baseline, Week 48
measure: Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
timeFrame: Baseline, Week 48
measure: Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
timeFrame: Baseline, Week 48
measure: Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
timeFrame: Week 48
measure: Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
timeFrame: Week 48
measure: Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
timeFrame: Week 48
measure: Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
timeFrame: Week 48
measure: Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
timeFrame: Week 48
measure: Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
timeFrame: Week 48
measure: Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
timeFrame: Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - 1917 Research Clinic
state: Alabama
city: Hobson City
country: United States
facility: Health Services Center
state: Alabama
city: Hayward
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Dr. Anthony Mills, MD, Inc.
state: California
city: Newport Beach
country: United States
facility: Orange Coast Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Sacramento
country: United States
facility: University of California Davis Research
state: California
city: Sacramento
country: United States
facility: TICON I Research Clinic (DEXA Scan only)
state: California
city: Sacramento
country: United States
facility: Kaiser Hospital Sacramento
state: California
city: San Francisco
country: United States
facility: Synarc Inc.
state: California
city: San Francisco
country: United States
facility: Investigational Drugs Pharmacy
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - Clinical Trials Unit
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Union City
country: United States
facility: Kaiser Permanente
state: California
city: Aurora
country: United States
facility: University of Colorado Denver - University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale - New Haven Hospital Nathan Smith Clinic
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Norwalk
country: United States
facility: Circle CARE Center
state: Connecticut
city: Washington
country: United States
facility: Capital Medical Associates, PC
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Broward Health - Comprehensive Care Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Wohlfeiler, Piperato and Associates, LLC
state: Florida
city: Miami
country: United States
facility: The Kinder Medical Group
state: Florida
city: Miami
country: United States
facility: UMHC/Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami AIDS Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Community AIDS Resource Inc dba Care Resource
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Pensacola
country: United States
facility: Infectious Diseases Associates of Northwest Florida, PA
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital Diagnostic Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health-HIV Clinical Research Unit
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute, Inc.
state: Florida
city: Tampa
country: United States
facility: Osteoporosis Care Center
state: Florida
city: Tampa
country: United States
facility: Quest Diagnostic Laboratory
state: Florida
city: Wilton Manors
country: United States
facility: Rowan Tree Medical, PA
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Diagnostic Breast Center
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern University/NMH
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
state: Iowa
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Springfield
country: United States
facility: Baystate Infectious Diseases Clinical Research
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center, PC
state: Michigan
city: Detroit
country: United States
facility: University Physicians Group
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
state: Michigan
city: East Lansing
country: United States
facility: Biomedical and Health Institutional Review Board
state: Michigan
city: Lansing
country: United States
facility: Ingham County Health Department
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Free Health Clinic
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Brandywine Common
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center - AIDS Clinical Trials Unit
state: New York
city: New York
country: United States
facility: AIDS Community Research Initiative of America (ACRIA)
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: New York
country: United States
facility: Dr. Howard A. Grossman, M.D.
state: New York
city: Rochester
country: United States
facility: AIDS Care
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Charlotte
country: United States
facility: I.D. Consultants, P.A.
state: North Carolina
city: Greenville
country: United States
facility: (DEXA Scan Facility) East Carolina University Brody Outpatient Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University Division of Infectious Diseases
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati - Department of Internal Medicine
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, PA
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, PA
state: Texas
city: Houston
country: United States
facility: Research Access Network
state: Texas
city: Houston
country: United States
facility: The Office of Dr. Gordon E. Crofoot, M.D., PA
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House General Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Surry Hills
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Brisbane
country: Australia
facility: Brisbane Sexual Health and HIV Service
state: Queensland
city: Carlton
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
city: Melbourne
country: Australia
facility: Clinical Research Unit, Infectious Diseases
state: Victoria
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Dermatologie
city: Antwerpen
country: Belgium
facility: Instituut voor Tropische Geneeskunde
city: Brussels
country: Belgium
facility: C.H.U. St-Pierre
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Bruxelles
country: Belgium
facility: Hôpital Universitaire Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: C.H.U. Sart-Tilman
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Riverside Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research / Maple Leaf Medical Clinic
state: Ontario
city: Toronto
country: Canada
facility: University Health Network / Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuel
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Infektionsmedicinsk afd.
city: Koebenhavn OE
country: Denmark
facility: Rigshospitalet, Epidemiklinikken
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs
city: Orleans
country: France
facility: CHR d'Orleans la Source
state: Cedex 02
city: Paris
country: France
facility: Hopital Saint Antoine
state: Cedex 12
city: Paris
country: France
facility: Hopital Bichat
state: Cedex 18
city: Bordeaux cedex
country: France
facility: Hopital Saint-andre
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Le Kremlin Bicetre
country: France
facility: Hopital Bicetre
city: LYON Cedex 4
country: France
facility: Hopital de la Croix Rousse
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Paris Cedex 10
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Paris
country: France
facility: Hopital Tenon, Service des Maladies Infectieuses
city: Strasbourg Cedex
country: France
facility: Nouvel Hopital Civil
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Berlin
country: Germany
facility: Praxis Christiane Cordes
city: Berlin
country: Germany
facility: Studiengesellschaft mbH Gubener 37
city: Berlin
country: Germany
facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
city: Frankfurt am Main
country: Germany
facility: Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II
city: Frankfurt am Main
country: Germany
facility: InfektioResearch GmbH & Co. KG
city: Hamburg
country: Germany
facility: ifi - Studien und Projekte GmbH
city: Hamburg
country: Germany
facility: ICH - Study - Center GmbH & Co. KG
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Koeln
country: Germany
facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
city: Muenchen
country: Germany
facility: MUC Research Group GbR
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza
city: Warszawa
country: Poland
facility: SPZOZ Wojewodzki Szpital Zakazny
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca E.P.E.
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
city: Lisboa
country: Portugal
facility: Hospital Sta. Maria
city: Porto
country: Portugal
facility: Hospital São João
city: Bayamon
country: Puerto Rico
facility: Innovative Care PSC
city: Ponce
country: Puerto Rico
facility: Ararat Research Center
city: Rio Piedras
country: Puerto Rico
facility: Medical Center University Hospital
city: Rio Piedras
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research
city: L´hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia - Hospital Provincial
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Goteborg
country: Sweden
facility: SU Ostra sjukhuset, Infektionsmottagningen
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus
city: Stockholm
country: Sweden
facility: Sodersjukhuset, Venhalsan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Basel
country: Switzerland
facility: Universitaetsspital Basel Infektiologie und Spitalhygiene
city: Bern
country: Switzerland
facility: Inselspital Universitaetsklinik fuer Infektiologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Birmingham
country: United Kingdom
facility: Dept of Sexual Health & HIV Medicine
city: Brighton
country: United Kingdom
facility: HIV Research Department, Elton John Centre
city: Edinburgh
country: United Kingdom
facility: Regional Infectious Diseases Unit
city: London
country: United Kingdom
facility: Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,
city: London
country: United Kingdom
facility: Ian Charleson Day Centre, Royal Free Hospital
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Centre for Sexual Health & HIV Research, University College London
city: Manchester
country: United Kingdom
facility: Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: