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Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

18 de febrero de 2020 actualizado por: Gilead Sciences

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

252

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Clinical Research Infectious Diseases Department- Alfred Hospital
      • Prahran, Victoria, Australia, 3181
        • Prahran Market Clinic
  • España
      • Barcelona, España, 8907
        • Hospital Universitari de Bellvitge
      • Barcelona, España, 8916
        • Germans Trias i Pujol University Hospital
      • Madrid, España, 28046
        • Hospital La Paz
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85015
        • Pueblo Family Physicians
      • Phoenix, Arizona, Estados Unidos, 85006
        • Maricopa Integrated Health System - McDowell Clinic
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72207
        • Health For Life Clinic Pllc
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Pacific Oaks Medical Group
      • Hayward, California, Estados Unidos, 94545
        • Kaiser Permanente
      • Long Beach, California, Estados Unidos, 90813
        • Long Beach Education and Research Consultants
      • Los Angeles, California, Estados Unidos, 90069
        • Anthony Mills MD, Inc
      • Los Angeles, California, Estados Unidos, 90036
        • Peter J Ruane, MD, Inc
      • Los Angeles, California, Estados Unidos, 90028
        • LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic
      • Palm Springs, California, Estados Unidos, 92262
        • Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group
      • Sacramento, California, Estados Unidos, 95825
        • Kaiser Permanente Medical Group
      • San Francisco, California, Estados Unidos, 94109
        • Metropolis Medical
      • San Francisco, California, Estados Unidos, 94118
        • Kaiser Permanente CTU San Francisco
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado
      • Denver, Colorado, Estados Unidos, 80206
        • National Jewish Health
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20009
        • Dupont Circle Physician's Group
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33316
        • Gary J. Richmond, MD PA
      • Fort Pierce, Florida, Estados Unidos, 34982
        • Midway Immunology and Research Center
      • Orlando, Florida, Estados Unidos, 32806
        • Idocf/Valuhealthmd
      • Tampa, Florida, Estados Unidos, 33602
        • University of South Florida
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Triple O Research Institute, P.A.
      • Wilton Manors, Florida, Estados Unidos, 33305
        • Rowan Tree Medical, P.A.
    • Georgia
      • Decatur, Georgia, Estados Unidos, 30033
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, Estados Unidos, 31210
        • Mercer University
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Community Research Initiative of New England
      • Springfield, Massachusetts, Estados Unidos, 01105
        • The Research Institute
    • Michigan
      • Berkley, Michigan, Estados Unidos, 48210
        • Be Well Medical Center, P.C.
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55415
        • Hennepin County Medical Center
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • The Kansas City Care Clinic (KC Free Health Clinic)
      • Saint Louis, Missouri, Estados Unidos, 63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Neptune, New Jersey, Estados Unidos, 07754
        • Jersey Shore University Medical Center
      • Newark, New Jersey, Estados Unidos, 07102
        • Saint Michael's Medical Center
    • New Mexico
      • Santa Fe, New Mexico, Estados Unidos, 87505
        • Southwest CARE Center
    • New York
      • Albany, New York, Estados Unidos, 12208
        • Albany Medical College
      • Albany, New York, Estados Unidos, 12208
        • Upstate Infectious Diseases Associates
      • Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center
      • Bronx, New York, Estados Unidos, 10461
        • Jacobi Medical Center
      • Manhasset, New York, Estados Unidos, 11030
        • North Shore University Hospital/Division of Infectious Diseases
      • Rochester, New York, Estados Unidos, 14607
        • Aids Care
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267-0405
        • University of Cincinnati
      • Cleveland, Ohio, Estados Unidos, 44109
        • MetroHealth Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of PA HIV Clinical Trials Unit
    • Texas
      • Bellaire, Texas, Estados Unidos, 77401
        • St. Hope Foundation
      • Dallas, Texas, Estados Unidos, 75246
        • North Texas Infectious Diseases Consultants, PA
      • Harlingen, Texas, Estados Unidos, 78550
        • Garcias' Family Health Group
      • Houston, Texas, Estados Unidos, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, Estados Unidos, 77098
        • Gordon E. Crofoot MD, PA
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Peter Shalit, MD
  • Francia
      • Lyon, Francia, 69004
        • Hôpital de la Croix Rousse
      • Paris, Francia, 75651
        • GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique
  • México
    • Jalisco
      • Guadalajara, Jalisco, México, 44340
        • Hospital Civil de Guadalajara Dr. Juan I. Menchaca
  • Países Bajos
      • Utrecht, Países Bajos, 3584 CX
        • University Medical Center Utrecht
  • Reino Unido
      • Brighton, Reino Unido, BN2 1ES
        • Brighton & Sussex University Hospitals NHS Trust
      • London, Reino Unido, SE5 9RJ
        • Kings College London
      • London, Reino Unido, Sw10 9NH
        • Chelsea and Westminster NHS Foundation Trust Hospital
      • Manchester, Reino Unido, M13 0FH
        • Central Manchester University Hospitals NHS Foundation Trust
  • República Dominicana
      • Santo Domingo, República Dominicana, 99999
        • Instituto Dominicano de Estudios Virologicos (IDEV)
  • Tailandia
      • Bangkok, Tailandia, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
      • Bangkok, Tailandia, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre
      • Bangkok, Tailandia, 10700
        • Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
      • Khon Kaen, Tailandia, 40002
        • Srinagarind Hospital, Khon Kaen University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

