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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. februar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

252

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Andre navne:
  • Genvoya®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gilead Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. marts 2013

Primær færdiggørelse (Faktiske)

31. juli 2014

Studieafslutning (Faktiske)

18. juli 2018

Datoer for studieregistrering

Først indsendt

22. marts 2013

Først indsendt, der opfyldte QC-kriterier

22. marts 2013

Først opslået (Skøn)

26. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. februar 2020

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

18 months after study completion

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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