This study will evaluate the non-inferiority of Stribild (elvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen
relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- 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
- 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 according to the Cockcroft-Gault
formula
- 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 subjects 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 subjects 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 non-heterosexually active, or practice sexual abstinence
Exclusion Criteria:
- 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 subjects 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
- Subjects receiving ongoing therapy with any of the medications, including drugs not
to be used with EVG, COBI, FTC, TDF or subjects with any known allergies to the
excipients of EVG/COBI/FTC/TDF tablets, or Truvada® 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 subject unsuitable
for the study or unable to comply with the dosing requirements
Innsbruck Medical University, Innsbruck A 6020, Austria
Univ.-Kklinik fuer Innere Medizin III, Salzburg 5020, Austria
Medical University of Vienna, Vienna 1090, Austria
Otto-Wagner-Spital, Wien 1140, Austria
UCL Saint Luc, Brussels 01200, Belgium
University Hospital Ghent, Ghent 9000, Belgium
CHU Sart Tilman, Liege 4000, Belgium
CHU de Besancon, Hopital Saint-Jacques, Besançon 25030, France
Hôpital de la Croix-Rousse, Lyon 69317, France
CHU Hôpital Gui de Chauliac, Montpellier 34295, France
Archet 1 Chu Nice Department of Infectology, Nice 06202, France
Maladies Infectieuses Dpt, Paris Cedex 13 75651, France
Hopital Saint Antoine, Paris 75012, France
Hôpital Bichat-Claude Bernard, Paris 75018, France
hôpital Tenon, Paris 75020, France
Saint-Louis Hospital, Paris 75010, France
Hôpital Haut Lévêque, Pessac 33604, France
Epimed GmbH, Berlin 12157, Germany
University of Bonn, Bonn 53127, Germany
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz, Essen 45147, Germany
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68, Frankfurt 60590, Germany
ICH Study Center, Hamburg 20146, Germany
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie, Hamburg 20246, Germany
Medizinische Hochschule Hannover, Hannover 30625, Germany
Infektlonsambulanz Unlkllnik Koln, Koln 50937, Germany
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen, Munich 80336, Germany
Ospedali Riuniti, Bergamo 24128, Italy
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital, Milano 20142, Italy
Fondazione Centro San Raffaele, Milano 20127, Italy
Ospedale Luigi Sacco, Milano 20157, Italy
National Institute for Infectious Diseases "L. Spallanzani", Rome 00149, Italy
University of Torino, Dept of Infectious Disease, Torino 10122, Italy
HHP Hospital de Cascais, Alcabideche 2755, Portugal
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa, Lisboa 1150-069, Portugal
Hospital de Santa Maria-CHLN, EPE, Lisbon 1049-035, Portugal
Clinical Research Puert Rico, San Juan 00909, Puerto Rico
University of Puerto Rico School of Medicine, San Juan 00935, Puerto Rico
Hospital General Universitario Alicante, Alicante 03010, Spain
Hospital clinic, Barcelona 08036, Spain
Hospital Germans Trias I Pujol, Barcelona 08916, Spain
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service., Barcelona 08907, Spain
Hospital General Universitario de Elche, Elche, Alicante 03202, Spain
Hospital La Paz, Madrid 28760, Spain
Hospital Ramon y Cajal, Madrid 28034, Spain
Infectious Diseases Department, Hospital Carlos III, Madrid 28029, Spain
Hospital Virgen del Rocio, Sevilla 41013, Spain
Geneva University Hospital, Geneva 1205, Switzerland
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology, Zurich 8091, Switzerland
Zentrum fur Infektionskrankheiten, Zurich CH-8038, Switzerland
Brighton and Sussex University Hospitals NHS Trust, Brighton BN21ES, United Kingdom
Chelsea and Westminster, London SW109NH, United Kingdom
Royal Free Hampstead NHS Trust, London NW32QG, United Kingdom
Pueblo Family Physicians, Phoenix, Arizona 85015, United States
Spectrum Medical Group, Phoenix, Arizona 85012, United States
AIDS Healthcare Foundation, Beverly Hills, California 90211, United States
Pacific Oaks Medical Group, Beverly Hills, California 90211, United States
Kaiser Permanente, Hayward, California 94545, United States
Anthony Mills MD Inc, Los Angeles, California 90069, United States
Kaiser Permanente, Los Angeles, California 90027, United States
OASIS Clinic, Los Angeles, California 90043, United States
Peter J. Ruane, M.D., Inc., Los Angeles, California 90036, United States
Stanford University, Palo Alto, California 94304, United States
Kaiser Permanente, Sacramento, California 95841, United States
University of California, Davis, Sacramento, California 95817, United States
La Playa Medical Group and Clinical Research, San Diego, California 92103, United States
Kaiser Permanente San Francisco, San Francisco, California 94118, United States
Metropolis Medical, San Francisco, California 94109, United States
Capital Medical Associates, PC, Washington, District of Columbia 20036, United States
Dupont Circle Physicians Group, P.C, Washington, District of Columbia 20009, United States
Gary Richmond, MD, Fort Lauderdale, Florida 33316, United States
Midway Immunology & Research Center, LLC, Fort Pierce, Florida 34982, United States
The Kinder Medical Group, Miami, Florida 33133, United States
Idocf/Valuhealthmd, Llc, Orlando, Florida 32806, United States
Orlando Immunology Center, Orlando, Florida 32803, United States
Infectious Diseases Associates of NW FL, P.A., Pensacola, Florida 32504, United States
AHF Health Positive Tampa Bay, Safety Harbor, Florida 34695, United States
St. Joseph's Comprehensive Research Institute, Tampa, Florida 33614, United States
Atlanta ID Group, Atlanta, Georgia 30309, United States
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center, Chicago, Illinois 60612, United States
Northwestern University Division of Infectious Diseases, Chicago, Illinois 60611, United States
Be Well Medical Center, Berkley, Michigan 48072, United States
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
The Kansas City Free Health Clinic, Kansas City, Missouri 64111, United States
I.D. Care Associates PA, Hillsborough, New Jersey 08844, United States
Saint Michael's Medical Center, Newark, New Jersey 07102, United States
South Jersey Infectious Disease, Somers Point, New Jersey 08244, United States
Greiger Clinic, Mt. Vernon, New York 10550, United States
ID Consultants, P.A., Charlotte, North Carolina 28209, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Clinique Medicale Du Quartier Latin, Montreal, Quebec H2L 5B1, Canada
Southwest Infectious Disease Clinical Research, Inc, Dallas, Texas 75219, United States
Uptown Physicians Group, Dallas, Texas 75204, United States
Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States
Gordon Crofoot Md, Pa, Houston, Texas 77098, United States
St. Hope Foundation Inc, Houston, Texas 77401, United States
Therapeutic Concepts, PA, Houston, Texas 77004, United States