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Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

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ClinicalTrials.gov Identifier: NCT02071082
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : April 4, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 21, 2014
First Posted Date  ICMJE February 25, 2014
Results First Submitted Date  ICMJE January 21, 2016
Results First Posted Date  ICMJE April 4, 2016
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE February 25, 2014
Actual Primary Completion Date January 23, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL [ Time Frame: Week 24 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
  • Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL [ Time Frame: Week 24 ]
    The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
  • Percentage of participants with plasma HBV DNA levels < 29 copies/mL [ Time Frame: Week 24 ]
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per the FDA snapshot definition [ Time Frame: Week 24 ]
Change History Complete list of historical versions of study NCT02071082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL [ Time Frame: Week 48 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
  • Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL [ Time Frame: Week 48 ]
    The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.
  • Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24 [ Time Frame: Baseline; Week 24 ]
    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
  • Percentage of Participants With Normalized ALT at Week 48 [ Time Frame: Baseline; Week 48 ]
    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
  • Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24 [ Time Frame: Baseline; Week 24 ]
    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
  • Percentage of Participants With Seroconversion to Anti-HBs at Week 48 [ Time Frame: Baseline; Week 48 ]
    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
  • Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24 [ Time Frame: Baseline; Week 24 ]
    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
  • Percentage of Participants With Seroconversion to Anti-HBe at Week 48 [ Time Frame: Baseline; Week 48 ]
    Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
  • Change From Baseline in FibroTest® Score at Week 24 [ Time Frame: Baseline; Week 24 ]
    The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
  • Change From Baseline in FibroTest® Score at Week 48 [ Time Frame: Baseline; Week 48 ]
    The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
  • Percentage of participants with plasma HBV DNA levels < 29 copies/mL [ Time Frame: Week 48 ]
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per FDA snapshot definition [ Time Frame: Week 48 ]
  • Percentage of participants with normalized alanine aminotransferase (ALT) [ Time Frame: Weeks 24 and 48 ]
  • Percentage of participants with seroconversion [ Time Frame: Weeks 24 and 48 ]
  • Change in FibroTest® score [ Time Frame: Baseline to Weeks 24 and 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
Official Title  ICMJE 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
Brief Summary

This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults.

Participants will be enrolled into two cohorts:

  • Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive
  • Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • HBV
Intervention  ICMJE Drug: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Other Name: Genvoya®
Study Arms  ICMJE
  • Experimental: HIV treatment-naive and HBV treatment-naive
    HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks.
    Intervention: Drug: E/C/F/TAF
  • Experimental: HIV-suppressed
    HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
    Intervention: Drug: E/C/F/TAF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
79
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2014)
100
Actual Study Completion Date  ICMJE October 26, 2016
Actual Primary Completion Date January 23, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02071082
Other Study ID Numbers  ICMJE GS-US-292-1249
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP