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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

一项操作无缝的 2/3 期随机、开放标签、多中心、主动对照研究，以评估 Bictegravir/Lenacapavir 与稳定基线方案在病毒学抑制的 HIV-1 稳定复杂治疗方案中的安全性和有效性

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).

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

689

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Decarie Montreal、加拿大、H4A 3J1
        • Chronic Viral Illness Service / McGill University Health Centre (MUHC)
      • Montreal、加拿大、H2L 0B1
        • Clinique Medicale du Quartier Latin
      • Ottawa、加拿大、K1H 8L6
        • The Ottawa Hospital - General Campus
      • Regina、加拿大、S4P 0W5
        • ID Clinic
      • Toronto、加拿大、M5G 1K2
        • Maple Leaf Research
      • Vancouver、加拿大、V6Z 2T1
        • Spectrum Health
  • 南非
      • Cape Town、南非、7925
        • Desmond Tutu Health Foundation Clinical Trials Unit
      • Ga-Rankuwa、南非、208
        • Sefako Makgatho Health Sciences University
      • Johannesburg、南非、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
  • 多明尼加共和国
      • Santo Domingo、多明尼加共和国
        • Instituto Dominicano de Estudio Virologicos - IDEV
  • 德国
      • Berlin、德国、10439
        • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
      • Bonn、德国、53127
        • Universitatsklinikum Bonn
      • Frankfurt、德国、60596
        • Infektio Research GmbH & Co.KG
      • Hamburg、德国、20146
        • ICH Study Center GmbH & Co. KG
      • München、德国
        • MVZ München am Goetheplatz
  • 意大利
      • Milan、意大利、20157
        • ASST Fatebenefratelli Sacco
      • Milan、意大利、20127
        • IRCCS Ospedale San Raffaele
      • Modena、意大利、40124
        • Azienda Ospedaliero-Universitaria di Modena
      • Roma、意大利、00149
        • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Torino、意大利、10149
        • ASL Città di Torino
  • 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
  • 法国
      • Nice、法国、6202
        • CHU Nice-Hôpital l'Archet
      • Paris、法国、75010
        • Hospital Saint Louis
      • Paris、法国、75018
        • Groupe Hospitalier Bichat Claude Bernard
      • Paris、法国、75651
        • Höpital de la Pitié Salpêtrière
  • 波多黎各
    • PR
      • San Juan、PR、波多黎各、00909
        • Hope Clinical Research
      • San Juan、PR、波多黎各、00935
        • Proyecto ACTU
  • 澳大利亚
    • New South Wales
      • Darlinghurst、New South Wales、澳大利亚、2010
        • St.Vincent's Hospital Sydney
      • Darlinghurst、New South Wales、澳大利亚、2011
        • Taylor Square Private Clinic
      • Sydney、New South Wales、澳大利亚、2010
        • Holdsworth House Medical Practice
    • Victoria
      • Melbourne、Victoria、澳大利亚、3004
        • Alfred Health
  • 美国
    • California
      • Berkeley、California、美国、48072
        • Be Well Medical Center
      • Beverly Hills、California、美国、90211
        • Pacific Oaks Medical Group
      • Los Angeles、California、美国、90036
        • Ruane Clinical Research Group, Inc
      • Oakland、California、美国、94609
        • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
      • Palm Springs、California、美国、92262
        • Bios Clinical Research
      • San Diego、California、美国、92103
        • University of California San Diego (UCSD)
      • Torrance、California、美国、90502
        • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
      • West Hollywood、California、美国、90046
        • The Men's Health Foundation
    • Colorado
      • Denver、Colorado、美国、80204
        • Denver Health Medical Center
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University; School of Medicine; AIDS Program
    • Florida
      • DeLand、Florida、美国、32720
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale、Florida、美国、33316
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale、Florida、美国、33308
        • Therafirst Medical Centers
      • Ft. Pierce、Florida、美国、34982
        • Midway Immunology & Research Center, LLC
      • Miami、Florida、美国、33136
        • Schiff Center for liver Diseases/University of Miami
      • Miami Lakes、Florida、美国、33016
        • Floridian Clinical Research
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
      • Orlando、Florida、美国、32803