Cohort 1 (treatment-experienced switch)

  • Must not have a history of known resistance to elvitegravir (EVG), tenofovir disoproxil fumarate (TDF), or emtricitabine (FTC)
  • Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
  • Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the Cockcroft-Gault formula for creatinine clearance, using actual weight
  • May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that study is complete; or currently receiving Stribild® (STB) or atazanavir (ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that study is complete.

Cohort 2 (treatment-naive)

  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • Screening genotype report provided by Gilead Sciences must show sensitivity to EVG, FTC, and TDF
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis (PEP), up to 6 months prior to screening
  • Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine clearance, using actual weight

All Cohorts:

All individuals must meet all of the following inclusion criteria to be eligible for participation in this study:

  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • CD4+ count of ≥ 50 cells/μL
  • Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening)
  • Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline
  • Normal electrocardiogram (ECG)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Males must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or males must be non-heterosexually active, or practice sexual abstinence

Key Exclusion Criteria:

  • A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening,with the exception of the first two bullet points
  • Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have a documented negative HCV RNA, are eligible
  • Hepatitis B surface antigen (HBVsAg) positive
  • Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone and dexamethasone)
  • Individuals receiving ongoing therapy with any medications not to be used with EVG, COBI, FTC, or TAF or individuals with any known allergies to the excipients of E/C/F/TAF

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: E/C/F/TAF
Participants will receive E/C/F/TAF for 144 weeks. Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.
Droga: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Otros nombres:
  • Genvoya®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Periodo de tiempo: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
Periodo de tiempo: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
Periodo de tiempo: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Baseline; Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Periodo de tiempo: Baseline; Week 2, 4, or 8; Week 24
aGFR was directly measured using iohexol plasma clearance (CLiohexol).
Baseline; Week 2, 4, or 8; Week 24
Percent Change From Baseline in C-type Collagen Sequence (CTX) at Weeks 24 and 48
Periodo de tiempo: Baseline; Weeks 24 and 48
CTX is a biomarker of bone turnover.
Baseline; Weeks 24 and 48
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 24 and 48
Periodo de tiempo: Baseline; Weeks 24 and 48
P1NP is a biomarker of bone turnover.
Baseline; Weeks 24 and 48
Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Periodo de tiempo: Baseline; Weeks 24, 48, 96, and 144
Urine RBP is a renal biomarker which is used to evaluate drug-induced kidney injury.
Baseline; Weeks 24, 48, 96, and 144
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Periodo de tiempo: Baseline; Weeks 24, 48, 96, and 144
Urine beta-2-microglobulin is a renal biomarker which is used to evaluate drug-induced kidney injury.
Baseline; Weeks 24, 48, 96, and 144
Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities
Periodo de tiempo: Baseline up to Week 240 plus 30 days
Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Baseline up to Week 240 plus 30 days
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144
Periodo de tiempo: Weeks 24, 48, 96, and 144
The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144 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.
Weeks 24, 48, 96, and 144
Pharmacokinetic (PK) Parameter: Cmax of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Tmax of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Clast of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Tlast of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: λz of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: AUCtau of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: t1/2 of TAF
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study
Periodo de tiempo: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Change From Baseline in the eGFR_CG at Weeks 48, 96, and 144
Periodo de tiempo: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood.
Baseline; Weeks 48, 96, and 144
Change From Baseline in eGFR_CKD-EPI,cysC at Weeks 48, 96, and 144
Periodo de tiempo: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
Baseline; Weeks 48, 96, and 144
Change From Baseline in eGFR_CKD-EPI,Creatinine at Weeks 48, 96, and 144
Periodo de tiempo: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Baseline; Weeks 48, 96, and 144

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Gilead Sciences

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de marzo de 2013

Finalización primaria (Actual)

31 de julio de 2014

Finalización del estudio (Actual)

18 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

22 de marzo de 2013

Primero enviado que cumplió con los criterios de control de calidad

22 de marzo de 2013

Publicado por primera vez (Estimar)

26 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

18 de febrero de 2020

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GS-US-292-0112
  • 2013-000516-25 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Marco de tiempo para compartir IPD

18 months after study completion

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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