This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen (STR)
relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI)
plus FTC/TDF 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 stable on the current formulation(s) of an antiretroviral (ARV) regimen consisting
of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit.
This includes those who began a regimen with individual drug components and
subsequently simplified to include a fixed-dose combination formulation of the same
drugs.
- Be on the first or second antiretroviral regimen with 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 the screening visit
- Normal ECG
- Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
- Total bilirubin ≤ 1. 5 mg/dL
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Estimated glomerular filtration rate ≥ 70 mL/min
- Females of childbearing potential must agree to utilize protocol recommended
contraception methods or be nonheterosexually active, practice sexual abstinence from
screening throughout the duration of the study period and for 12 weeks for
participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants
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 protocol-recommended methods of contraception
during heterosexual intercourse or be nonheterosexually active, and practice sexual
abstinence from the screening visit.
- Age ≥ 18 years
Exclusion Criteria:
- 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 those 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 (KS), basal cell carcinoma, or resected, noninvasive
cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not
have received any systemic therapy for KS within 30 days of baseline and must not be
anticipated to require systemic therapy during the study.
- Active, serious infections requiring parenteral antibiotic or antifungal therapy
within 30 days prior to baseline
- 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 EVG, COBI, FTC, TDF; or those with any known allergies to the excipients of
EVG/COBI/FTC/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
Holdsworth House Medical Practice, Darlinghurst NSW 2010, Australia
Prahran Market Clinic, South Yarra VIC 3141, Australia
East Sydney Doctors, Sydney NSW 2010, Australia
Medical University of Vienna, Wien 1090, Austria
Otto Wagner Spital, Wien 1140, Austria
SEAMEO Regional Centre for Tropical Medicine, Antwerpen 2000, Belgium
Hôpitaux IRIS Sud, Bruxelles 1050, Belgium
University Hospital of Leuven, Leuven 3000, Belgium
CHU de Besancon - Hopital Saint-Jacques, Besancon 25030, France
Groupe Hospitalier Pellegrin, Bordeaux 33079, France
Hopital Bichat Claude Bernard, Paris 75018, France
Hopital Saint Antoine, Paris 75571, France
Hopital Saint Louis, Paris 75010, France
EPIMED GmbH, Berlin 12157, Germany
MIB Dienstleistung GmbH, Berlin 13353, Germany
Medizinische Universitätsklinik, Bonn 53127, Germany
Infektiologikum, Frankfurt 60596, Germany
Universitatsklinikum Freiburg, Freiburg 79106, Germany
ICH Study Center, Hamburg 20146, Germany
MUC Research GmbH, München 80335, Germany
Azienda Ospedaliera Ospedale di Circolo Busto Arsizio, Busto Arsizio/Varese 21052, Italy
Fondazione Centro San Raffaele del Monte Tabor, Milano 20127, Italy
Ospedale Luigi Sacco, Milano 20157, Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS, Roma 00149, Italy
Policlinico Universitario Agostino Gemelli, Rome 1214, Italy
Hospital de Santa Maria - CHLN EPE, Lisboa 1649-035, Portugal
Clinical Research Puerto Rico Inc, San Juan 00909, Puerto Rico
Hospital del Mar, Barcelona 8003, Spain
Hospital General Universitario Gregorio Maranon, Madrid 28007, Spain
Hospital La Fe de Valencia, Valencia 46009, Spain
Brighton and Sussex University Hospitals NHS Trust, Brighton BN2 1ES, United Kingdom
Western General Hospital, Edinburgh EH4 2XU, United Kingdom
Chelsea & Westminster Hospital, London SW10 9TH, United Kingdom
Homerton University Hospital, London E9 6SR, United Kingdom
South London Healthcare NHS Trust, London SE1 1EE, United Kingdom
St. Thomas' Hospital, London SE17EH, United Kingdom
Spectrum Medical Group, Phoenix, Arizona 85012, United States
AHF Research Center, Beverly Hills, California 90211, United States
Pacific Oak 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
OASIS Clinic, Los Angeles, California 90059, United States
Peter J. Ruane, MD, Inc., Los Angeles, California 90036, United States
Alameda County Medical Center, Oakland, California 94602, United States
Kaiser Permanente Medical Group, Sacramento, California 95825, United States
La Playa Medical Group and Clinical Research, San Diego, California 92103, United States
Kaiser Permanente, San Francisco, California 94118, United States
Metropolis Medical, San Francisco, California 94109, United States
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña 08025, Spain
Capital Medical Associates, P.C., Washington, District of Columbia 20036, United States
Dupont Circle Physicians Group, P.C., Washington, District of Columbia 20009, United States
Gary Richmond MD, PA, Inc, Fort Lauderdale, Florida 33316, United States
Midway Immunology and Research, Fort Pierce, Florida 34982, United States
The Kinder Medical Group, Miami, Florida 33133, United States
Orlando Immunology Center, Orlando, Florida 32803, United States
ValuHealth MD, LLC, Orlando, Florida 32806, United States
Infectious Diseases Associates of Northwest Florida, Pensacola, Florida 32504, United States
Health Positive, Safety Harbor, Florida 34684, United States
Hospital Clinico Universitario de Santiago, Santiago de Compostela, Galicia 15706, Spain
Atlanta ID Group, PC, Atlanta, Georgia 30309, United States
Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States
Be Well Medical Center, Berkley, Michigan 48072, United States
HIV Program Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
The Kansas City Free Health Clinic, Kansas City, Missouri 64111, United States
ID Care, 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
Aaron Diamond AIDS Research Center, New York, New York 10016, United States
ID Consultants, P.A., Charlotte, North Carolina 28209, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
Maple Leaf Medical Clinic, Toronto, Ontario M5B1L6, Canada
Sunnybrook Health Sciences Center, Toronto, Ontario M4N 3M5, Canada
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Clinique Medicale Du Quartier Latin, Montreal, Quebec H2L 5B1, Canada
Southwest Infectious Disease Clinical Researach Inc, Dallas, Texas 75219, United States
Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States
Gordon E. Crofoot MD, PA, Houston, Texas 77098, United States
Therapeutic Concepts PA, Houston, Texas 77004, United States
Clinical Alliance for Research & Education - Infectious Disease, Annandale, Virginia 22003, United States