Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla 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:
NCT01095796
First received: March 17, 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 efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.


Condition Intervention Phase
HIV
HIV Infections
Drug: Stribild
Drug: Atripla
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 Efavirenz/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: 700
Study Start Date: March 2010
Estimated Study Completion Date: April 2014
Primary Completion Date: July 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 once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)
Active Comparator: Atripla Drug: Atripla
Atripla (efavirenz [EFV] 150 mg/FTC 200mg/TDF 300 mg) STR QHS + 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
  • 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 EFV
  • 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 12 weeks 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
  • 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, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla 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: NCT01095796

  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
AHF Research Center
Beverly Hills, California, United States, 90211
Kaiser Permanente Hospital
Hayward, California, United States, 94545
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
UCLA Center for Clinical Aids Research and Education
Los Angeles, California, United States, 90035
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
Kaiser Permanente
Los Angeles, California, United States, 90027
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
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
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Metropolis Medical
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States, 94118
San Francisco General Hospital, University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Apex Research, LLC
Denver, Colorado, United States, 80209
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
Whitman-Walker Clinic
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
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
United States, Florida
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Gary J. Richmond, MD, PA
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
University of Miami School of Medicine
Miami, Florida, United States, 33136
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/ Valuhealthmd, 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
Emory University
Atlanta, Georgia, United States, 30308
Atlanta ID Group, PC
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
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, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Community Research Initiative
Boston, Massachusetts, United States, 02215
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
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
Central West Clinical Research
St. Louis, Missouri, United States, 63108
Southampton Healthcare
St. Louis, Missouri, United States, 63139
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 Mexico
SouthWest CARE Center
Sante Fe, New Mexico, United States, 87505
United States, New York
Upstate ID Association
Albany, New York, United States, 12208
Montefiore Medical Center - AIDS Center
Bronx, New York, United States, 10467
Jacobi Medical Center
Bronx, New York, United States, 31210
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
New York Hospital Queens
Flushing, New York, United States, 11355
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
Ricky K. Hsu, MD, PC
New York, New York, United States, 10011
The Aaron Diamond AIDS Research Center
New York, New York, United States, 10016
Beth Israel Medical Center
New York, New York, United States, 10003
United States, North Carolina
Clinical and Translational Research Center
Chapel Hill, North Carolina, United States, 27599
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
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
Peabody Health Center
Dallas, Texas, United States, 75215
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Valley AIDS Council
Harlingen, Texas, United States, 78550
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Therapeutic Concepts
Houston, Texas, United States, 77004
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, MD
Seattle, Washington, United States, 98104
Rockwood Pulmonary and Critical Care
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
Instituto de Investigacion Clentifica del Sur
Ponce, Puerto Rico, 00731
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
University of Puerto Rico, School of Medicine, Proyecto ACTU
San Juan, Puerto Rico, 00935
HOPE Clinical Research
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Martin Rhee, MD Gilead Sciences
  More Information

Publications:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01095796     History of Changes
Other Study ID Numbers: GS-US-236-0102
Study First Received: March 17, 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:
Treatment Naive
HIV 1 Infected

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
Tenofovir disoproxil
Tenofovir
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014