Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside 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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01495702
First received: December 14, 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 non-nucleoside 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: Stribild
Drug: TVD
Drug: NNRTI
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 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

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: NNRTI+TVD
Participants will be randomized to remain on their current antiretroviral regimen consisting of a NNRTI plus TVD for 96 weeks.
Drug: TVD
Truvada (TVD) administered according to prescribing information
Other Name: Truvada®
Drug: NNRTI
Allowed non-nucleoside reverse transcriptase inhibitor (NNRTI) agents administered according to prescribing information, which may include efavirenz, nevirapine, rilpivirine, atripla (EFV/FTC/TDF), or complera (FTC/RPV/TDF)

  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 stable on the current formulation(s) of an antiretroviral (ARV) regimen consisting of a NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes subjects that 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 of second antiretroviral 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 the screening visit
  • Normal ECG
  • Hepatic transaminases ≤ 5 × upper limit of normal (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 non-heterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for subjects on EFV/FTC/TDF or efavirenz or 30 days for the rest of subjects 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 protocol recommended methods of contraception during heterosexual intercourse or be non-heterosexually 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 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, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects 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
  • 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 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 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: NCT01495702

  Hide Study Locations
Locations
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
Anthony Mills MD Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
OASIS Clinic
Los Angeles, California, United States, 90059
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
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 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
Gordon E. Crofoot MD, PA
Houston, Texas, United States, 77098
Therapeutic Concepts PA
Houston, Texas, United States, 77004
United States, Virginia
Clinical Alliance for Research & Education - Infectious Disease
Annandale, Virginia, United States, 22003
Australia
Holdsworth House Medical Practice
Darlinghurst, Australia, NSW 2010
Prahran Market Clinic
South Yarra, Australia, VIC 3141
East Sydney Doctors
Sydney, Australia, NSW 2010
Austria
Medical University of Vienna
Wien, Austria, 1090
Otto Wagner Spital
Wien, Austria, 1140
Belgium
SEAMEO Regional Centre for Tropical Medicine
Antwerpen, Belgium, 2000
Hôpitaux IRIS Sud
Bruxelles, Belgium, 1050
University Hospital of Leuven
Leuven, Belgium, 3000
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B1L6
Canada, Quebec
Clinique Medicale Du Quartier Latin
Montreal, Quebec, Canada, H2L 5B1
France
CHU de Besancon - Hopital Saint-Jacques
Besancon, France, 25030
Groupe Hospitalier Pellegrin
Bordeaux, France, 33079
Hopital Saint Antoine
Paris, France, 75571
Hopital Bichat Claude Bernard
Paris, France, 75018
Hopital Saint Louis
Paris, France, 75010
Germany
MIB Dienstleistung GmbH
Berlin, Germany, 13353
EPIMED GmbH
Berlin, Germany, 12157
Medizinische Universitätsklinik
Bonn, Germany, 53127
Infektiologikum
Frankfurt, Germany, 60596
Universitatsklinikum Freiburg
Freiburg, Germany, 79106
ICH Study Center
Hamburg, Germany, 20146
MUC Research GmbH
München, Germany, 80335
Italy
Azienda Ospedaliera Ospedale di Circolo Busto Arsizio
Busto Arsizio/Varese, Italy, 21052
Ospedale Luigi Sacco
Milano, Italy, 20157
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20127
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, Italy, 00149
Policlinico Universitario Agostino Gemelli
Rome, Italy, 1214
Portugal
Hospital de Santa Maria - CHLN EPE
Lisboa, Portugal, 1649-035
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 00909
Spain
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
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH
South London Healthcare NHS Trust
London, United Kingdom, SE1 1EE
St. Thomas' Hospital
London, United Kingdom, SE17EH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thai Nguyen, 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: NCT01495702     History of Changes
Other Study ID Numbers: GS-US-236-0121, 2011-004963-56
Study First Received: December 14, 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:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Emtricitabine
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 16, 2014