Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
- Conditions
- HIVHIV Infections
- Interventions
- Registration Number
- NCT01108510
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.
Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 698
- 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 days following the last dose of study drug.
- Age ≥ 18 years
- Life expectancy ≥ 1 year
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATV+COBI+FTC/TDF ATV COBI + RTV placebo + ATV + FTC/TDF once daily ATV+RTV+FTC/TDF ATV RTV + COBI placebo + ATV + FTC/TDF once daily ATV+RTV+FTC/TDF FTC/TDF RTV + COBI placebo + ATV + FTC/TDF once daily ATV+RTV+FTC/TDF COBI placebo RTV + COBI placebo + ATV + FTC/TDF once daily ATV+COBI+FTC/TDF FTC/TDF COBI + RTV placebo + ATV + FTC/TDF once daily ATV+COBI+FTC/TDF RTV placebo COBI + RTV placebo + ATV + FTC/TDF once daily ATV+COBI+FTC/TDF COBI COBI + RTV placebo + ATV + FTC/TDF once daily ATV+RTV+FTC/TDF RTV RTV + COBI placebo + ATV + FTC/TDF once daily
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Week 48 The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 96 Baseline to Week 96 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 Week 144 The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 48 Baseline to Week 48 Change From Baseline in CD4 Cell Count at Week 144 Baseline to Week 144 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 Week 192 The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 192 Baseline to Week 192
Trial Locations
- Locations (134)
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Oasis Clinic
🇺🇸Los Angeles, California, United States
Peter J Ruane, MD, Inc
🇺🇸Los Angeles, California, United States
Anthony Mills MD Inc
🇺🇸Los Angeles, California, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Gordon E. Crofoot MD PA
🇺🇸Houston, Texas, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Metropolis Medical
🇺🇸San Francisco, California, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Project LORI
🇨🇦Montreal, Canada
Kaiser Permanente Medical Center, Clinical Trials Unit
🇺🇸San Francisco, California, United States
Whitman-Walker Clinic
🇺🇸Washington, District of Columbia, United States
Living Hope Clinical Foundation
🇺🇸Long Beach, California, United States
Health for Life Clinic PLLC
🇺🇸Little Rock, Arkansas, United States
Broward Health/Comprehensive Care Center
🇺🇸Fort Lauderdale, Florida, United States
SouthWest CARE Center
🇺🇸Santa Fe, New Mexico, United States
Taylor Square Private Clinic
🇦🇺Darlinghurst, New South Wales, Australia
Northside Clinic
🇦🇺Melbourne, Victoria, Australia
Mt Sinai School of Medicine
🇺🇸New York, New York, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
🇺🇸Miami Beach, Florida, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Peter Shalit, M.D.
🇺🇸Seattle, Washington, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
CentralWest Clinical Research
🇺🇸St. Louis, Missouri, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
Saint Michaels Medical Center
🇺🇸Newark, New Jersey, United States
Ricky K. Hsu, MD, PC
🇺🇸New York, New York, United States
Chelsea Village Medical, PC
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
Albion Street Centre
🇦🇺Sydney, New South Wales, Australia
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
St Vincent's Hospital, Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Instituto De Pesquisa Clinica Evandro Chagas
🇧🇷Rio de Janeiro, RJ, Brazil
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Division of Infectious Diseases, Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸Dallas, Texas, United States
Tarrant County Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
Research Access Network
🇺🇸Houston, Texas, United States
Melbourne Sexual Health Centre
🇦🇺Carlton, Victoria, Australia
University of Ghent
🇧🇪Ghent, Belgium
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Holdsworth House Medical practice
🇦🇺Sydney, New South Wales, Australia
CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
Instituto De Infectologia Emilo Ribas
🇧🇷São Paulo, Brazil
Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
