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AzTrials

HIV-1Phase 3MODERNNCT01345630

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

A Phase 3 study testing Maraviroc, Emtricitabine/tenofovir and darunavir/ritonavir 800/100 mg in people with HIV-1, run by ViiV Healthcare at 177 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1
What is being tested?
Maraviroc, Emtricitabine/tenofovir and darunavir/ritonavir 800/100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
813 participants
Where
177 sitesin 19 countries
Study dates
Sep 2011to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 19 countries.

177 sites in 19 countries

United States84 sites

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30312

  • University of Colorado Denver - University of Colorado Hospital

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center, PC

    Berkley, Michigan, 48072

  • University of Alabama at Birmingham - 1917 Research Clinic

    Birmingham, Alabama, 35294

  • Erie County Medical Center

    Buffalo, New York, 14215

  • I.D. Consultants, P.A.

    Charlotte, North Carolina, 28209

  • Northwestern University/NMH

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of Cincinnati - Department of Internal Medicine

    Cincinnati, Ohio, 45267

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246

  • DeKalb Medical Diagnostic Breast Center

    Decatur, Georgia, 30033

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Kaiser Permanente of Colorado

    Denver, Colorado, 80205

  • University Physicians Group

    Detroit, Michigan, 48201

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

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

    East Lansing, Michigan, 48824

  • Biomedical and Health Institutional Review Board

    East Lansing, Michigan, 48825

  • Broward Health - Comprehensive Care Center

    Fort Lauderdale, Florida, 33311

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • (DEXA Scan Facility) East Carolina University Brody Outpatient Center

    Greenville, North Carolina, 27834

  • East Carolina University Division of Infectious Diseases

    Greenville, North Carolina, 27834

  • Kaiser Permanente

    Hayward, California, 94545

  • Health Services Center

    Hobson City, Alabama, 36201

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Research Access Network

    Houston, Texas, 77098

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

    Houston, Texas, 77098

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

    Iowa City, Iowa, 52242

  • Kansas City Free Health Clinic

    Kansas City, Missouri, 64111

  • Ingham County Health Department

    Lansing, Michigan, 48911

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Dr. Anthony Mills, MD, Inc.

    Los Angeles, California, 90069

  • The Kinder Medical Group

    Miami, Florida, 33133

  • UMHC/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami AIDS Clinical Research Unit

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • Community AIDS Resource Inc dba Care Resource

    Miami, Florida, 33137

  • Miami Research Associates

    Miami, Florida, 33143

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Brandywine Common

    Neptune City, New Jersey, 07754

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Yale - New Haven Hospital Nathan Smith Clinic

    New Haven, Connecticut, 06504

  • Yale University

    New Haven, Connecticut, 06510

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center - AIDS Clinical Trials Unit

    New York, New York, 10003

  • AIDS Community Research Initiative of America (ACRIA)

    New York, New York, 10018

  • Research Across America

    New York, New York, 10022

  • Dr. Howard A. Grossman, M.D.

    New York, New York, 10107

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Circle CARE Center

    Norwalk, Connecticut, 06851

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68106

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Infectious Diseases Associates of Northwest Florida, PA

    Pensacola, Florida, 32504

  • AIDS Care

    Rochester, New York, 14607

  • University of California Davis Research

    Sacramento, California, 95814

  • TICON I Research Clinic (DEXA Scan only)

    Sacramento, California, 95817

  • Kaiser Hospital Sacramento

    Sacramento, California, 95825

  • Synarc Inc.

    San Francisco, California, 94105

  • Investigational Drugs Pharmacy

    San Francisco, California, 94118

  • Kaiser Permanente - Clinical Trials Unit

    San Francisco, California, 94118

  • Kaiser Permanente Santa Clara

    Santa Clara, California, 95051

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • St. Joseph's Hospital Diagnostic Center

    Tampa, Florida, 33067

  • University of South Florida Health-HIV Clinical Research Unit

    Tampa, Florida, 33602

  • Infectious Disease Research Institute, Inc.

