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
- Conditions
- HIVHIV Infections
- Interventions
- Drug: ATVDrug: ATV PlaceboDrug: FTC/TDFDrug: FTC/TDF Placebo
- Registration Number
- NCT01106586
- 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 ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
- 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
- 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, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stribild Stribild - Stribild RTV Placebo - Stribild FTC/TDF Placebo - ATV/r + FTC/TDF ATV - Stribild ATV Placebo - ATV/r + FTC/TDF FTC/TDF - ATV/r + FTC/TDF Stribild Placebo - ATV/r + FTC/TDF Ritonavir -
- 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 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 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 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 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
Trial Locations
- Locations (146)
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Ruth M. Rothstein CORE Center
🇺🇸Chicago, Illinois, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Wake Forest University Health Sciences
🇺🇸Winston Salem, North Carolina, United States
University of Ghent
🇧🇪Ghent, Belgium
Northside Clinic
🇦🇺Melbourne, Victoria, Australia
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
CHUV
🇨🇭Lausanne, VD, Switzerland
CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
Hôpital Universitaire Erasme - ULB
🇧🇪Brussels, Belgium
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
North Manchester General Hospital
🇬🇧Manchester, Lancashire, United Kingdom
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Onze lieve vrouw gasthuis
🇳🇱Amsterdam, Netherlands
Serviço de Doenças Infecciosas, Hospital de São João
🇵🇹Porto, Portugal
Ramathibodi Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, East Sussex, United Kingdom
Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)
🇺🇸Houston, Texas, United States
Research Access Network
🇺🇸Houston, Texas, United States
Peter Shalit, M.D.
🇺🇸Seattle, Washington, United States
Apex Research, LLC
🇺🇸Denver, California, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Anthony Mills MD Inc
🇺🇸Los Angeles, California, United States
Yale University HIV Clinical Trials Program
🇺🇸New Haven, Connecticut, United States
Peter J Ruane, MD, Inc
🇺🇸Los Angeles, California, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
🇺🇸Los Angeles, California, United States
AHF Research Center
🇺🇸Beverly Hills, California, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Kaiser Permanente Medical Group
🇺🇸Sacramento, California, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
Division of Infectious Diseases, St. Louis University Medical Center
🇺🇸St. Louis, Missouri, United States
LKH Graz West
🇦🇹Graz, Austria
Southampton Healthcare
🇺🇸St. Louis, Missouri, United States
Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
🇺🇸Annandale, Virginia, United States
Clinique medicale l'Actuel
🇨🇦Montreal, Quebec, Canada
Summa Health System
🇺🇸Akron, Ohio, United States
Centre Hospitalier Universitaire de Nice
🇫🇷Nice, France
Tarrant County Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
Taylor Square Private Clinica
🇦🇺Darlinghurst, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
East Sydney Doctors
🇦🇺Sydney, New South Wales, Australia
Chelsea Village Medical, PC
🇺🇸New York, New York, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
CHU Gui de Chauliac, Maladies Infectieuses Dpt
🇫🇷Montpellier, France
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Holdsworth House Medical practice
🇦🇺Darlinghurst, New South Wales, Australia
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Epidemiklinikken 5112, Rigshospitalet
🇩🇰Copenhagen, Denmark
Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna
🇦🇹Vienna, Austria
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
🇦🇹Vienna, Austria
Centre Hospitalier de Tourcoing
🇫🇷Tourcoing, France
Department of Infectious Diseases, Saint-Louis hospital
🇫🇷Paris, France
Bichat Hospital
🇫🇷Paris, France
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
🇨🇦Toronto, Ontario, Canada
MUC Research GmbH
🇩🇪München, Germany
