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

19 oktober 2018 bijgewerkt door: Gilead Sciences

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

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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

79

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network/Toronto General Hospital
      • Toronto, Ontario, Canada, M5G1K2
        • Maple Leaf Research/Maple Leaf Medical Clinic
  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 1628655
        • Center Hospital of the National Center for Global Health and Medicine
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85012
        • Spectrum Medical Group
    • California
      • Beverly Hills, California, Verenigde Staten, 90211
        • AHF Research Center
      • Los Angeles, California, Verenigde Staten, 90036
        • Peter J. Ruane MD, Inc.
      • Los Angeles, California, Verenigde Staten, 90069
        • Anthony Mills MD, Inc
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20009
        • Whitman Walker Health
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33765
        • Barry M. Rodwick MD
      • Fort Lauderdale, Florida, Verenigde Staten, 33316
        • Gary J Richmond M.D.,P.A.
      • Fort Pierce, Florida, Verenigde Staten, 34982
        • Midway Immunology and Research Center
      • Miami Beach, Florida, Verenigde Staten, 33139
        • AIDS Health Foundation/WPA
      • Vero Beach, Florida, Verenigde Staten, 32960
        • AIDS Research and Treatment Center of the Treasure Coast
      • West Palm Beach, Florida, Verenigde Staten, 33401
        • Triple O Research Institute PA
    • Michigan
      • Berkley, Michigan, Verenigde Staten, 48072
        • Be Well Medical Center PC
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64111
        • KC Care Clinic
      • Saint Louis, Missouri, Verenigde Staten, 63139
        • Southampton Healthcare, Inc.
    • New Mexico
      • Santa Fe, New Mexico, Verenigde Staten, 87505
        • Southwest CARE Center
    • Texas
      • Austin, Texas, Verenigde Staten, 78705
        • Central Texas Clinical Research
      • Bellaire, Texas, Verenigde Staten
        • St. Hope Foundation
      • Dallas, Texas, Verenigde Staten, 75246
        • North Texas Infectious Diseases Consultants
      • Houston, Texas, Verenigde Staten, 77004
        • Therapeutic Concepts
      • Houston, Texas, Verenigde Staten, 77098
        • Gordon E. Crofoot MD PA
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Peter Shalit MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Andere namen:
  • Genvoya®
Experimenteel: HIV-suppressed
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
Geneesmiddel: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Andere namen:
  • Genvoya®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Tijdsspanne: 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.
Week 24
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Tijdsspanne: Week 24
The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
Week 24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Tijdsspanne: 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.
Week 48
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Tijdsspanne: Week 48
The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.
Week 48
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
Tijdsspanne: 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.
Baseline; Week 24
Percentage of Participants With Normalized ALT at Week 48
Tijdsspanne: 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.
Baseline; Week 48
Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
Tijdsspanne: Baseline; Week 24
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Baseline; Week 24
Percentage of Participants With Seroconversion to Anti-HBs at Week 48
Tijdsspanne: Baseline; Week 48
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Baseline; Week 48
Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
Tijdsspanne: Baseline; Week 24
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Baseline; Week 24
Percentage of Participants With Seroconversion to Anti-HBe at Week 48
Tijdsspanne: Baseline; Week 48
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Baseline; Week 48
Change From Baseline in FibroTest® Score at Week 24
Tijdsspanne: 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.
Baseline; Week 24
Change From Baseline in FibroTest® Score at Week 48
Tijdsspanne: 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.
Baseline; Week 48

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gilead Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 februari 2014

Primaire voltooiing (Werkelijk)

23 januari 2015

Studie voltooiing (Werkelijk)

26 oktober 2016

Studieregistratiedata

Eerst ingediend

21 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

21 februari 2014

Eerst geplaatst (Schatting)

25 februari 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 november 2018

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2018

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GS-US-292-1249

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

18 months after study completion

IPD-toegangscriteria voor delen

A secured external environment with username, password, and RSA code.

IPD delen Ondersteunend informatietype

  • Leerprotocool
  • Statistisch Analyse Plan (SAP)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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