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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

2020年2月18日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

252

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
他の名前：
  • ゲンボイヤ®

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Gilead Sciences

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年3月27日

一次修了 (実際)

2014年7月31日

研究の完了 (実際)

2018年7月18日

試験登録日

最初に提出

2013年3月22日

QC基準を満たした最初の提出物

2013年3月22日

最初の投稿 (見積もり)

2013年3月26日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月2日

QC基準を満たした最後の更新が送信されました

2020年2月18日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

18 months after study completion

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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