    Tampa, Florida, 33614

  • Osteoporosis Care Center

    Tampa, Florida, 33614

  • Quest Diagnostic Laboratory

    Tampa, Florida, 33614

  • The University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Kaiser Permanente

    Union City, California, 94587

  • New York Medical College

    Valhalla, New York, 10595

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Rowan Tree Medical, PA

    Wilton Manors, Florida, 33305

Other trials in United States

France14 sites

  • Hopital Saint-andre

    Bordeaux, France, 33075

  • Hopital Henri Mondor

    Créteil, 94000

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Hopital Gui de Chauliac

    Montpellier, 34295

  • CHU de Nantes - Hotel Dieu

    Nantes, 44035

  • CHR d'Orleans la Source

    Orléans, Cedex 02, 45067

  • Hopital Saint Antoine

    Paris, Cedex 12, 75571

  • Hopital Bichat

    Paris, Cedex 18, 75877

  • Hôpital de la Pitié Salpétrière

    Paris, 75013

  • Hopital Tenon, Service des Maladies Infectieuses

    Paris, 75020

  • Hopital Saint-Louis

    Paris, 75475

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Germany12 sites

  • Praxis Christiane Cordes

    Berlin, 10243

  • Studiengesellschaft mbH Gubener 37

    Berlin, 10243

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

    Berlin, 12157

  • Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

    Bonn, 53127

  • Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

    Cologne, 50937

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

    Frankfurt am Main, 60590

  • InfektioResearch GmbH & Co. KG

    Frankfurt am Main, 60596

  • ifi - Studien und Projekte GmbH

    Hamburg, 20099

  • ICH - Study - Center GmbH & Co. KG

    Hamburg, 20146

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • MUC Research Group GbR

    München, 80335

  • Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt

    München, 80336

Other trials in Germany

Spain9 sites

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario Reina Sofia - Hospital Provincial

    Córdoba, Cordoba, 14004

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital Universitario de La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Virgen de la Macarena

    Seville, Sevilla, 41007

Other trials in Spain

United Kingdom9 sites

  • Dept of Sexual Health & HIV Medicine

    Birmingham, B9 5SS

  • HIV Research Department, Elton John Centre

    Brighton, BN2 1ES

  • Regional Infectious Diseases Unit

    Edinburgh, EH4 2XU

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

    London, E1 1BB

  • Ian Charleson Day Centre, Royal Free Hospital

    London, NW3 2QG

  • Queen Elizabeth Hospital

    London, SE18 4QH

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

    London, SW10 9NH

  • Centre for Sexual Health & HIV Research, University College London

    London, WC1E 6AU

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

    Manchester, M8 5RB

Other trials in United Kingdom

Australia7 sites

  • Brisbane Sexual Health and HIV Service

    Brisbane, Queensland, 4000

  • Melbourne Sexual Health Centre

    Carlton, Victoria, 3053

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • Holdsworth House General Practice

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Clinical Research Unit, Infectious Diseases

    Melbourne, Victoria, 3004

  • Taylor Square Private Clinic

    Surry Hills, New South Wales, 2010

Other trials in Australia

Canada7 sites

  • Clinique Medicale L'Actuel

    Montreal, Quebec, H2L 4P9

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • The Ottawa Hospital-Riverside Campus

    Ottawa, Ontario, K1H 7W9

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Maple Leaf Research / Maple Leaf Medical Clinic

    Toronto, Ontario, M5G 1K2

  • University Health Network / Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Belgium6 sites

  • Instituut voor Tropische Geneeskunde

    Antwerp, B-2000

  • C.H.U. St-Pierre

    Brussels, 1000

  • Hôpital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • C.H.U. Sart-Tilman

    Liège, 4000

Other trials in Belgium

Puerto Rico6 sites

  • Innovative Care PSC

    Bayamón, PR, 00959

  • Ararat Research Center

    Ponce, PR, 00717

  • Medical Center University Hospital

    Rio Piedras, PR, 00935

  • University of Puerto Rico Medical Sciences Campus

    Rio Piedras, 00935

  • Clinical Research Puerto Rico

    San Juan, PR, 00909

  • HOPE Clinical Research

    San Juan, PR, 00909

Other trials in Puerto Rico

Portugal4 sites

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

    Amadora, Portugal, 2720-276

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

    Lisbon, 1169-050

  • Hospital Sta. Maria

    Lisbon, 1649-035

  • Hospital São João

    Porto, 4200-319

Other trials in Portugal

Sweden4 sites

  • SU Ostra sjukhuset, Infektionsmottagningen

    Gothenburg, 416 85

  • Skanes Universitetssjukhus

    Malmö, 205 02

  • Sodersjukhuset, Venhalsan

    Stockholm, 118 83

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

Other trials in Sweden

Switzerland4 sites

  • Universitaetsspital Basel Infektiologie und Spitalhygiene

    Basel, 4031

  • Inselspital Universitaetsklinik fuer Infektiologie

    Bern, 3010

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Denmark3 sites

  • Hvidovre Hospital, Infektionsmedicinsk afd.

