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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 febbraio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

252

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

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

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:

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.

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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • Genvoya®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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)

27 marzo 2013

Completamento primario (Effettivo)

31 luglio 2014

Completamento dello studio (Effettivo)

18 luglio 2018

Date di iscrizione allo studio

Primo inviato

22 marzo 2013

Primo inviato che soddisfa i criteri di controllo qualità

22 marzo 2013

Primo Inserito (Stima)

26 marzo 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 febbraio 2020

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

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

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

Prove cliniche su Infezioni da HIV

Prove cliniche su E/C/F/TAF

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Togo

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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