Clinical Trials


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

This study has been completed
Gilead Sciences

Information provided by (Responsible Party)
Gilead Sciences Identifier

First received: November 17, 2011
Last updated: May 6, 2016
Last Verified: May 2016
History of Changes


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.

Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections

Drug : PI
Drug : RTV
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 Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/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: 438
Study Start Date: November 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 (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Active Comparator: PI+RTV+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.
Drug: PI

PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)

Drug: RTV

RTV administered according to prescribing information FTC/TDF administered according to prescribing information


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

Other Name: Truvada
Drug: Stribild

Stribild (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 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

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 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

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: NCT01475838


United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
Pueblo Family Physicians
Phoenix, Arizona, United States, 85015
United States, California
AIDS Healthcare Foundation
Beverly Hills, California, United States, 90211
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Kaiser Permanente
Hayward, California, United States, 94545
Kaiser Permanente
Los Angeles, California, United States, 90027
Peter J. Ruane, M.D., Inc.
Los Angeles, California, United States, 90036
OASIS Clinic
Los Angeles, California, United States, 90043
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Stanford University
Palo Alto, California, United States, 94304
University of California, Davis
Sacramento, California, United States, 95817
Kaiser Permanente
Sacramento, California, United States, 95841
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
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, PC
Washington, District of Columbia, United States, 20036
United States, Florida
Gary Richmond, MD
Fort Lauderdale, Florida, United States, 33316
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States, 34982
The Kinder Medical Group
Miami, Florida, United States, 33133
Orlando Immunology Center
Orlando, Florida, United States, 32803
Idocf/Valuhealthmd, Llc
Orlando, Florida, United States, 32806
Infectious Diseases Associates of NW FL, P.A.
Pensacola, Florida, United States, 32504
AHF Health Positive Tampa Bay
Safety Harbor, Florida, United States, 34695
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta ID Group
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University Division of Infectious Diseases
Chicago, Illinois, United States, 60611
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
United States, Minnesota
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
I.D. Care Associates PA
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
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
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Uptown Physicians Group
Dallas, Texas, United States, 75204
Southwest Infectious Disease Clinical Research, 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 Crofoot Md, Pa
Houston, Texas, United States, 77098
St. Hope Foundation Inc
Houston, Texas, United States, 77401
Innsbruck Medical University
Innsbruck, Austria, A 6020
Univ.-Kklinik fuer Innere Medizin III
Salzburg, Austria, 5020
Medical University of Vienna
Vienna, Austria, 1090
Wien, Austria, 1140
UCL Saint Luc
Brussels, Belgium, 01200
University Hospital Ghent
Ghent, Belgium, 9000
CHU Sart Tilman
Liege, Belgium, 4000
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
CHU de Besancon, Hopital Saint-Jacques
Besançon, France, 25030
Hôpital de la Croix-Rousse
Lyon, France, 69317
CHU Hôpital Gui de Chauliac
Montpellier, France, 34295
Archet 1 Chu Nice Department of Infectology
Nice, France, 06202
Maladies Infectieuses Dpt
Paris Cedex 13, France, 75651
Saint-Louis Hospital
Paris, France, 75010
Hopital Saint Antoine
Paris, France, 75012
Hôpital Bichat-Claude Bernard
Paris, France, 75018
hôpital Tenon
Paris, France, 75020
Hôpital Haut Lévêque
Pessac, France, 33604
Epimed GmbH
Berlin, Germany, 12157
University of Bonn
Bonn, Germany, 53127
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
Essen, Germany, 45147
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
Frankfurt, Germany, 60590
ICH Study Center
Hamburg, Germany, 20146
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Infektlonsambulanz Unlkllnik Koln
Koln, Germany, 50937
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
Munich, Germany, 80336
Ospedali Riuniti
Bergamo, Italy, 24128
Fondazione Centro San Raffaele
Milano, Italy, 20127
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milano, Italy, 20142
Ospedale Luigi Sacco
Milano, Italy, 20157
National Institute for Infectious Diseases "L. Spallanzani"
Rome, Italy, 00149
University of Torino, Dept of Infectious Disease
Torino, Italy, 10122
HHP Hospital de Cascais
Alcabideche, Portugal, 2755
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
Lisboa, Portugal, 1150-069
Hospital de Santa Maria-CHLN, EPE
Lisbon, Portugal, 1049-035
Puerto Rico
Clinical Research Puert Rico
San Juan, Puerto Rico, 00909
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
Hospital General Universitario Alicante
Alicante, Spain, 03010
Hospital clinic
Barcelona, Spain, 08036
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
Barcelona, Spain, 08907
Hospital Germans Trias I Pujol
Barcelona, Spain, 08916
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03202
Infectious Diseases Department, Hospital Carlos III
Madrid, Spain, 28029
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain, 28760
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Geneva University Hospital
Geneva, Switzerland, 1205
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
Zurich, Switzerland, 8091
Zentrum fur Infektionskrankheiten
Zurich, Switzerland, CH-8038
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN21ES
Royal Free Hampstead NHS Trust
London, United Kingdom, NW32QG
Chelsea and Westminster
London, United Kingdom, SW109NH

Sponsors and Collaborators

Gilead Sciences


Study Director: Thai Nguyen-Cleary Gilead Sciences
More Information

More Information

Responsible Party: Gilead Sciences Identifier: NCT01475838   History of Changes  
Other Study ID Numbers: GS-US-236-0115  
Study First Received: November 17, 2011  
Last Updated: May 6, 2016  

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 02, 2020
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