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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1) (ARTISTRY-1)

2026年11月4日 更新者：Gilead Sciences

ウイルス学的に抑制された HIV-1 患者を対象に、ビクテグラビル / レナカパビルと安定したベースラインレジメンの安全性と有効性を評価するための、操作上シームレスな第 2/3 相無作為化オープンラベル多施設実薬対照試験

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

689

段階

  • フェーズ2
  • 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
    • California
      • Berkeley、California、アメリカ、48072
        • Be Well Medical Center
      • Beverly Hills、California、アメリカ、90211
        • Pacific Oaks Medical Group
      • Los Angeles、California、アメリカ、90036
        • Ruane Clinical Research Group, Inc
      • Oakland、California、アメリカ、94609
        • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
      • Palm Springs、California、アメリカ、92262
        • Bios Clinical Research
      • San Diego、California、アメリカ、92103
        • University of California San Diego (UCSD)
      • Torrance、California、アメリカ、90502
        • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
      • West Hollywood、California、アメリカ、90046
        • The Men's Health Foundation
    • Colorado
      • Denver、Colorado、アメリカ、80204
        • Denver Health Medical Center
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale University; School of Medicine; AIDS Program
    • Florida
      • DeLand、Florida、アメリカ、32720
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale、Florida、アメリカ、33316
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale、Florida、アメリカ、33308
        • Therafirst Medical Centers
      • Ft. Pierce、Florida、アメリカ、34982
        • Midway Immunology & Research Center, LLC
      • Miami、Florida、アメリカ、33136
        • Schiff Center for liver Diseases/University of Miami
      • Miami Lakes、Florida、アメリカ、33016
        • Floridian Clinical Research
      • Orlando、Florida、アメリカ、32803
        • Orlando Immunology Center
      • Orlando、Florida、アメリカ、32803
        • Therapeutic Concepts, PA
      • West Palm Beach、Florida、アメリカ、33407
        • Triple O Research Institute PA
    • Georgia
      • Atlanta、Georgia、アメリカ、30309
        • Atlanta ID Group
      • Macon、Georgia、アメリカ、31201
        • Mercer University School of Medicine
    • Illinois
      • Chicago、Illinois、アメリカ、60613
        • Howard Brown Health Center
    • Missouri
      • Kansas City、Missouri、アメリカ、64111
        • Kansas City Care Clinic
      • St Louis、Missouri、アメリカ、63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Newark、New Jersey、アメリカ、07102
        • Saint Michael's Medical Center
    • New Mexico
      • Santa Fe、New Mexico、アメリカ、87505
        • AXCES Research Group
    • New York
      • Flushing、New York、アメリカ、11355
        • New York Presbyterian Hospital
      • New York、New York、アメリカ、10001
        • Ricky K. Hsu, MD, PC
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27514
        • University of North Carolina - Chapel Hill
      • Greenville、North Carolina、アメリカ、27858
        • East Carolina University
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Philadelphia FIGHT
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Medical University of South Carolina (MUSC) Research NEXUS
    • Texas
      • Austin、Texas、アメリカ、78705
        • Central Texas Clinical Research
      • Bellaire、Texas、アメリカ、77401
        • St. Hope Foundation
      • Dallas、Texas、アメリカ、75246
        • North Texas Infectious Diseases Consultants
      • Dallas、Texas、アメリカ、75208
        • AIDS Arms, Inc., DBA Prism Health North Texas
      • Fort Worth、Texas、アメリカ、76104
        • Texas Centers for Infectious Disease Associates
      • Houston、Texas、アメリカ、77098
        • Gordon E. Crofoot MD PA
      • Longview、Texas、アメリカ、75605
        • Diagnostic Clinic of Longview - Center for Clinical Research
    • Washington
      • Seattle、Washington、アメリカ、98104
        • Peter Shalit, MD
  • アルゼンチン
      • Buenos Aires、アルゼンチン、1202
        • Fundación Huésped
      • Buenos Aires、アルゼンチン、1072
        • Hospital General de Agudos J.M Ramon Mejia
      • Buenos Aires、アルゼンチン、1425
        • Helios Salud
  • イギリス
      • Birmingham、イギリス、B9 5SS
        • Department of HIV & Sexual Medicine
      • Brighton、イギリス、BN2 3EW
        • Brighton and Sussex University Hospitals NHS Trust
      • London、イギリス、E1 1BB.
        • Barts Health NHS Trust
      • London、イギリス、SE5 9RS
        • HIV medicine and infectious diseases
      • London、イギリス、SW109NH
        • St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
  • イタリア
      • Milan、イタリア、20157
        • ASST Fatebenefratelli Sacco
      • Milan、イタリア、20127
        • IRCCS Ospedale San Raffaele
      • Modena、イタリア、40124
        • Azienda Ospedaliero-Universitaria di Modena
      • Roma、イタリア、00149
        • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Torino、イタリア、10149
        • ASL Città di Torino
  • オーストラリア
    • New South Wales
      • Darlinghurst、New South Wales、オーストラリア、2010
        • St.Vincent's Hospital Sydney
      • Darlinghurst、New South Wales、オーストラリア、2011
        • Taylor Square Private Clinic
      • Sydney、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
        • Alfred Health
  • カナダ
      • Decarie Montreal、カナダ、H4A 3J1
        • Chronic Viral Illness Service / McGill University Health Centre (MUHC)
      • Montreal、カナダ、H2L 0B1
        • Clinique Medicale du Quartier Latin
      • Ottawa、カナダ、K1H 8L6
        • The Ottawa Hospital - General Campus
      • Regina、カナダ、S4P 0W5
        • ID Clinic
      • Toronto、カナダ、M5G 1K2
        • Maple Leaf Research
      • Vancouver、カナダ、V6Z 2T1
        • Spectrum Health
  • スペイン
      • Barcelona、スペイン、08036
        • Hospital Clinic Provincial de Barcelona
      • Madrid、スペイン、28040
        • Hospital Clinico San Carlos
      • Madrid、スペイン、28046
        • Hospital Universitario La Paz
      • Madrid、スペイン、28034
        • Hospital Ramon y Cajal, Madrid
      • Seville、スペイン、4103
        • Hospital Universitario Virgen del Rocio
  • ドイツ
      • Berlin、ドイツ、10439
        • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
      • Bonn、ドイツ、53127
        • Universitatsklinikum Bonn
      • Frankfurt、ドイツ、60596
        • Infektio Research GmbH & Co.KG
      • Hamburg、ドイツ、20146
        • ICH Study Center GmbH & Co. KG
      • München、ドイツ
        • MVZ München am Goetheplatz
  • ドミニカ共和国
      • Santo Domingo、ドミニカ共和国
        • Instituto Dominicano de Estudio Virologicos - IDEV
  • フランス
      • Nice、フランス、6202
        • CHU Nice-Hôpital l'Archet
      • Paris、フランス、75010
        • Hospital Saint Louis
      • Paris、フランス、75018
        • Groupe Hospitalier Bichat Claude Bernard
      • Paris、フランス、75651
        • Höpital de la Pitié Salpêtrière
  • プエルトリコ
    • PR
      • San Juan、PR、プエルトリコ、00909
        • Hope Clinical Research
      • San Juan、PR、プエルトリコ、00935
        • Proyecto ACTU
  • 南アフリカ
      • Cape Town、南アフリカ、7925
        • Desmond Tutu Health Foundation Clinical Trials Unit
      • Ga-Rankuwa、南アフリカ、208
        • Sefako Makgatho Health Sciences University
      • Johannesburg、南アフリカ、2193
        • Ezintsha
  • 台湾
      • Kaohsiung City、台湾、80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City、台湾、81362
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City、台湾、22060
        • Far Eastern Memorial Hospital
      • Taoyuan City、台湾、33004
        • Taoyuan General Hospital
  • 日本
      • Nagoya、日本
        • National Hospital Organization Nagoya Medical Center
      • Osaka、日本、540-0006
        • National Hospital Organization Osaka National Hospital
      • Tokyo、日本、162-0052
        • Center Hospital of the National Center for Global Health and Medicine
  • 韓国
      • Daegu、韓国、41944
        • Kyungpook National University Hospital
      • Daejeon、韓国、35015
        • Chungnam National University Hospital
      • Seoul、韓国、06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul、韓国、03722
        • Yonsei University Severance Hospital

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:

  • If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL.

