Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
- Conditions
- HIV InfectionsAcquired Immunodeficiency Syndrome
- Interventions
- Registration Number
- NCT01475838
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 438
- Ability to understand and sign a written informed consent form
- Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit
- Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit
- No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
- Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC
- HIV RNA < 50 copies/mL at screening
- Normal ECG
- Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Estimated glomerular filtration rate ≥ 70 mL/min
- Females of childbearing potential must agree to utilize highly effective contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
- Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Male participants must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be nonheterosexually active, or practice sexual abstinence
- Age ≥ 18 years
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Receiving drug treatment for hepatitis C, or participants who are anticipated to receive treatment for hepatitis C during the course of the study
- Experiencing decompensated cirrhosis
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance abuse that would interfere with compliance
- A 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 requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis
- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
- Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets
- No anticipated need to initiate drugs during the study that are contraindicated
- Receiving other investigational drugs
- Participation in any other clinical trial
- Any other clinical condition or prior therapy that would make the participant 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 PI+RTV+FTC/TDF Stribild Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase. PI+RTV+FTC/TDF PI Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase. Stribild Stribild Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase. PI+RTV+FTC/TDF FTC/TDF Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase. PI+RTV+FTC/TDF RTV Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Week 48 The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Week 96 The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48 Change From Baseline in CD4+ Cell Count at Week 96 Baseline; Week 96
Trial Locations
- Locations (97)
Peter J. Ruane, M.D., Inc.
🇺🇸Los Angeles, California, United States
OASIS Clinic
🇺🇸Los Angeles, California, United States
Gordon Crofoot Md, Pa
🇺🇸Houston, Texas, United States
St. Hope Foundation Inc
🇺🇸Houston, Texas, United States
Uptown Physicians Group
🇺🇸Dallas, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Pueblo Family Physicians
🇺🇸Phoenix, Arizona, United States
Pacific Oaks Medical Group
🇺🇸Beverly Hills, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Anthony Mills MD Inc
🇺🇸Los Angeles, California, United States
Gary Richmond, MD
🇺🇸Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
🇺🇸Fort Pierce, Florida, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
AHF Health Positive Tampa Bay
🇺🇸Safety Harbor, Florida, United States
Atlanta ID Group
🇺🇸Atlanta, Georgia, United States
Northwestern University Division of Infectious Diseases
🇺🇸Chicago, Illinois, United States
Medical University of Vienna
🇦🇹Vienna, Austria
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
🇪🇸Barcelona, Spain
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
Metropolis Medical
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Zentrum fur Infektionskrankheiten
🇨🇭Zurich, Switzerland
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Clinique Medicale Du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Ospedale Luigi Sacco
🇮🇹Milano, Italy
National Institute for Infectious Diseases "L. Spallanzani"
🇮🇹Rome, Italy
University of Torino, Dept of Infectious Disease
🇮🇹Torino, Italy
Hôpital Bichat-Claude Bernard
🇫🇷Paris, France
Kaiser Permanente
🇺🇸Sacramento, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
Dupont Circle Physicians Group, P.C
🇺🇸Washington, District of Columbia, United States
Capital Medical Associates, PC
🇺🇸Washington, District of Columbia, United States
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
🇺🇸Chicago, Illinois, United States
Idocf/Valuhealthmd, Llc
🇺🇸Orlando, Florida, United States
Saint-Louis Hospital
🇫🇷Paris, France
Tarrant County Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
Hopital Saint Antoine
🇫🇷Paris, France
hôpital Tenon
🇫🇷Paris, France
I.D. Care Associates PA
🇺🇸Hillsborough, New Jersey, United States
Greiger Clinic
🇺🇸Mt. Vernon, New York, United States
ID Consultants, P.A.
🇺🇸Charlotte, North Carolina, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
Univ.-Kklinik fuer Innere Medizin III
🇦🇹Salzburg, Austria
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Maladies Infectieuses Dpt
🇫🇷Paris Cedex 13, France
Hôpital Haut Lévêque
🇫🇷Pessac, France
Otto-Wagner-Spital
🇦🇹Wien, Austria
CHU Hôpital Gui de Chauliac
🇫🇷Montpellier, France
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
CHU Sart Tilman
🇧🇪Liege, Belgium
Archet 1 Chu Nice Department of Infectology
🇫🇷Nice, France
Innsbruck Medical University
🇦🇹Innsbruck, Austria
UCL Saint Luc
🇧🇪Brussels, Belgium
University Hospital Ghent
🇧🇪Ghent, Belgium
Epimed GmbH
🇩🇪Berlin, Germany
CHU de Besancon, Hopital Saint-Jacques
🇫🇷Besançon, France
University of Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
🇩🇪Essen, Germany
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
🇩🇪Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
🇩🇪Hamburg, Germany
Fondazione Centro San Raffaele
🇮🇹Milano, Italy
Infektlonsambulanz Unlkllnik Koln
🇩🇪Koln, Germany
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
🇩🇪Munich, Germany
Ospedali Riuniti
🇮🇹Bergamo, Italy
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
🇵🇹Lisboa, Portugal
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
🇮🇹Milano, Italy
Hospital General Universitario Alicante
🇪🇸Alicante, Spain
HHP Hospital de Cascais
🇵🇹Alcabideche, Portugal
Hospital de Santa Maria-CHLN, EPE
🇵🇹Lisbon, Portugal
Clinical Research Puert Rico
🇵🇷San Juan, Puerto Rico
University of Puerto Rico School of Medicine
🇵🇷San Juan, Puerto Rico
Geneva University Hospital
🇨🇭Geneva, Switzerland
Hospital clinic
🇪🇸Barcelona, Spain
Hospital Germans Trias I Pujol
🇪🇸Barcelona, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Chelsea and Westminster
🇬🇧London, United Kingdom
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
🇨🇭Zurich, Switzerland
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
Royal Free Hampstead NHS Trust
🇬🇧London, United Kingdom
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
The Kansas City Free Health Clinic
🇺🇸Kansas City, Missouri, United States
Infectious Diseases Department, Hospital Carlos III
🇪🇸Madrid, Spain
University of California, Davis
🇺🇸Sacramento, California, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Clinical Research, Inc
🇺🇸Dallas, Texas, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Infectious Diseases Associates of NW FL, P.A.
🇺🇸Pensacola, Florida, United States
ICH Study Center
🇩🇪Hamburg, Germany
AIDS Healthcare Foundation
🇺🇸Beverly Hills, California, United States