    Hvidovre, 2650

  • Rigshospitalet, Epidemiklinikken

    Koebenhavn OE, 2100

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Poland3 sites

  • Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza

    Bydgoszcz, 85-030

  • SPZOZ Wojewodzki Szpital Zakazny

    Warsaw, 01-201

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

    Wroclaw, 50-220

Other trials in Poland

Austria1 site

  • AKH Wien Universitaetsklinik fuer Dermatologie

    Vienna, 1090

Other trials in Austria

Finland1 site

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

    Helsinki, 00250

Other trials in Finland

Hungary1 site

  • Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

    Budapest, 1097

Other trials in Hungary

Italy1 site

  • Ospedale San Raffaele

    Milan, 20127

Other trials in Italy

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

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

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.

Read the 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).

Conditions
HIV-1
Being tested
Maraviroc, Emtricitabine/tenofovir, darunavir/ritonavir 800/100 mg, placebo for emtricitabine/tenofovir, placebo for maraviroc
Keywords
Double-blind, comparative, trial, maraviroc, versus, emtricitabine/tenofovir, both with darunavir/ritonavir, antiretroviral-naive, Ccr5 tropic, Hiv 1, patients.
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaravirocDrug

    Also called Selzentry, Celsentri

    Maraviroc tablet 150 mg once daily for 96 weeks.

  • Emtricitabine/tenofovirDrug

    Also called Truvada

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

  • darunavir/ritonavir 800/100 mgDrug

    darunavir/ritonavir 800/100 mg

  • placebo for emtricitabine/tenofovirDrug

    Also called Truvada

    placebo for emtricitabine/tenofovir

  • placebo for maravirocDrug

    Also called Selzentry, Celsentri

    placebo for maraviroc

Study groups in NCT01345630
Study groupRoleWhat they receive
MaravirocExperimentalMaraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Receives: Drug: Maraviroc; Drug: darunavir/ritonavir 800/100 mg; Drug: placebo for maraviroc
Emtricitabine/tenofovirActive comparatorEmtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Receives: Drug: Emtricitabine/tenofovir; Drug: placebo for emtricitabine/tenofovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (24)

  1. Frequency of Adverse Events (AE).

    Number of participants with treatment-emergent non serious AEs

    Measured: Week 96

  2. Number of Participants With Grade 3 or 4 AEs

    Number of participants with grade 3 or 4 AEs are presented here.

    Measured: Week 96

  3. 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.

    Measured: Week 96

  4. Number of Treatment-related AEs

    Number of treatment-related AEs are presented here.

    Measured: Week 96

  5. Number of Participants With Treatment-emergent Serious Adverse Events

    Total number of participants with treatment-emergent serious adverse events are reported

    Measured: Week 96

  6. Number of Participants With Abnormal Laboratory Values

    Number of participants with laboratory abnormalities are reported

    Measured: Week 96

  7. 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.

    Measured: Week 96

  8. 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.

    Measured: Week 48

  9. 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).

    Measured: Week 48

  10. 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.

    Measured: Week 48

  11. 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.

    Measured: Week 48

  12. 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.

    Measured: Week 48

  13. 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.

    Measured: Baseline, Week 48

  14. 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.

    Measured: Baseline, Week 48

  15. 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.

    Measured: Baseline, Week 48

  16. 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.

    Measured: Baseline, Week 48

  17. 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.

    Measured: Baseline, Week 48

  18. 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.

    Measured: Week 48

  19. 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.

    Measured: Week 48

  20. 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.

    Measured: Week 48

  21. 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.

    Measured: Week 48

  22. 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.

    Measured: Week 48

  23. 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.

    Measured: Week 48

  24. 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.

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionAug 2013
  4. Study completionJan 2014

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
813 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345630
Sponsor's protocol ID
A4001095
Other IDs
2010-021785-30
Acronym
MODERN
Status last verified
Dec 2015
First submitted
27 Apr 2011
Last updated
14 Jan 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maraviroc, Emtricitabine/tenofovir and darunavir/ritonavir 800/100 mg in people with HIV-1, run by ViiV Healthcare at 177 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, France, Germany, Spain, United Kingdom and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL. (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01345630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.

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