Phase 3b Open Label 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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01475838
First received: November 17, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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/r) 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: Stribild
Drug: RTV
Drug: TVD
Drug: PI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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/r) Plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 as defined by the FDA snapshot analysis [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count at Weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stribild
Participants will be randomized to switch to the Stribild® for 96 weeks.
Drug: Stribild
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
Active Comparator: RTV-boosted PI+TVD
Participants will be randomized to remain on their current antiretroviral regimen consisting of an RTV-boosted PI plus TVD for 96 weeks.
Drug: RTV
Ritonavir (RTV) administered according to prescribing information
Drug: TVD
Truvada (TVD) administered according to prescribing information
Other Name: Truvada®
Drug: PI
Protease inhibitors (PI) administered according to prescribing information, which may include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 × upper limit of normal (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 (C-G) formula
  • Females of childbearing potential must agree to utilize highly effective contraception methods, or be non-heterosexually 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
  • 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 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 (KS), basal cell carcinoma, or resected, non-invasive 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
  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 ClinicalTrials.gov identifier: NCT01475838

  Hide Study Locations
Locations
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
Pueblo Family Physicians
Phoenix, Arizona, United States, 85015
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
AIDS Healthcare Foundation
Beverly Hills, California, United States, 90211
Kaiser Permanente
Hayward, California, United States, 94545
OASIS Clinic
Los Angeles, California, United States, 90043
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, M.D., Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente
Los Angeles, California, United States, 90027
Stanford University
Palo Alto, California, United States, 94304
Kaiser Permanente
Sacramento, California, United States, 95841
University of California, Davis
Sacramento, California, United States, 95817
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Kaiser Permanente San Francisco
San Francisco, California, United States, 94118
Metropolis Medical
San Francisco, California, United States, 94109
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
St. Hope Foundation Inc
Houston, Texas, United States, 77401
Gordon Crofoot Md, Pa
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Austria
Innsbruck Medical University
Innsbruck, Austria, A 6020
Univ.-Kklinik fuer Innere Medizin III
Salzburg, Austria, 5020
Medical University of Vienna
Vienna, Austria, 1090
Otto-Wagner-Spital
Wien, Austria, 1140
Belgium
UCL Saint Luc
Brussels, Belgium, 01200
University Hospital Ghent
Ghent, Belgium, 9000
CHU Sart Tilman
Liege, Belgium, 4000
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
France
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
Hopital Saint Antoine
Paris, France, 75012
Saint-Louis Hospital
Paris, France, 75010
hôpital Tenon
Paris, France, 75020
Hôpital Bichat-Claude Bernard
Paris, France, 75018
Maladies Infectieuses Dpt
Paris Cedex 13, France, 75651
Hôpital Haut Lévêque
Pessac, France, 33604
Germany
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
Italy
Ospedali Riuniti
Bergamo, Italy, 24128
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milano, Italy, 20142
Ospedale Luigi Sacco
Milano, Italy, 20157
Fondazione Centro San Raffaele
Milano, Italy, 20127
National Institute for Infectious Diseases "L. Spallanzani"
Rome, Italy, 00149
University of Torino, Dept of Infectious Disease
Torino, Italy, 10122
Portugal
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
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
Clinical Research Puert Rico
San Juan, Puerto Rico, 00909
Spain
Hospital General Universitario Alicante
Alicante, Spain, 03010
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
Barcelona, Spain, 08907
Hospital Germans Trias I Pujol
Barcelona, Spain, 08916
Hospital clinic
Barcelona, Spain, 08036
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03202
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain, 28760
Infectious Diseases Department, Hospital Carlos III
Madrid, Spain, 28029
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Switzerland
Geneva University Hospital
Geneva, Switzerland, 1205
Zentrum fur Infektionskrankheiten
Zurich, Switzerland, CH-8038
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
Zurich, Switzerland, 8091
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
Investigators
Study Chair: David Piontkowsky, JD, MD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01475838     History of Changes
Other Study ID Numbers: GS-US-236-0115, 2011-004483-30
Study First Received: November 17, 2011
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014