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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01345630
Other study ID # A4001095
Secondary ID 2010-021785-30
Status Terminated
Phase Phase 3
First received April 27, 2011
Last updated December 11, 2015
Start date September 2011
Est. completion date January 2014

Study information

Verified date December 2015
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 813
Est. completion date January 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.
Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
darunavir/ritonavir 800/100 mg
darunavir/ritonavir 800/100 mg
placebo for emtricitabine/tenofovir
placebo for emtricitabine/tenofovir
placebo for maraviroc
placebo for maraviroc

Locations

Country Name City State
Australia Brisbane Sexual Health and HIV Service Brisbane Queensland
Australia Melbourne Sexual Health Centre Carlton Victoria
Australia East Sydney Doctors Darlinghurst New South Wales
Australia Holdsworth House General Practice Darlinghurst New South Wales
Australia St Vincent's Hospital Darlinghurst New South Wales
Australia Clinical Research Unit, Infectious Diseases Melbourne Victoria
Australia Taylor Square Private Clinic Surry Hills New South Wales
Austria AKH Wien Universitaetsklinik fuer Dermatologie Wien
Belgium Instituut voor Tropische Geneeskunde Antwerpen
Belgium C.H.U. St-Pierre Brussels
Belgium Cliniques Universitaires St-Luc Brussels
Belgium Hôpital Universitaire Erasme Bruxelles
Belgium Universitair Ziekenhuis Gent Gent
Belgium C.H.U. Sart-Tilman Liege
Canada Clinique Medicale du Quartier Latin Montreal Quebec
Canada Clinique Medicale L'Actuel Montreal Quebec
Canada The Ottawa Hospital Ottawa Ontario
Canada The Ottawa Hospital-Riverside Campus Ottawa Ontario
Canada Maple Leaf Research / Maple Leaf Medical Clinic Toronto Ontario
Canada University Health Network / Toronto General Hospital Toronto Ontario
Canada Vancouver ID Research and Care Centre Society Vancouver British Columbia
Denmark Hvidovre Hospital, Infektionsmedicinsk afd. Hvidovre
Denmark Rigshospitalet, Epidemiklinikken Koebenhavn OE
Denmark Odense Universitetshospital Odense
Finland Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs Helsinki
France Hopital Saint-andre Bordeaux cedex
France Hopital Henri Mondor Creteil
France Hopital Bicetre Le Kremlin Bicetre
France Hopital de la Croix Rousse LYON Cedex 4
France Hopital Gui de Chauliac Montpellier
France CHU de Nantes - Hotel Dieu Nantes
France CHR d'Orleans la Source Orleans Cedex 02
France Hopital Bichat Paris Cedex 18
France Hôpital de la Pitié Salpétrière Paris
France Hopital Saint Antoine Paris Cedex 12
France Hopital Tenon, Service des Maladies Infectieuses Paris
France Hopital Saint-Louis Paris Cedex 10
France Nouvel Hopital Civil Strasbourg Cedex
France Centre Hospitalier de Tourcoing Tourcoing
Germany EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin
Germany Praxis Christiane Cordes Berlin
Germany Studiengesellschaft mbH Gubener 37 Berlin
Germany Universitaetsklinikum Bonn, Immunologische Ambulanz HIV Bonn
Germany InfektioResearch GmbH & Co. KG Frankfurt am Main
Germany Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II Frankfurt am Main
Germany ICH - Study - Center GmbH & Co. KG Hamburg
Germany ifi - Studien und Projekte GmbH Hamburg
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin Koeln
Germany Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt Muenchen
Germany MUC Research Group GbR Muenchen
Hungary Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet Budapest
Italy Ospedale San Raffaele Milano
Netherlands University Medical Center Utrecht Utrecht
Poland Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza Bydgoszcz
Poland SPZOZ Wojewodzki Szpital Zakazny Warszawa
Poland EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej Wroclaw
Portugal Hospital Prof. Doutor Fernando Fonseca E.P.E. Amadora
Portugal Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos Lisboa
Portugal Hospital Sta. Maria Lisboa
Portugal Hospital São João Porto
Puerto Rico Innovative Care PSC Bayamon
Puerto Rico Ararat Research Center Ponce
Puerto Rico Medical Center University Hospital Rio Piedras
Puerto Rico University of Puerto Rico Medical Sciences Campus Rio Piedras
Puerto Rico Clinical Research Puerto Rico San Juan
Puerto Rico HOPE Clinical Research San Juan
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Clinic I Provincial de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Reina Sofia - Hospital Provincial Cordoba
Spain Hospital Universitari de Bellvitge L´hospitalet de Llobregat Barcelona
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario de La Paz Madrid
Spain Hospital Universitario Virgen de la Macarena Sevilla
Sweden SU Ostra sjukhuset, Infektionsmottagningen Goteborg
Sweden Skanes Universitetssjukhus Malmo
Sweden Karolinska Universitetssjukhuset Huddinge Stockholm
Sweden Sodersjukhuset, Venhalsan Stockholm
Switzerland Universitaetsspital Basel Infektiologie und Spitalhygiene Basel
Switzerland Inselspital Universitaetsklinik fuer Infektiologie Bern
Switzerland Kantonsspital St. Gallen St. Gallen
Switzerland Universitatsspital Zurich Zurich
United Kingdom Dept of Sexual Health & HIV Medicine Birmingham
United Kingdom HIV Research Department, Elton John Centre Brighton
United Kingdom Regional Infectious Diseases Unit Edinburgh
United Kingdom Centre for Sexual Health & HIV Research, University College London London
United Kingdom Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, London
United Kingdom Ian Charleson Day Centre, Royal Free Hospital London
United Kingdom Queen Elizabeth Hospital London
