- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M5G 2N2
- University Health Network/Toronto General Hospital
-
Toronto, Ontario, Canadá, M5G1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
-
-
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85012
- Spectrum Medical Group
-
-
California
-
Beverly Hills, California, Estados Unidos, 90211
- AHF Research Center
-
Los Angeles, California, Estados Unidos, 90036
- Peter J. Ruane MD, Inc.
-
Los Angeles, California, Estados Unidos, 90069
- Anthony Mills MD, Inc
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20009
- Whitman Walker Health
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33765
- Barry M. Rodwick MD
-
Fort Lauderdale, Florida, Estados Unidos, 33316
- Gary J Richmond M.D.,P.A.
-
Fort Pierce, Florida, Estados Unidos, 34982
- Midway Immunology and Research Center
-
Miami Beach, Florida, Estados Unidos, 33139
- AIDS Health Foundation/WPA
-
Vero Beach, Florida, Estados Unidos, 32960
- AIDS Research and Treatment Center of the Treasure Coast
-
West Palm Beach, Florida, Estados Unidos, 33401
- Triple O Research Institute PA
-
-
Michigan
-
Berkley, Michigan, Estados Unidos, 48072
- Be Well Medical Center PC
-
-
Missouri
-
Kansas City, Missouri, Estados Unidos, 64111
- KC Care Clinic
-
Saint Louis, Missouri, Estados Unidos, 63139
- Southampton Healthcare, Inc.
-
-
New Mexico
-
Santa Fe, New Mexico, Estados Unidos, 87505
- Southwest CARE Center
-
-
Texas
-
Austin, Texas, Estados Unidos, 78705
- Central Texas Clinical Research
-
Bellaire, Texas, Estados Unidos
- St. Hope Foundation
-
Dallas, Texas, Estados Unidos, 75246
- North Texas Infectious Diseases Consultants
-
Houston, Texas, Estados Unidos, 77004
- Therapeutic Concepts
-
Houston, Texas, Estados Unidos, 77098
- Gordon E. Crofoot MD PA
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- Peter Shalit MD
-
-
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japón, 1628655
- Center Hospital of the National Center for Global Health and Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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.
|
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Otros nombres:
|
Experimental: HIV-suppressed
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
|
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Periodo de tiempo: 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
Periodo de tiempo: Week 24
|
The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
|
Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Hepatitis
- Hepatitis B
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- Elvitegravir, cobicistat, emtricitabina, tenofovir disoproxil fumarato combinación de fármacos
Otros números de identificación del estudio
- GS-US-292-1249
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre E/C/F/TAF
-
Gilead SciencesTerminadoInfecciones por VIH | VIHEstados Unidos, Reino Unido, Suecia, Francia, Puerto Rico, Países Bajos, Italia, Portugal, Canadá, México, República Dominicana
-
Gilead SciencesTerminadoInfecciones por VIH | VIHEstados Unidos, España, Suiza, Canadá, Tailandia, Puerto Rico, Australia, Austria, Bélgica, Italia, Japón, Reino Unido
-
Gilead SciencesTerminadoInfecciones por VIH | Síndrome de inmunodeficiencia adquiridaEstados Unidos, Puerto Rico
-
Janssen Scientific Affairs, LLCTerminado
-
Gilead SciencesReclutamientoInfección por VIH-1Estados Unidos, Tailandia, Uganda, Sudáfrica
-
Gilead SciencesAún no reclutando
-
Janssen Pharmaceutica N.V., BelgiumTerminado
-
Gilead SciencesActivo, no reclutandoInfecciones por VIH | Síndrome de Inmunodeficiencia Adquirida (SIDA)Estados Unidos, Tailandia, Uganda, Sudáfrica, Zimbabue
-
Janssen-Cilag S.p.A.TerminadoVirus de inmunodeficiencia humana (VIH)Italia
-
Gilead SciencesTerminadoInfección por VIH-1Estados Unidos, Francia, Austria, Alemania