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

19 ottobre 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

79

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Altri nomi:
  • Genvoya®
Sperimentale: HIV-suppressed
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
Droga: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Altri nomi:
  • Genvoya®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Lasso di tempo: 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
Lasso di tempo: Week 24
The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 febbraio 2014

Completamento primario (Effettivo)

23 gennaio 2015

Completamento dello studio (Effettivo)

26 ottobre 2016

Date di iscrizione allo studio

Primo inviato

21 febbraio 2014

Primo inviato che soddisfa i criteri di controllo qualità

21 febbraio 2014

Primo Inserito (Stima)

25 febbraio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 novembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 ottobre 2018

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GS-US-292-1249

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

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.

Periodo di condivisione IPD

18 months after study completion

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • Protocollo di studio
  • Piano di analisi statistica (SAP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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