Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01797445
First received: February 20, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult participants as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.


Condition Intervention Phase
HIV
HIV Infections
Drug: E/C/F/TAF
Drug: E/C/F/TDF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The proportion of participants achieving HIV-1 RNA < 50 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in hip bone mineral density (BMD) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine BMD [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria through Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Week 48 will be summarized.

  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of participants with HIV-1 RNA < 20 copies/mL [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Percent change from baseline in hip and spine BMD at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Week 96 will be summarized.

  • Urine retinol binding protein (RBP) to creatinine ratio [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Urine beta-2-microglobulin to creatinine ratio [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will receive E/C/F/TAF for 96 weeks
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) single-tablet regimen administered orally once daily
Active Comparator: E/C/F/TDF
Participants will receive E/C/F/TDF for 96 weeks
Drug: E/C/F/TDF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg (E/C/F/TDF) single-tablet regimen administered orally once daily
Other Name: Stribild®

  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, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis (PEP) up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Females 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
  • Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
  • Age ≥ 18 years

Exclusion Criteria:

  • A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • 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 (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
  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: NCT01797445

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States, 90027
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, Inc.
Los Angeles, California, United States, 90036
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States, 90033
Alameda County Medical Center
Oakland, California, United States, 94602
Stanford University
Palo Alto, California, United States, 94304
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
University of California, Davis Medical Center
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
Kaiser Permanente
San Leandro, California, United States, 94577
Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center
Torrance, California, United States, 90275
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
APEX Research LLC
Denver, Colorado, United States, 80209
United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Yale University
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Whitman-Walker Health
Washington, District of Columbia, United States, 20009
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Infectious Diseases Associates of NW FL
Florida, Florida, United States, 32504
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34952
AIDS Healthcare Foundation
Miami, Florida, United States, 33133
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
Idocf/Valuhealthmd
Orlando, Florida, United States, 32836
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
University of South Florida
Tampa, Florida, United States, 33602
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta ID Group, PC
Atlanta, Georgia, United States, 30309
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Emory University
Atlanta, Georgia, United States, 30309
Georgia Regents University
Augusta, Georgia, United States, 30912
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States, 30033
Mercer University
Macon, Georgia, United States, 31201
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96821
United States, Illinois
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Rush University Medical Center, Section of Infectious Diseases
Chicago, Illinois, United States, 60305
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02111
The Research Institute
West Springfield, Massachusetts, United States, 01105
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072-3436
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Southwest CARE Center
Santa Fe, Minnesota, United States, 87505
United States, Missouri
Central West Clinical Research
St. Louis, Missouri, United States, 63108
Southampton Healthcare, Inc.
St. Louis, Missouri, United States, 63139
United States, New Jersey
ID Care
Hillsborough, New Jersey, United States, 08844
United States, New York
Upstate ID Assoc
Albany, New York, United States, 12208
Albany Medical College
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
Jacobi Medical Center
Bronx, New York, United States, 10461
North Shore University Hospital - Division of Infectious Diseases
Manhasset, New York, United States, 11030
Chelsea Village Medical
New York, New York, United States, 10011
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27599
ID Consultants
Charlotte, North Carolina, United States, 28209
Carolinas Medical Center Myer's Park Clinic
Charlotte, North Carolina, United States, 28207
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University The Brody School of Medicine
Greenville, North Carolina, United States, 27834
Rosedale Infectious Disseases
Huntersville, North Carolina, United States, 28078
Wake Forest University Health Sciences
Winston-salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
University of South Carolina/Palmetto Health
Columbia, South Carolina, United States, 29203
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
St. Hope Foundation, Inc.
Bellaire, Texas, United States, 77401
Trinity Health & Wellness Center / AIDS Arms, Inc.
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States, 75219
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Gordon E. Crofoot, MD, PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Research Access Network
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
Rockwood Pulmonary and Critical Care
Spokane, Washington, United States, 99204
Canada, Quebec
Research Institute of McGill University Health Care
Montreal, Quebec, Canada, H2X 2P4
Canada
Clinique Medicale Du Quartier Latin
Montreal, Canada, H2L 5B1
Clinique Medicale L'actuel
Montreal, Canada, H2L 4P9
University Health Network/Toronto General Hospital
Toronto, Canada, M4N 3M5
Maple Leaf Research
Toronto, Canada, M5G 1K2
Spectrum Health Care
Vancouver, Canada, V6Z 2T1
Dominican Republic
Instituto Dominicano de Estudios Virologicos--IDEV
Santo Domingo, Dominican Republic, 99999
France
Hopital de la Croix Rousse
Lyon, France, 69004
University Hospital of Montpellier (CHU-Gui de Chauliac)
Montpellier, France, 34295
Archet 1 CHU de Nice, Department of Infectiology
Nice, France, 06200
Hôpital Bichat Claude Bernard
Paris, France, 75018
Hopital Tenon
Paris, France, 75020
Hopital Saint Antoine
Paris, France, 75012
Hopital Pitie Salpetriere
Paris, France, 75651
Saint Louis Hospital of Infectious Diseases
Paris, France, 75010
CH Tourcoing
Tourcoing, France, 59208
Italy
Universitaria di Bologna-Policlicnico S' Orsola Malpighi
Bologna, Italy, 40138
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Università degli Studi di Modena e Reggio Emilia
Modena, Italy, 41124
Ospedale Infermi di Rimini
Rimini, Italy, 47900
Mexico
Hospital Civil de Guadalajara
Guadalajara, Mexico, 44280
Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"
Mexico City, Mexico, 14080
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 AC
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Portugal
Serviço de Doenças Infecciosas, HUC-CHUC, EPE
Coimbra, Portugal, 3000-075
Hospital Santo Antonio dos Capuchos
Lisboa, Portugal, 1169-050
Hospital de Santa Maria - CHLN, EPE
Lisbon, Portugal, 1649-035
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, Portugal, 4369-004
Puerto Rico
Hope Clinical Research
San Juan, Puerto Rico, 00909
University of Puerto Rico ACTU
San Juan, Puerto Rico, 00935
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41685
Venhalsan / Sodersjukhuset
Stockholm, Sweden, 11883
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
United Kingdom
Whittall Street Clinic
Birmingham, United Kingdom, B4 6DH
Heart Of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 1ES
Brownlee Centre, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Barts Health NHS Trust
London, United Kingdom, E11BB
Kings College Hospital
London, United Kingdom, SE5 9RJ
Mortimer Market Centre
London, United Kingdom, WC1E 6JB
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Chelsea and Westminster
London, United Kingdom, SW10 9NH
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797445     History of Changes
Other Study ID Numbers: GS-US-292-0111, 2013-000102-37
Study First Received: February 20, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
Treatment Naive
HIV 1 Infected
Women
Female

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

ClinicalTrials.gov processed this record on July 24, 2014