Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01106586
First received: April 14, 2010
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

To evaluate the safety and efficacy of Stribild, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada). Ritonavir-boosted atazanavir + Truvada was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.


Condition Intervention Phase
HIV
HIV Infections
Drug: Stribild
Drug: ATV/r + Truvada
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 Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with virologic success assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.


Secondary Outcome Measures:
  • The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL using the FDA-defined TLOVR algorithm was summarized.

  • The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Change = Week 48 value minus baseline value.

  • The Percentage of Participants With HIV-1 RNA < 50 Copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with plasma HIV-1 RNA < 50 copies/mL was summarized.


Enrollment: 708
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stribild Drug: Stribild
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR + placebos to match ritonavir-boosted atazanavir (ATV/r) and Truvada once daily (QD)
Active Comparator: ATV/r + Truvada Drug: ATV/r + Truvada
Atazanavir 300 mg/Ritonavir 100 mg (ATV/r) and FTC 200 mg/TDF 300 mg (Truvada) + placebo to match Stribild STR QD

  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 electrocardiogram (ECG)
  • Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
  • Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 x the upper limit of the normal range (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 days following the last dose of study drug
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new acquired immunodeficiency syndrome (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)
  • 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
  • History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive 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 EVG, COBI, FTC, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir tablets
  • Participation in any other clinical trial without prior approval
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106586

  Hide Study Locations
Locations
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
AHF Research Center
Beverly Hills, California, United States, 90211
CSI Clinical Trials, Inc.
Costa Mesa, California, United States, 92626
Apex Research, LLC
Denver, California, United States, 80209
Kaiser Permanente Hospital
Hayward, California, United States, 94545
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J Ruane, MD, Inc
Los Angeles, California, United States, 90036
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
Kaiser Permanente
Los Angeles, California, United States, 90027
Orange Coast Medical Group
Newport Beach, California, United States, 92663
Alameda County Medical Center
Oakland, California, United States, 94602
East Bay AIDS Center
Oakland, California, United States, 94609
Stanford University
Palo Alto, California, United States, 94303
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
Metropolitan Medical
San Francisco, California, United States, 94115
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Connecticut
Yale University HIV Clinical Trials Program
New Haven, Connecticut, United States, 06033
The Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
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
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond,M.D., P.A.
Fort Lauderdale, Florida, United States, 33316
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33311
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
The Kinder Medical Group
Miami, Florida, United States, 33133
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ ValueHealthMD, LLC
Orlando, Florida, United States, 32806
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
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Infectious Disease Solutions, PC
Atlanta, Georgia, United States, 30309
Mercer University School of Medicine
Macon, Georgia, United States, 31210
United States, Hawaii
Leahi Hospital
Honolulu, Hawaii, United States, 96816
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
The Research Institute
Springfield, Massachusetts, United States, 01107
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
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
Southampton Healthcare
St. Louis, Missouri, United States, 63139
Division of Infectious Diseases, St. Louis University Medical Center
St. Louis, Missouri, United States, 63110
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States, 08844
Saint Michaels Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
Garden State Infectious Diseases Associates, PA
Voorhees, New Jersey, United States, 08043
United States, New York
Albany Medical College
Albany, New York, United States, 12209
Upstate ID Association
Albany, New York, United States, 12208
Montiefiore Medical Center- AIDS Center
Bronx, New York, United States, 10467
STAR Health Care Center (SUNY Downstate)
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
Greiger Clinic
Mount Vernon, New York, United States, 10550
Chelsea Village Medical, PC
New York, New York, United States, 10011
Beth Israel Medical Center
New York, New York, United States, 10003
AIDS Care
Rochester, New York, United States, 14604
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
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, Ohio
Summa Health System
Akron, Ohio, United States, 44304
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Division of Infectious Diseases, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)
Dallas, Texas, United States, 75204
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States, 75208
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Garcia's Family Health Group
Harlingen, Texas, United States, 78550
Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)
Houston, Texas, United States, 77004
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Research Access Network
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, M.D.
Seattle, Washington, United States, 98104
Australia, New South Wales
National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales
Darlinghurst, New South Wales, Australia, 2010
Holdsworth House Medical practice
Darlinghurst, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
East Sydney Doctors
Sydney, New South Wales, Australia, 2010
Australia, Victoria
Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)
Carlton, Victoria, Australia, 3053
Northside Clinic
Melbourne, Victoria, Australia, 3068
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia
Taylor Square Private Clinica
Darlinghurst, Australia, N.S.W. 2011
Austria
LKH Graz West
Graz, Austria, A-8010
Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna
Vienna, Austria, 1090
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, Austria, 1140
Belgium
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
Hôpital Universitaire Erasme - ULB
Brussels, Belgium, 1070
University of Ghent
Ghent, Belgium, 9000
Canada, Alberta
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R0X7
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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 4P9
Denmark
Epidemiklinikken 5112, Rigshospitalet
Copenhagen, Denmark, 2000
France
Service des Maladies Infectieuses, CHU de Caen
Caen, France, 14033
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
Lyon, France, 69317
CHU Gui de Chauliac, Maladies Infectieuses Dpt
Montpellier, France, 34295
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, France, 44093
Centre Hospitalier Universitaire de Nice
Nice, France, 06200
Hopital Saint Antoine, Service De Maladies Infectieuses
Paris, France, 75012
Hopital Pitie-Salpetriere
Paris, France, 75651
Department of Infectious Diseases, Saint-Louis hospital
Paris, France, 75010
Tenon Hospital, UPMC
Paris, France, 75020
Bichat Hospital
Paris, France, 75018
Centre Hospitalier de Tourcoing
Tourcoing, France, 59208
Germany
University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
Bonn, Germany, 53127
Center for HIV and Hepatogastroenterology
Duesseldorf, Germany, 40237
Infektio Research GmbH / Infektiologikum Frankfurt
Frankfurt am Main, Germany, 60311
Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
Frankfurt am Main, Germany, 60590
ICH Study Center Hamburg
Hamburg, Germany, 20146
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
Hamburg, Germany, 20246
University of Cologne, Department of Internal Medicine
Köln, Germany, 50937
MUC Research GmbH
München, Germany, 80335
Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy, 20127
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
Rome, 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
Erasmus MC, Internal Medicine, Section of Infectious Diseases
Rotterdam, Netherlands, 3000 CA
Portugal
Serviço de Doenças Infecciosas, Hospital de São João
Porto, Portugal, 4202-451
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
Sweden
Venhälsan, Södersjukhuset
Stockholm, Sweden, 11883
Switzerland
CHUV
Lausanne, VD, Switzerland, 1011
Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Siriraj Hospital
Bangkok, Thailand, 10700
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 1ES
North Manchester General Hospital
Manchester, Lancashire, United Kingdom, M8 5RB
St. Mary's Hospital, London (Imperial College, London)
London, United Kingdom, W2 1NY
Barts and the London NHS Trust
London, United Kingdom, E1 1BB
Chelsea and Westminster Hospital Foundation Trust
London, United Kingdom, SW10 9NH
Homerton University Hospital
London, United Kingdom, E9 6SR
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Marshall Fordyce, MD Gilead Sciences
  More Information

Publications:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01106586     History of Changes
Other Study ID Numbers: GS-US-236-0103
Study First Received: April 14, 2010
Results First Received: September 20, 2012
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV 1 Infection
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir
Tenofovir disoproxil
Tenofovir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014