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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 lutego 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

252

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Inne nazwy:
  • Genvoya®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gilead Sciences

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

27 marca 2013

Zakończenie podstawowe (Rzeczywisty)

31 lipca 2014

Ukończenie studiów (Rzeczywisty)

18 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

22 marca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 marca 2013

Pierwszy wysłany (Oszacować)

26 marca 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 marca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 lutego 2020

Ostatnia weryfikacja

1 czerwca 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

18 months after study completion

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zakażenia wirusem HIV

Badania kliniczne na E/C/F/TAF

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Zambia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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