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:
NCT01780506
First received: January 16, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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-naive adults 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
Drug: Placebo to match E/C/F/TDF
Drug: Placebo to match E/C/F/TAF
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:
  • 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 [ 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 through Week 96 [ 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: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
E/C/F/TAF single-tablet regimen (STR) plus placebo to match E/C/F/TDF 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) administered orally once daily
Drug: Placebo to match E/C/F/TDF
Placebo to match E/C/F/TDF tablets administered orally once daily
Active Comparator: E/C/F/TDF
E/C/F/TDF STR plus placebo to match E/C/F/TAF for 96 weeks
Drug: E/C/F/TDF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) administered orally once daily
Other Name: Stribild®
Drug: Placebo to match E/C/F/TAF
Placebo to match E/C/F/TAF tablets administered orally once daily

  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), post-exposure prophylaxis (PEP), or treatment during pregnancy, up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (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
  • Male subjects 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
  • 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
  • Female subjects 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
  • Subjects 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 subject 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 subject unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Subjects receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or subjects 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: NCT01780506

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
University of California, Los Angeles
Los Angeles, California, United States, 90035
East Bay AIDS Center
Oakland, California, United States, 94609
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
University of California, San Diego
San Diego, California, United States, 92103
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Apex Research, LLC
Denver, Colorado, United States, 80209
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
Capital Medical Associates, P.C.
Washington, District of Columbia, United States, 20036
Dupont Circle Physicians Group, P.C.
Washington, District of Columbia, United States, 20009
United States, Florida
Gary Richmond, MD, PA, Inc.
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
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ValuHealthMD, LLC
Orlando, Florida, United States, 32806
Infectious Diseases Associates
Pensacola, Florida, United States, 32504
St. Joseph's Comprenhensive Research Inisitute
Tampa, Florida, United States, 33614
The University of South Florida
Tampa, Florida, United States, 33602
Infectious Disease Research Institute Inc.
Tampa, Florida, United States, 33614
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Emory University
Atlanta, Georgia, United States, 30308
Atlanta ID Group, PC
Atlanta, Georgia, United States, 30309
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States, 30033
Mercer University School of Medicine
Macon, Georgia, United States, 31201
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Community Research Initative
Boston, Massachusetts, United States, 02111
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Central West Clinical Research, Inc.
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
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Upstate Infectious Diseases Associates
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Hospital Queens
Flushing, New York, United States, 11355
North Shore University Hospital - Division of Infectious Diseases
Manhasset, New York, United States, 11030
Mount Sinai School of Medicine
New York, New York, United States, 10029
Jacobi Medical Center
South Bronx, New York, United States, 10461
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Infectious Disease Consultants, PA
Charlotte, North Carolina, United States, 28209
Carolinas Medical Center Myer's Park Clinic
Charlotte, North Carolina, United States, 28207
Duke University
Durham, North Carolina, United States, 22710
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
United States, Ohio
Summa Health Care Center
Akron, Ohio, United States, 44304
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
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
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina School of Medicine
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 and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States, 75208
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Garcias' Family Health Group
Harlingen, Texas, United States, 78550
Gordon E. Crofoot, MD, PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
Taylor Square Private Clinic
Darlington, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
East Sydney Doctors
Sydney, New South Wales, Australia, 2010 NSW
Australia, Victoria
Melbourne Sexual Health Clinic
Carlton, Victoria, Australia, 3053
Austria
DIAID, Department of Dermatology, Medical University Vienna
Vienna, Austria, 1090
Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
Wien, Austria, 1140
Belgium
Hôpital Erasme-ULB
Anderlecht, Brussels, Belgium, 1070
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
Canada, British Columbia
Spectrum Health
Vancouver, British Columbia, Canada, V6Z 2T1
Canada, Manitoba
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Maple Leaf Research
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
Clinique medicale l'Actuel
Montreal, Quebec, Canada, H2L 5B1
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
Clinique OPUS
Montreal, Quebec, Canada, H3A 1T1
Canada
Sunnybrook Health Science Center
Toronto, Canada, M4N 3M5
Italy
Ospedale San Raffaele
Milano, Italy, 20127
Japan
National Center for Global Health and Medicine AIDS Clinical Center
Shinjuku-ku, Tokyo, Japan, 162-8655
Puerto Rico
HOPE Clinical Research
San Juan, Puerto Rico, 00909
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial
Barcelona, Spain, 08036
University Hospital Bellvitge
Barcelona, Spain, 08907
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain, 15706
Switzerland
Universitätsspital Bern
Berne, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
University Hospital, Zurich
Zurich, Switzerland, CH-8091
Thailand
The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
Bangkok, Thailand, 10330
Siriraj Hospital
Bangkok, Thailand, 10700
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Chiang Mai University
Chiang Mai, Thailand, 50200
Khon Kaen University
Khon Kaen, Thailand, 40002
Bamrasnaradura Infectious Diseases Institute
Nontaburi, Thailand, 11000
United Kingdom
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Hal Martin, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01780506     History of Changes
Other Study ID Numbers: GS-US-292-0104, 2012-004458-27
Study First Received: January 16, 2013
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

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

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 September 18, 2014