  • At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL

  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.

  • Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:

    • A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
    • A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
    • A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.

  • No documented or suspected resistance to bictegravir (BIC).

  • Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Key Exclusion Criteria:

  • Prior use of, or exposure to, lenacapavir (LEN)
  • Active tuberculosis infection
  • Chronic hepatitis B virus (HBV) infection

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：ランダム化
  • 介入モデル：並列代入
  • 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：Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg

Participants will switch from their Stable Baseline Regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day pharmacokinetic (PK) oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1.

Participants who discontinue early or complete the Randomized Phase (RP) will have an option to continue in Extension Period (EP)
薬：Lenacapavir

Tablets administered orally without regard to food

他の名前：
  • GS-6207
薬：Bictegravir

Tablets administered orally without regard to food

他の名前：
  • GS-9883
実験的：Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg

Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1.

Participants who discontinue early or complete the RP will have an option to continue in EP.
薬：Lenacapavir

Tablets administered orally without regard to food

他の名前：
  • GS-6207
薬：Bictegravir

Tablets administered orally without regard to food

他の名前：
  • GS-9883
アクティブコンパレータ：Phase 2: Treatment Group 3: SBR

Participants will continue with their SBR for up to 24 weeks.

Participants who discontinue early or complete the RP will have an option to continue in EP.
薬：Stable Baseline Regimen

SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).

  • Nucleos(t)ide Reverse Transcriptase Inhibitors:

    • Abacavir
    • Emtricitabine
    • Lamivudine
    • Tenofovir alafenamide
    • Tenofovir disoproxil fumarate
    • Zidovudine

  • Non-Nucleosite Reverse Transcriptase Inhibitors:

    • Delavirdine
    • Efavirenz
    • Nevirapine
    • Rilpivirine
    • Doravirine

  • Integrase Inhibitors:

    • Bictegravir
    • Cabotegravir
    • Dolutegravir
    • Elvitegravir
    • Raltegravir

  • Protease Inhibitors:

    • Atazanavir
    • Darunavir
    • Fosamprenavir
    • Indinavir
    • Lopinavir
    • Nelfinavir
    • Saquinavir
    • Tipranavir

  • Chemokine Co-receptor 5 (CCR5) Antagonist:

    • Maraviroc

  • Fusion Inhibitors:

    • Enfuvirtide

  • gp120 Attachment Inhibitor:

    • Fostemsavir

  • Anti-CD4 Monoclonal Antibodies:

    • Ibalizumab-uiyk
実験的：Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC

Participants will switch from their SBR to a regimen of BIC/LEN 75mg/50mg FDC, administered orally once daily for up to 48 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1.

Participants who discontinue early or complete the RP will have an option to continue in EP.
薬：BIC/LEN FDC

Tablets administered orally without regard to food

他の名前：
  • Bixlenvo™
アクティブコンパレータ：Phase 3: Treatment Group 2: SBR

Participants will continue with their SBR for up to 48 weeks.

Participants who will discontinue early or complete the RP had an option to continue in EP.
薬：Stable Baseline Regimen

SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).

  • Nucleos(t)ide Reverse Transcriptase Inhibitors:

    • Abacavir
    • Emtricitabine
    • Lamivudine
    • Tenofovir alafenamide
    • Tenofovir disoproxil fumarate
    • Zidovudine

  • Non-Nucleosite Reverse Transcriptase Inhibitors:

    • Delavirdine
    • Efavirenz
    • Nevirapine
    • Rilpivirine
    • Doravirine

  • Integrase Inhibitors:

    • Bictegravir
    • Cabotegravir
    • Dolutegravir
    • Elvitegravir
    • Raltegravir

  • Protease Inhibitors:

    • Atazanavir
    • Darunavir
    • Fosamprenavir
    • Indinavir
    • Lopinavir
    • Nelfinavir
    • Saquinavir
    • Tipranavir

  • Chemokine Co-receptor 5 (CCR5) Antagonist:

    • Maraviroc

  • Fusion Inhibitors:

    • Enfuvirtide

  • gp120 Attachment Inhibitor:

    • Fostemsavir

  • Anti-CD4 Monoclonal Antibodies:

