- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02071082
Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
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
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto, Ontario, Canada, M5G1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
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Arizona
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Phoenix, Arizona, Forente stater, 85012
- Spectrum Medical Group
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California
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Beverly Hills, California, Forente stater, 90211
- AHF Research Center
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Los Angeles, California, Forente stater, 90036
- Peter J. Ruane MD, Inc.
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Los Angeles, California, Forente stater, 90069
- Anthony Mills MD, Inc
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District of Columbia
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Washington, District of Columbia, Forente stater, 20009
- Whitman Walker Health
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Florida
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Clearwater, Florida, Forente stater, 33765
- Barry M. Rodwick MD
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Fort Lauderdale, Florida, Forente stater, 33316
- Gary J Richmond M.D.,P.A.
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Fort Pierce, Florida, Forente stater, 34982
- Midway Immunology and Research Center
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Miami Beach, Florida, Forente stater, 33139
- AIDS Health Foundation/WPA
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Vero Beach, Florida, Forente stater, 32960
- AIDS Research and Treatment Center of the Treasure Coast
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West Palm Beach, Florida, Forente stater, 33401
- Triple O Research Institute PA
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Michigan
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Berkley, Michigan, Forente stater, 48072
- Be Well Medical Center PC
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- KC Care Clinic
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Saint Louis, Missouri, Forente stater, 63139
- Southampton Healthcare, Inc.
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New Mexico
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Santa Fe, New Mexico, Forente stater, 87505
- Southwest CARE Center
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Texas
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Austin, Texas, Forente stater, 78705
- Central Texas Clinical Research
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Bellaire, Texas, Forente stater
- St. Hope Foundation
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Dallas, Texas, Forente stater, 75246
- North Texas Infectious Diseases Consultants
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Houston, Texas, Forente stater, 77004
- Therapeutic Concepts
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Houston, Texas, Forente stater, 77098
- Gordon E. Crofoot MD PA
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Washington
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Seattle, Washington, Forente stater, 98104
- Peter Shalit MD
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 1628655
- Center Hospital of the National Center for Global Health and Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Andre navn:
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Eksperimentell: HIV-suppressed
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Tidsramme: Week 24
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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.
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Week 24
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Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Tidsramme: Week 24
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The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
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Week 24
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Tidsramme: Week 48
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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.
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Week 48
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Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Tidsramme: Week 48
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The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.
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Week 48
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Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
Tidsramme: Baseline; Week 24
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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.
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Baseline; Week 24
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Percentage of Participants With Normalized ALT at Week 48
Tidsramme: Baseline; Week 48
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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.
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Baseline; Week 48
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Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
Tidsramme: Baseline; Week 24
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 24
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Percentage of Participants With Seroconversion to Anti-HBs at Week 48
Tidsramme: Baseline; Week 48
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 48
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Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
Tidsramme: Baseline; Week 24
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 24
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Percentage of Participants With Seroconversion to Anti-HBe at Week 48
Tidsramme: Baseline; Week 48
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 48
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Change From Baseline in FibroTest® Score at Week 24
Tidsramme: Baseline; Week 24
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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.
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Baseline; Week 24
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Change From Baseline in FibroTest® Score at Week 48
Tidsramme: Baseline; Week 48
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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.
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Baseline; Week 48
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Hepatitt, viral, menneskelig
- Hepadnaviridae-infeksjoner
- DNA-virusinfeksjoner
- Hepatitt
- Hepatitt B
- Anti-infeksjonsmidler
- Antivirale midler
- Anti-HIV-midler
- Antiretrovirale midler
- Elvitegravir, Cobicistat, Emtricitabin, Tenofovir Disoproxil Fumarate Legemiddelkombinasjon
Andre studie-ID-numre
- GS-US-292-1249
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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