Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02071082
First received: February 21, 2014
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

This study will assess the efficacy, safety, and tolerability of a single table regimen (STR) containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infected adults through 48 weeks.

Participants will be enrolled into two cohorts:

  • Cohort 1: HIV treatment-naive and HBV treatment-naive
  • Cohort 2: HIV-suppressed

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of participants with plasma HBV DNA levels < 29 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per the FDA snapshot definition [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with plasma HBV DNA levels < 29 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per FDA snapshot definition [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of participants with normalized alanine aminotransferase (ALT) [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of participants with seroconversion [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change in FibroTest® score [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV treatment-naive and HBV treatment-naive
HIV treatment-naive and HBV treatment-naive participants will receive E/C/F/TAF for 48 weeks.
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) STR administered orally once daily with food
Experimental: HIV-suppressed
HIV/HBV co-infected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) STR administered orally once daily with food

  Eligibility

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

Inclusion Criteria:

  • Both Cohorts 1 and 2:

    • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    • HIV/HBV co-infected adult males and non-pregnant and non-lactating females
    • No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy).

      --- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC.

    • Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative
    • Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA
    • Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA
    • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula
    • CD4+ count of > 200 cells/μL
    • Chronic HBV infection as defined by

      • HBsAg positive for ≥ 6 months Or
      • HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or
      • At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and

        • HBsAg positive, or
        • HBeAg positive, or
        • HBV DNA positive
  • Cohort 1 (HIV and HBV treatment naive) only:

    • No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP)
    • No current or prior anti-HBV treatment
    • Plasma HIV-1 RNA level ≥ 500 copies/mL at screening
    • Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL
  • Cohort 2 (HIV suppressed) only:

    • Receiving current antiretroviral regimen for at least 4 consecutive months
    • No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir)
    • Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
    • Documented positive HIV antibody test
    • Screening HBV DNA < 9 log10 IU/mL

Exclusion Criteria:

  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma.
  • Received solid organ or bone marrow transplant
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
  • Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
  • Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
  • 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 the dosing requirements
  • Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
  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: NCT02071082

Contacts
Contact: Marc Lopez 650-372-4456 marc.lopez@gilead.com

  Hide Study Locations
Locations
United States, Arizona
Spectrum Medical Group Recruiting
Phoenix, Arizona, United States, 85012
Contact    602-604-9500      
United States, California
AHF Research Center Recruiting
Beverly Hills, California, United States, 90211
Contact    323-913-1033      
Peter J. Ruane MD, Inc. Recruiting
Los Angeles, California, United States, 90036
Contact    323-954-0400      
Anthony Mills MD, Inc Recruiting
Los Angeles, California, United States, 90069
Contact    310-550-2271      
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact    323-783-3737      
University of California, Davis Withdrawn
Sacramento, California, United States, 95811
United States, District of Columbia
Whitman Walker Health Recruiting
Washington, District of Columbia, United States, 20009
Contact    202-797-3500      
GWU Medical Faculty Associates Recruiting
Washington DC, District of Columbia, United States, 20037
Contact    202-741-2443      
United States, Florida
Barry M. Rodwick MD Recruiting
Clearwater, Florida, United States, 33765
Contact    727-216-6193      
Gary J Richmond M.D.,P.A. Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact    954-524-2250      
Midway Immunology and Research Center Recruiting
Fort Pierce, Florida, United States, 34982
Contact    772-464-9746      
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact    786-413-7546      
AHF-Kinder Medical Group Recruiting
Miami, Florida, United States, 33133
Contact    786-497-4000 ext 232      
AIDS Health Foundation/WPA Recruiting
Miami Beach, Florida, United States, 33139
Contact    305-538-1400 ext 2520      
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Contact    407-647-3960 ext 2112      
SJH Comprehensive Research Institute Recruiting
Tampa, Florida, United States, 33614
Contact    813-870-4760 ext 230      
AIDS Research and Treatment Center of the Treasure Coast Recruiting
Vero Beach, Florida, United States, 32960
Contact    772-978-9556      
Triple O Research Institute PA Recruiting
West Palm Beach, Florida, United States, 33401
Contact    561-855-7871      
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact    404-686-5198      
AIDS Research Consortium of Atlanta Recruiting
Atlanta, Georgia, United States, 30312
Mercer University Recruiting
Macon, Georgia, United States, 31210
Contact    478-301-5846      
United States, Illinois
Howard Brown Health Center Not yet recruiting
Chicago, Illinois, United States, 60613
Contact    773-388-8792      
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact    312-695-5090      
United States, Michigan
Be Well Medical Center PC Recruiting
Berkley, Michigan, United States, 48072
Contact    248-544-9300      
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact    313-916-1784      
United States, Missouri
KC Care Clinic Recruiting
Kansas City, Missouri, United States, 64111
Contact    816-777-2757      
Central West Clinical Research Withdrawn
St. Louis, Missouri, United States, 63108
Southampton Healthcare, Inc. Recruiting
St. Louis, Missouri, United States, 63139
Contact    314-647-2200 ext 116      
United States, New Jersey
Saint Michael's Medical Center Withdrawn
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest CARE Center Recruiting
Santa Fe, New Mexico, United States, 87505
Contact    505-216-0318      
United States, New York
Albany Medical Center Not yet recruiting
Albany, New York, United States, 12208
Contact    518-262-6323      
United States, North Carolina
East Carolina University Withdrawn
Greenville, North Carolina, United States, 27834
Rosedale Infectious Diseases Recruiting
Huntersville, North Carolina, United States, 28078
Contact    704-948-8582      
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
Contact    512-480-9660      
St. Hope Foundation, Inc. Recruiting
Bellaire, Texas, United States, 77401
Contact    713-844-8035      
North Texas Infectious Diseases Consultants Recruiting
Dallas, Texas, United States, 75246
Contact    214-276-5618      
Garcias' Family Health Group Not yet recruiting
Harlingen, Texas, United States, 78550
Contact    956-421-4935      
Gordon E. Crofoot MD PA Recruiting
Houston, Texas, United States, 77098
Contact    713-526-0005      
TheUniversity of Texas Health Science Center Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact    713-500-6703      
Cure C Consortium Recruiting
Houston, Texas, United States, 77004
Contact    713-526-9821      
United States, Washington
Peter Shalit MD Recruiting
Seattle, Washington, United States, 98104
Contact    206-624-1441      
Canada, Ontario
Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact    613-737-8209      
University Health Network/Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact    416-340-4800 ext 6723      
Maple Leaf Research/Maple Leaf Medical Clinic Recruiting
Toronto, Ontario, Canada, M5G1K2
Contact    4164657936      
Canada, Quebec
Research Institute of the MUHC-Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2X2P4
Contact    514-934-1934 ext 32537      
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Moupali Das, MD, MPH Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02071082     History of Changes
Other Study ID Numbers: GS-US-292-1249
Study First Received: February 21, 2014
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Gilead Sciences:
HIV
HBV
Coinfection

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Tenofovir
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 26, 2014