    • Ibalizumab-uiyk
実験的：Phase 2/Phase 3:BIC/LEN 75/50 mg FDC

At the end of randomized treatment, participants in Phase 2 and Phase 3 treatment groups who discontinue early or complete the RP will be given an option to enter in EP and will receive BIC/LEN 75/50 mg FDC until the drug is available in market or Gilead elects to withdraw the study. Participants in the SBR groups (Phase 2 Treatment Group 3 and Phase 3 Treatment Group 2 will also receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2 of EP).
薬：Lenacapavir

Tablets administered orally without regard to food

他の名前：
  • GS-6207
薬：BIC/LEN FDC

Tablets administered orally without regard to food

他の名前：
  • Bixlenvo™

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
Phase 2: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 24 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm
時間枠：Week 24

Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the week 24 analysis window, or who did not have on-treatment HIV-1 RNA data in the week 24 analysis window and participants who discontinued study drug prior to or in the week 24 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the week 24 analysis window due to adverse event (AE) or death and have the last available on-treatment HIV-1 RNA≥ 50 copies/mL, or who discontinued study drug prior to or in the week 24 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 24 window for snapshot algorithm was between Days 127 and 210 (inclusively). Percentages were rounded off.
Week 24
Phase 3: Percentages of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 48

Participants who had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to AE or death and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.
Week 48

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 24

Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 24 analysis window were included. The Week 24 window for snapshot algorithm was between Days 127 and 210 (inclusively). Percentages were rounded off.
Week 24
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24
時間枠：Baseline, Week 24
Baseline, Week 24
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24
時間枠：First dose date up to Week 24

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC+LEN or BIC/LEN FDC) or 30 days (for SBR) or any AE leading to study drug discontinuation. Percentages were rounded off.
First dose date up to Week 24
Phase 2: PK Parameter: Cmax for Bictegravir (BIC) at Steady State
時間枠：At Week 16 or 24

Cmax is defined as the maximum observed concentration of drug. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or 24
Phase 2: PK Parameter: Cmax for Lenacapavir (LEN) at Steady State
時間枠：At Week 16 or Week 24

Cmax is defined as the maximum observed concentration of drug. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or Week 24
Phase 2: PK Parameter: AUCtau of BIC at Steady State
時間枠：At Week 16 or 24

AUCtau is defined as the area under the concentration versus time curve over the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or 24
Phase 2: PK Parameter: AUCtau for LEN at Steady State
時間枠：At Week 16 or Week 24

AUCtau is defined as the area under the concentration versus time curve over the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or Week 24
Phase 2: PK Parameter: Ctrough of BIC at Steady State
時間枠：At Week 16 or Week 24

Ctrough is defined as the observed drug concentration at the end of the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or Week 24
Phase 2: PK Parameter: Ctrough of LEN at Steady State
時間枠：At Week 16 or Week 24

Ctrough is defined as the observed drug concentration at the end of the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
At Week 16 or Week 24
Phase 3: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 48

Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 48 analysis window were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively).
Week 48
Phase 3: Change From Baseline in CD4 Cell Count at Week 48
時間枠：Baseline, Week 48

An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC+LEN or BIC/LEN FDC) or 30 days (for SBR) or any AE leading to study drug discontinuation. Percentages were rounded off.
Baseline, Week 48
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48
時間枠：First dose date up to Week 48

An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as 1 or both of the following: Any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off.
First dose date up to Week 48
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 96
Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 144
Week 144
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 96
Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 144
Week 144
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96
時間枠：Baseline, Week 96
Baseline, Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 144
時間枠：Baseline, Week 144
Baseline, Week 144
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 96
時間枠：Week 96
Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 144
時間枠：Week 144
Week 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

便利なリンク

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)

2022年8月16日

一次修了 (実際)

2025年9月29日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2022年8月5日

QC基準を満たした最初の提出物

2022年8月12日

最初の投稿 (実際)

2022年8月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GS-US-621-6289
  • 2022-500929-33 (その他の識別子：European Medicines Agency)
  • DOH-27-052023-8574 (その他の識別子：South African Clinical Trial Registry)
  • jRCT2051230168 (その他の識別子：Japan registry)

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?

いいえ

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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