Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
- Conditions
- HIV InfectionsHIV
- Interventions
- Registration Number
- NCT01095796
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/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-based STRs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 707
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stribild Stribild Stribild plus placebo to match Atripla Atripla Stribild Placebo Atripla plus placebo to match Stribild Stribild Atripla Placebo Stribild plus placebo to match Atripla Atripla Atripla Atripla plus placebo to match Stribild
- Primary Outcome Measures
Name Time Method 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 at Week 48 Week 48
- Secondary Outcome Measures
Name Time Method The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96 Week 96 The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192 Week 192 The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Week 48 The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144 Week 144 The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192 Baseline; Weeks 48, 96, 144, and 192 Change = value of the relevant time point minus the baseline value
The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm Week 48
Trial Locations
- Locations (102)
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Anthony Mills, MD, Inc.
🇺🇸Los Angeles, California, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Atlanta ID Group, PC
🇺🇸Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
Ruth M. Rothstein CORE Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Garden State Infectious Diseases Associates, PA
🇺🇸Voorhees, New Jersey, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Community Research Initiative
🇺🇸Boston, Massachusetts, United States
Research Access Network
🇺🇸Houston, Texas, United States
Therapeutic Concepts
🇺🇸Houston, Texas, United States
Gordon E. Crofoot MD PA
🇺🇸Houston, Texas, United States
Peter Shalit, MD
🇺🇸Seattle, Washington, United States
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
San Francisco General Hospital, University of California, San Francisco
🇺🇸San Francisco, California, United States
Metropolis Medical
🇺🇸San Francisco, California, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
🇺🇸San Francisco, California, United States
Leahi Hospital
🇺🇸Honolulu, Hawaii, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Apex Research, LLC
🇺🇸Denver, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
🇺🇸Tampa, Florida, United States
Infectious Disease Research Institute Inc.
🇺🇸Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Health for Life Clinic PLLC
🇺🇸Little Rock, Arkansas, United States
AHF Research Center
🇺🇸Beverly Hills, California, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
🇺🇸Los Angeles, California, United States
Kaiser Permanente Hospital
🇺🇸Hayward, California, United States
Living Hope Clinical Foundation
🇺🇸Long Beach, California, United States
UCLA Center for Clinical Aids Research and Education
🇺🇸Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States
Alameda County Medical Center
🇺🇸Oakland, California, United States
East Bay AIDS Center
🇺🇸Oakland, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Group
🇺🇸Sacramento, California, United States
Yale University HIV Clinical Trials Program
🇺🇸New Haven, Connecticut, United States
Capital Medical Associates, PC
🇺🇸Washington, District of Columbia, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Broward Health/Comprehensive Care Center
🇺🇸Fort Lauderdale, Florida, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Whitman-Walker Clinic
🇺🇸Washington, District of Columbia, United States
Gary J. Richmond, MD, PA
🇺🇸Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Idocf/ Valuhealthmd, Llc
🇺🇸Orlando, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
🇺🇸Miami Beach, Florida, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
Baystate Infectious Diseases Clinical Research
🇺🇸Springfield, Massachusetts, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Central West Clinical Research
🇺🇸St. Louis, Missouri, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Upstate ID Association
🇺🇸Albany, New York, United States
SouthWest CARE Center
🇺🇸Sante Fe, New Mexico, United States
Montefiore Medical Center - AIDS Center
🇺🇸Bronx, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
New York Hospital Queens
🇺🇸Flushing, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Greiger Clinic
🇺🇸Mount Vernon, New York, United States
Chelsea Village Medical, PC
🇺🇸New York, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Ricky K. Hsu, MD, PC
🇺🇸New York, New York, United States
The Aaron Diamond AIDS Research Center
🇺🇸New York, New York, United States
Clinical and Translational Research Center
🇺🇸Chapel Hill, North Carolina, United States
Carolinas Medical Center-Myers Park
🇺🇸Charlotte, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston Salem, North Carolina, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Tarrant County Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
Peabody Health Center
🇺🇸Dallas, Texas, United States
Valley AIDS Council
🇺🇸Harlingen, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
🇺🇸Annandale, Virginia, United States
Rockwood Pulmonary and Critical Care
🇺🇸Spokane, Washington, United States
Instituto de Investigacion Clentifica del Sur
🇵🇷Ponce, Puerto Rico
HOPE Clinical Research
🇵🇷San Juan, Puerto Rico
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
University of Puerto Rico, School of Medicine, Proyecto ACTU
🇵🇷San Juan, Puerto Rico
Summa Health System
🇺🇸Akron, Ohio, United States
Saint Michaels Medical Center
🇺🇸Newark, New Jersey, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Southampton Healthcare
🇺🇸St. Louis, Missouri, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States