Clinical Trials


Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

This study has been completed
Gilead Sciences

Information provided by (Responsible Party)
Gilead Sciences Identifier

First received: December 14, 2011
Last updated: December 1, 2015
Last Verified: December 2015
History of Changes


This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (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.

Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections

Drug : NNRTI
Drug : FTC/TDF
Drug : Stribild
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: 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:
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: 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 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]

Enrollment: 439
Study Start Date: December 2011
Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Drug: Stribild

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Active Comparator: NNRTI+FTC/TDF
Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.

NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.


FTC/TDF (200/300 mg) administered according to prescribing information

Other Name: Truvada
Drug: Stribild

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria:

  • Ability to understand and sign a written informed consent form
  • Be stable on the current formulation(s) of an antiretroviral 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 screening
  • 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 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01495702


United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
AHF Research Center
Beverly Hills, California, United States, 90211
Pacific Oak Medical Group
Beverly Hills, California, United States, 90211
Kaiser Permanente
Hayward, California, United States, 94545
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
OASIS Clinic
Los Angeles, California, United States, 90059
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Alameda County Medical Center
Oakland, California, United States, 94602
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Metropolis Medical
San Francisco, California, United States, 94109
Kaiser Permanente
San Francisco, California, United States, 94118
United States, District of Columbia
Dupont Circle Physicians Group, P.C.
Washington, District of Columbia, United States, 20009
Capital Medical Associates, P.C.
Washington, District of Columbia, United States, 20036
United States, Florida
Gary Richmond MD, PA, Inc
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research
Fort Pierce, Florida, United States, 34982
The Kinder Medical Group
Miami, Florida, United States, 33133
Orlando Immunology Center
Orlando, Florida, United States, 32803
ValuHealth MD, LLC
Orlando, Florida, United States, 32806
Infectious Diseases Associates of Northwest Florida
Pensacola, Florida, United States, 32504
Health Positive
Safety Harbor, Florida, United States, 34684
United States, Georgia
Atlanta ID Group, PC
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
United States, Minnesota
HIV Program Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
The Kansas City Free Health Clinic
Kansas City, Missouri, United States, 64111
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States, 08844
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New York
Greiger Clinic
Mt. Vernon, New York, United States, 10550
Aaron Diamond AIDS Research Center
New York, New York, United States, 10016
United States, North Carolina
ID Consultants, P.A.
Charlotte, North Carolina, United States, 28209
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Southwest Infectious Disease Clinical Researach Inc
Dallas, Texas, United States, 75219
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Therapeutic Concepts PA
Houston, Texas, United States, 77004
Gordon E. Crofoot MD, PA
Houston, Texas, United States, 77098
United States, Virginia
Clinical Alliance for Research & Education - Infectious Disease
Annandale, Virginia, United States, 22003
Holdsworth House Medical Practice
Darlinghurst, Australia, NSW 2010
Prahran Market Clinic
South Yarra, Australia, VIC 3141
East Sydney Doctors
Sydney, Australia, NSW 2010
Medical University of Vienna
Wien, Austria, 1090
Otto Wagner Spital
Wien, Austria, 1140
SEAMEO Regional Centre for Tropical Medicine
Antwerpen, Belgium, 2000
Hôpitaux IRIS Sud
Bruxelles, Belgium, 1050
University Hospital of Leuven
Leuven, Belgium, 3000
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B1L6
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
CHU de Besancon - Hopital Saint-Jacques
Besancon, France, 25030
Groupe Hospitalier Pellegrin
Bordeaux, France, 33079
Hopital Saint Louis
Paris, France, 75010
Hopital Bichat Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
Berlin, Germany, 12157
MIB Dienstleistung GmbH
Berlin, Germany, 13353
Medizinische Universitätsklinik
Bonn, Germany, 53127
Frankfurt, Germany, 60596
Universitatsklinikum Freiburg
Freiburg, Germany, 79106
ICH Study Center
Hamburg, Germany, 20146
MUC Research GmbH
München, Germany, 80335
Azienda Ospedaliera Ospedale di Circolo Busto Arsizio
Busto Arsizio/Varese, Italy, 21052
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20127
Ospedale Luigi Sacco
Milano, Italy, 20157
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, Italy, 00149
Policlinico Universitario Agostino Gemelli
Rome, Italy, 1214
Hospital de Santa Maria - CHLN EPE
Lisboa, Portugal, 1649-035
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 00909
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña, Spain, 08025
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Hospital del Mar
Barcelona, Spain, 8003
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital La Fe de Valencia
Valencia, Spain, 46009
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 1ES
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Homerton University Hospital
London, United Kingdom, E9 6SR
South London Healthcare NHS Trust
London, United Kingdom, SE1 1EE
St. Thomas' Hospital
London, United Kingdom, SE17EH
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH

Sponsors and Collaborators

Gilead Sciences


Study Director: Damian McColl Gilead Sciences
More Information

More Information

Responsible Party: Gilead Sciences Identifier: NCT01495702   History of Changes  
Other Study ID Numbers: GS-US-236-0121  
Study First Received: December 14, 2011  
Last Updated: December 1, 2015  

Keywords provided by Gilead Sciences:

Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination processed this data on June 01, 2020
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