University Health Network, Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Southern Alberta Clinic
🇨🇦Calgary, Alberta, Canada
University of Cologne, Department of Internal Medicine
🇩🇪Köln, Germany
Hopital Saint Antoine, Service De Maladies Infectieuses
🇫🇷Paris, France
St. Mary's Hospital, London (Imperial College, London)
🇬🇧London, United Kingdom
Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68
🇩🇪Frankfurt am Main, Germany
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
🇮🇹Rome, Italy
CHU de Nantes Hopital de l'Hotel Dieu
🇫🇷Nantes, France
University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
🇩🇪Bonn, Germany
Infektio Research GmbH / Infektiologikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
🇫🇷Lyon, France
Center for HIV and Hepatogastroenterology
🇩🇪Duesseldorf, Germany
Barts and the London NHS Trust
🇬🇧London, United Kingdom
Chelsea and Westminster Hospital Foundation Trust
🇬🇧London, United Kingdom
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
🇩🇪Hamburg, Germany
Dipartimento di Malattie Infettive
🇮🇹Torino, Italy
Venhälsan, Södersjukhuset
🇸🇪Stockholm, Sweden
Homerton University Hospital
🇬🇧London, United Kingdom
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Metropolitan Medical
🇺🇸San Francisco, California, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Leahi Hospital
🇺🇸Honolulu, Hawaii, United States
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
🇺🇸Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
Alameda County Medical Center
🇺🇸Oakland, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Wohlfeiler, Piperato and Associates, LLC
🇺🇸Miami Beach, Florida, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
IDOCF/ ValueHealthMD, LLC
🇺🇸Orlando, Florida, United States
Infectious Disease Research Institute Inc.
🇺🇸Tampa, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Montiefiore Medical Center- AIDS Center
🇺🇸Bronx, New York, United States
Upstate ID Association
🇺🇸Albany, New York, United States
AIDS Care
🇺🇸Rochester, New York, United States
Division of Infectious Diseases, Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Carolinas Medical Center-Myers Park
🇺🇸Charlotte, North Carolina, United States
Health for Life Clinic PLLC
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Hospital
🇺🇸Hayward, California, United States
CSI Clinical Trials, Inc.
🇺🇸Costa Mesa, California, United States
Living Hope Clinical Foundation
🇺🇸Long Beach, California, United States
East Bay AIDS Center
🇺🇸Oakland, California, United States
Capital Medical Associates, PC
🇺🇸Washington, District of Columbia, United States
Gary J. Richmond,M.D., P.A.
🇺🇸Fort Lauderdale, Florida, United States
Broward Health/Comprehensive Care Center
🇺🇸Fort Lauderdale, Florida, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Baystate Infectious Diseases Clinical Research
🇺🇸Springfield, Massachusetts, United States
Infectious Disease Solutions, PC
🇺🇸Atlanta, Georgia, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
CentralWest Clinical Research
🇺🇸St. Louis, Missouri, United States
Saint Michaels Medical Center
🇺🇸Newark, New Jersey, United States
Garden State Infectious Diseases Associates, PA
🇺🇸Voorhees, New Jersey, United States
Greiger Clinic
🇺🇸Mount Vernon, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)
🇺🇸Dallas, Texas, United States
Gordon E. Crofoot MD PA
🇺🇸Houston, Texas, United States
Garcia's Family Health Group
🇺🇸Harlingen, Texas, United States
Albion Street Centre
🇦🇺Sydney, New South Wales, Australia
National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales
🇦🇺Darlinghurst, New South Wales, Australia
Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)
🇦🇺Carlton, Victoria, Australia
Service des Maladies Infectieuses, CHU de Caen
🇫🇷Caen, France
Tenon Hospital, UPMC
🇫🇷Paris, France
ICH Study Center Hamburg
🇩🇪Hamburg, Germany
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milan, Italy
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Erasmus MC, Internal Medicine, Section of Infectious Diseases
🇳🇱Rotterdam, Netherlands
STAR Health Care Center (SUNY Downstate)
🇺🇸Brooklyn, New York, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
🇺🇸Dallas, Texas, United States
Albany Medical College
🇺🇸Albany, New York, United States