🇨🇦Montréal, Quebec, Canada
Crt-Dst/Aids
🇧🇷São Paulo, Brazil
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
🇨🇦Toronto, Ontario, Canada
Clinique medicale l'Actuel
🇨🇦Montreal, Quebec, Canada
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
🇫🇷Lyon, France
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Service des Maladies Infectieuses, CHU de Caen
🇫🇷Caen, France
Bichat Hospital
🇫🇷Paris, France
Infektio Research GmbH / Infektiologikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Centre François Magendie, Hôpital du Haut Lévêque
🇫🇷Pessac, France
ICH Study Center Hamburg
🇩🇪Hamburg, Germany
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
🇩🇪Hamburg, Germany
Tenon Hospital, UPMC
🇫🇷Paris, France
Maladies Infectieuses Dpt
🇫🇷Paris, France
EPIMED GmbH
🇩🇪Berlin, Germany
Medizinische Universitätsklinik
🇩🇪Bonn, Germany
Hospital de Santa Maria - CHLN
🇵🇹Lisbon, Portugal
Dipartimento di Malattie Infettive
🇮🇹Torino, Italy
University of Cologne, Department of Internal Medicine
🇩🇪Koln, Germany
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
🇮🇹Milano, Italy
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Instituto de Investigacion Clentifica del Sur
🇵🇷Ponce, Puerto Rico
Ramathibodi Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich
🇨🇭Zürich, Switzerland
HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
🇹🇭Bangkok, Thailand
Barts and the London NHS Trust
🇬🇧London, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, East Sussex, United Kingdom
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
CHU de Nantes Hopital de l'Hotel Dieu
🇫🇷Nantes, France
Department of Infectious Diseases, Saint-Louis hospital
🇫🇷Paris, France
Centre Hospitalier de Tourcoing
🇫🇷Tourcoing, France
Hopital Saint Antoine, Service De Maladies Infectieuses
🇫🇷Paris, France
University Health Network, Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Brasilmed Assistencia Medica E Pesquisas
🇧🇷São Paulo, Brazil
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
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
🇺🇸Los Angeles, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
East Carolina University, The Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Carolinas Medical Center-Myers Park
🇺🇸Charlotte, North Carolina, United States
Garcia's Family Health Group
🇺🇸Harlingen, Texas, United States
LKH Graz West
🇦🇹Graz, Austria
Allgemeines Krankenhaus
🇦🇹Vienna, Austria
URDIP Faculdade de Medicina do ABC
🇧🇷Santo Andre, Sao Paulo, Brazil
Universidade Estadual de Campinas
🇧🇷Campinas, Brazil
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
Rigshospitalet, Infektionsklinik 5112
🇩🇰Copenhagen, Denmark
Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
🇫🇷Marseille, France
Onze lieve vrouw gasthuis
🇳🇱Amsterdam, Netherlands
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Serviço de Doenças Infecciosas, Hospital de São João
🇵🇹Porto, Portugal
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
🇮🇹Roma, Italy
CHUV
🇨🇭Lausanne, VD, Switzerland
Universitätsklinik für Infektiologie, Universitätsspital Bern
🇨🇭Bern, Switzerland
Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Khon Kaen University
🇹🇭Khon Kaen, Thailand
Guys and St. Thomas' NHS Trust
🇬🇧London, United Kingdom
Courtyard Clinic, St. Georges Hospital
🇬🇧London, United Kingdom
Homerton University Hospital
🇬🇧London, United Kingdom
Siriraj Hospital
🇹🇭Bangkok, Thailand
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Group
🇺🇸Sacramento, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Idocf/ Valuhealthmd, Llc
🇺🇸Orlando, Florida, United States
Hôpital Universitaire Erasme - ULB
🇧🇪Brussels, Belgium
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
🇦🇹Vienna, Austria
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Instituto Dominicano de Estudios Virologicos - IDEV
🇩🇴Santo Domingo, Dominican Republic
Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
🇹🇭Chiang Mai, Thailand
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Wake Forest University Health Sciences
🇺🇸Winston Salem, North Carolina, United States
Montefiore Medical Center - AIDS Center
🇺🇸Bronx, New York, United States