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Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01108510
First received: April 20, 2010
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.


Condition Intervention Phase
HIV
HIV Infections
Drug: Cobicistat
Drug: Ritonavir
Drug: Atazanavir
Drug: FTC/TDF
Drug: Placebo to match COBI
Drug: Placebo to match RTV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot algorithm.


Secondary Outcome Measures:
  • Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The change from baseline in CD4 cell count at Week 48 was analyzed.


Enrollment: 698
Study Start Date: May 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATV/co+FTC/TDF
Participants will be randomized to receive COBI 150 mg, plus placebo to match RTV, plus ATV 300 mg, plus FTC 200 mg/TDF 300 mg once daily.
Drug: Cobicistat
Cobicistat (COBI) 150 mg tablet administered orally once daily
Other Names:
  • Tybost®
  • GS-9350
Drug: Atazanavir
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®
Drug: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Other Name: Truvada®
Drug: Placebo to match RTV
Placebo to match RTV administered orally once daily
Active Comparator: ATV/r+FTC/TDF
Participants will be randomized to receive RTV 100 mg, plus placebo to match COBI, plus ATV 300 mg, plus FTC 200 mg/TDF 300 mg once daily.
Drug: Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
Other Name: Norvir®
Drug: Atazanavir
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®
Drug: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Other Name: Truvada®
Drug: Placebo to match COBI
Placebo to match COBI administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to FTC, TDF and ATV
  • Normal ECG
  • Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 day s following the last dose of study drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new AIDS defining condition diagnosed within the 30 days prior to screening
  • Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Have an ECG PR interval ≥ 220 msec
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
  • Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
  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: NCT01108510

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, Arkansas
Health for Life Clinic PLLC
Little Rock, Arkansas, United States, 72207
United States, California
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Peter J Ruane, MD, Inc
Los Angeles, California, United States, 90036
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Kaiser Permanente
Los Angeles, California, United States, 90027
Oasis Clinic
Los Angeles, California, United States, 90059
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
University of California, Davis Medical Center
Sacramento, California, United States, 95817
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States, 94118
Metropolis Medical
San Francisco, California, United States, 94115
United States, Colorado
Apex Research, LLC
Denver, Colorado, United States, 80220
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
The Kinder Medical Group
Miami, Florida, United States, 33133
University of Miami School of Medicine
Miami, Florida, United States, 33136
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Idocf/ Valuhealthmd, Llc
Orlando, Florida, United States, 32806
Orlando Immunology Center
Orlando, Florida, United States, 32803
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33615
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida, United States, 33602
United States, Georgia
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Mercer University School of Medicine
Macon, Georgia, United States, 31210
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
CentralWest Clinical Research
St. Louis, Missouri, United States, 63108
United States, New Jersey
Saint Michaels Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New Mexico
SouthWest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Montefiore Medical Center - AIDS Center
Bronx, New York, United States, 10467
North Shore University Hospital
Manhasset, New York, United States, 11030
Chelsea Village Medical, PC
New York, New York, United States, 10011
Mt Sinai School of Medicine
New York, New York, United States, 10011
Ricky K. Hsu, MD, PC
New York, New York, United States, 10011
United States, North Carolina
Carolinas Medical Center-Myers Park
Charlotte, North Carolina, United States, 28207
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University, The Brody School of Medicine
Greenville, North Carolina, United States, 27834
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Division of Infectious Diseases, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75204
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Garcia's Family Health Group
Harlingen, Texas, United States, 78550
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Research Access Network
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Washington
Peter Shalit, M.D.
Seattle, Washington, United States, 98104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
Holdsworth House Medical practice
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Northside Clinic
Melbourne, Victoria, Australia, 3068
Austria
LKH Graz West
Graz, Austria, A-8010
Allgemeines Krankenhaus
Vienna, Austria, 1090
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, Austria, 1140
Belgium
Hôpital Universitaire Erasme - ULB
Brussels, Belgium, 1070
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
University of Ghent
Ghent, Belgium, 9000
Brazil
Instituto De Pesquisa Clinica Evandro Chagas
Rio de Janeiro, RJ, Brazil, 21040-900
URDIP Faculdade de Medicina do ABC
Santo Andre, Sao Paulo, Brazil, 09060-650
Universidade Estadual de Campinas
Campinas, Brazil, 13083-970
Instituto De Infectologia Emilo Ribas
São Paulo, Brazil, 01246-900
Crt-Dst/Aids
São Paulo, Brazil, 04121-000
Brasilmed Assistencia Medica E Pesquisas
São Paulo, Brazil, 01416-000
Canada, Manitoba
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, Canada, M5B1L6
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 4P9
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
Montréal, Quebec, Canada, H2X 2P4
Canada
Project LORI
Montreal, Canada, H3H 1V1
Denmark
Rigshospitalet, Infektionsklinik 5112
Copenhagen, Denmark, 2000
Dominican Republic
Instituto Dominicano de Estudios Virologicos - IDEV
Santo Domingo, Dominican Republic
France
Service des Maladies Infectieuses, CHU de Caen
Caen, France, 14033
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
Lyon, France, 69288
Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
Marseille, France, 13009
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, France, 44093
Bichat Hospital
Paris, France, 75018
Department of Infectious Diseases, Saint-Louis hospital
Paris, France, 75010
Hopital Saint Antoine, Service De Maladies Infectieuses
Paris, France, 75012
Maladies Infectieuses Dpt
Paris, France, 75651
Tenon Hospital, UPMC
Paris, France, 75020
Centre François Magendie, Hôpital du Haut Lévêque
Pessac, France, 33604
Centre Hospitalier de Tourcoing
Tourcoing, France, 59208
Germany
EPIMED GmbH
Berlin, Germany, 12157
Medizinische Universitätsklinik
Bonn, Germany, 53127
Infektio Research GmbH / Infektiologikum Frankfurt
Frankfurt am Main, Germany, 60311
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, Germany, 20246
ICH Study Center Hamburg
Hamburg, Germany, 20146
University of Cologne, Department of Internal Medicine
Koln, Germany, 50937
Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy, 20127
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
Milano, Italy, 20157
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Roma, Italy, 00149
Dipartimento di Malattie Infettive
Torino, Italy, 10149
Mexico
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Netherlands
Onze lieve vrouw gasthuis
Amsterdam, Netherlands, 1091 AC
Portugal
Hospital de Santa Maria - CHLN
Lisbon, Portugal, 1649-035
Serviço de Doenças Infecciosas, Hospital de São João
Porto, Portugal, 4202-451
Puerto Rico
Instituto de Investigacion Clentifica del Sur
Ponce, Puerto Rico, 00731
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Switzerland
CHUV
Lausanne, VD, Switzerland, 1011
Universitätsklinik für Infektiologie, Universitätsspital Bern
Bern, Switzerland, 3010
Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich
Zürich, Switzerland, 8091
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
Bangkok, Thailand, 10330
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
Chiang Mai, Thailand, 50200
Khon Kaen University
Khon Kaen, Thailand, 40002
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 1ES
Homerton University Hospital
London, United Kingdom, E9 6SR
Barts and the London NHS Trust
London, United Kingdom, E1 1BB
Courtyard Clinic, St. Georges Hospital
London, United Kingdom, SW17 0QT
Guys and St. Thomas' NHS Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01108510     History of Changes
Other Study ID Numbers: GS-US-216-0114
Study First Received: April 20, 2010
Results First Received: October 23, 2014
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Treatment Naive
HIV 1 Infected

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
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 27, 2014