United Kingdom St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust London
United Kingdom Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals Manchester
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States University of Colorado Denver - University of Colorado Hospital Aurora Colorado
United States Central Texas Clinical Research Austin Texas
United States Be Well Medical Center, PC Berkley Michigan
United States University of Alabama at Birmingham - 1917 Research Clinic Birmingham Alabama
United States Erie County Medical Center Buffalo New York
United States I.D. Consultants, P.A. Charlotte North Carolina
United States Howard Brown Health Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Northwestern University/NMH Chicago Illinois
United States University of Cincinnati - Department of Internal Medicine Cincinnati Ohio
United States Dallas Diabetes and Endocrine Center Dallas Texas
United States North Texas Infectious Diseases Consultants, PA Dallas Texas
United States Parkland Memorial Hospital Dallas Texas
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States DeKalb Medical Diagnostic Breast Center Decatur Georgia
United States Infectious Disease Specialists of Atlanta Decatur Georgia
United States Kaiser Permanente of Colorado Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States University Physicians Group Detroit Michigan
United States Wayne State University Detroit Michigan
United States Biomedical and Health Institutional Review Board East Lansing Michigan
United States Michigan State University College of Osteopathic Medicine - Department of Internal Medicine East Lansing Michigan
United States Broward General Medical Center Fort Lauderdale Florida
United States Broward Health - Comprehensive Care Center Fort Lauderdale Florida
United States (DEXA Scan Facility) East Carolina University Brody Outpatient Center Greenville North Carolina
United States East Carolina University Division of Infectious Diseases Greenville North Carolina
United States Kaiser Permanente Hayward California
United States Health Services Center Hobson City Alabama
United States Research Access Network Houston Texas
United States The Office of Dr. Gordon E. Crofoot, M.D., PA Houston Texas
United States Therapeutic Concepts, PA Houston Texas
United States University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease Iowa City Iowa
United States Kansas City Free Health Clinic Kansas City Missouri
United States Ingham County Health Department Lansing Michigan
United States Cedars-Sinai Medical Center Los Angeles California
United States Dr. Anthony Mills, MD, Inc. Los Angeles California
United States Community AIDS Resource Inc dba Care Resource Miami Florida
United States Miami Research Associates Miami Florida
United States The Kinder Medical Group Miami Florida
United States UMHC/Sylvester Comprehensive Cancer Center Miami Florida
United States University of Miami Miami Florida
United States University of Miami AIDS Clinical Research Unit Miami Florida
United States Wohlfeiler, Piperato and Associates, LLC Miami Beach Florida
United States Hennepin County Medical Center Minneapolis Minnesota
United States Brandywine Common Neptune New Jersey
United States Jersey Shore University Medical Center Neptune New Jersey
United States Jersey Shore University Medical Center Neptune New Jersey
United States Yale - New Haven Hospital Nathan Smith Clinic New Haven Connecticut
United States Yale University New Haven Connecticut
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States AIDS Community Research Initiative of America (ACRIA) New York New York
United States Beth Israel Medical Center - AIDS Clinical Trials Unit New York New York
United States Dr. Howard A. Grossman, M.D. New York New York
United States Research Across America New York New York
United States Saint Michael's Medical Center Newark New Jersey
United States Orange Coast Medical Group Newport Beach California
United States Circle CARE Center Norwalk Connecticut
United States University of Nebraska Medical Center Omaha Nebraska
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Infectious Diseases Associates of Northwest Florida, PA Pensacola Florida
United States AIDS Care Rochester New York
United States Kaiser Hospital Sacramento Sacramento California
United States TICON I Research Clinic (DEXA Scan only) Sacramento California
United States University of California Davis Research Sacramento California
United States Investigational Drugs Pharmacy San Francisco California
United States Kaiser Permanente - Clinical Trials Unit San Francisco California
United States Synarc Inc. San Francisco California
United States Kaiser Permanente Santa Clara Santa Clara California
United States Swedish Medical Center Seattle Washington
United States Swedish Medical Center Seattle Washington
United States Baystate Infectious Diseases Clinical Research Springfield Massachusetts
United States Infectious Disease Research Institute, Inc. Tampa Florida
United States Osteoporosis Care Center Tampa Florida
United States Quest Diagnostic Laboratory Tampa Florida
United States St. Joseph's Hospital Diagnostic Center Tampa Florida
United States University of South Florida Health-HIV Clinical Research Unit Tampa Florida
United States The University of Toledo Medical Center Toledo Ohio
United States Kaiser Permanente Union City California
United States New York Medical College Valhalla New York
United States Capital Medical Associates, PC Washington District of Columbia
United States George Washington University Medical Faculty Associates Washington District of Columbia
United States Rowan Tree Medical, PA Wilton Manors Florida

Sponsors (2)

Lead Sponsor Collaborator
ViiV Healthcare Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Frequency of Adverse Events (AE). Number of participants with treatment-emergent non serious AEs Week 96 Yes
Secondary Number of Participants With Grade 3 or 4 AEs Number of participants with grade 3 or 4 AEs are presented here. Week 96 Yes
Secondary Number of Participants Who Discontinued Due to AEs Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants. Week 96 Yes
Secondary Number of Treatment-related AEs Number of treatment-related AEs are presented here. Week 96 Yes
Secondary Number of Participants With Treatment-emergent Serious Adverse Events Total number of participants with treatment-emergent serious adverse events are reported Week 96 Yes
Secondary Number of Participants With Abnormal Laboratory Values Number of participants with laboratory abnormalities are reported Week 96 Yes
Secondary Severity of Abnormal Laboratory Values Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant. Week 96 Yes
Secondary 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). The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. =100,000) copies/mL via the Mantel Haenszel (MH) method. Week 48 No
Secondary Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF). Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA =50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA =50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA =2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA =2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012). Week 48 No
Secondary Tropism Change Between Screening or Baseline and PDTF For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF. Week 48 No
Secondary Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria. For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism. Week 48 No
Secondary 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 For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm. Week 48 No
Secondary Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3) The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared. Baseline, Week 48 No
Secondary Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%) The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. Baseline, Week 48 No
Secondary Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3) The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. Baseline, Week 48 No
Secondary Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%) The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. Baseline, Week 48 No
Secondary Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48 The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared. Baseline, Week 48 No
Secondary Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48. A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. Week 48 Yes
Secondary Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48 A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. Week 48 Yes
Secondary Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan. Week 48 Yes
Secondary Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan. Week 48 Yes
Secondary Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan. Week 48 Yes
Secondary Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study. Week 48 Yes
Secondary Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1) Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study. Week 48 Yes
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