        • Therapeutic Concepts, PA
      • West Palm Beach、Florida、美国、33407
        • Triple O Research Institute PA
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Atlanta ID Group
      • Macon、Georgia、美国、31201
        • Mercer University School of Medicine
    • Illinois
      • Chicago、Illinois、美国、60613
        • Howard Brown Health Center
    • Missouri
      • Kansas City、Missouri、美国、64111
        • Kansas City Care Clinic
      • St Louis、Missouri、美国、63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Newark、New Jersey、美国、07102
        • Saint Michael's Medical Center
    • New Mexico
      • Santa Fe、New Mexico、美国、87505
        • AXCES Research Group
    • New York
      • Flushing、New York、美国、11355
        • New York Presbyterian Hospital
      • New York、New York、美国、10001
        • Ricky K. Hsu, MD, PC
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • University of North Carolina - Chapel Hill
      • Greenville、North Carolina、美国、27858
        • East Carolina University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Philadelphia FIGHT
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina (MUSC) Research NEXUS
    • Texas
      • Austin、Texas、美国、78705
        • Central Texas Clinical Research
      • Bellaire、Texas、美国、77401
        • St. Hope Foundation
      • Dallas、Texas、美国、75246
        • North Texas Infectious Diseases Consultants
      • Dallas、Texas、美国、75208
        • AIDS Arms, Inc., DBA Prism Health North Texas
      • Fort Worth、Texas、美国、76104
        • Texas Centers for Infectious Disease Associates
      • Houston、Texas、美国、77098
        • Gordon E. Crofoot MD PA
      • Longview、Texas、美国、75605
        • Diagnostic Clinic of Longview - Center for Clinical Research
    • Washington
      • Seattle、Washington、美国、98104
        • Peter Shalit, MD
  • 英国
      • Birmingham、英国、B9 5SS
        • Department of HIV & Sexual Medicine
      • Brighton、英国、BN2 3EW
        • Brighton and Sussex University Hospitals NHS Trust
      • London、英国、E1 1BB.
        • Barts Health NHS Trust
      • London、英国、SE5 9RS
        • HIV medicine and infectious diseases
      • London、英国、SW109NH
        • St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
  • 西班牙
      • Barcelona、西班牙、08036
        • Hospital Clinic Provincial de Barcelona
      • Madrid、西班牙、28040
        • Hospital Clinico San Carlos
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
      • Madrid、西班牙、28034
        • Hospital Ramon y Cajal, Madrid
      • Seville、西班牙、4103
        • Hospital Universitario Virgen del Rocio
  • 阿根廷
      • Buenos Aires、阿根廷、1202
        • Fundación Huésped
      • Buenos Aires、阿根廷、1072
        • Hospital General de Agudos J.M Ramon Mejia
      • Buenos Aires、阿根廷、1425
        • Helios Salud
  • 韩国
      • Daegu、韩国、41944
        • Kyungpook National University Hospital
      • Daejeon、韩国、35015
        • Chungnam National University Hospital
      • Seoul、韩国、06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul、韩国、03722
        • Yonsei University Severance Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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)
药品：Lenacapavir

Tablets administered orally without regard to food

其他名称：
  • GS-6207
药品：Bictegravir

Tablets administered orally without regard to food

其他名称：
  • GS-9883
实验性的：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.
药品：Lenacapavir

Tablets administered orally without regard to food

其他名称：
  • GS-6207
药品：Bictegravir

Tablets administered orally without regard to food

其他名称：
  • GS-9883
有源比较器：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.
药品：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
实验性的：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.
药品：BIC/LEN FDC

Tablets administered orally without regard to food

其他名称：
  • Bixlenvo™
有源比较器：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.
药品：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
实验性的：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).
药品：Lenacapavir

Tablets administered orally without regard to food

其他名称：
  • GS-6207
药品：BIC/LEN FDC

Tablets administered orally without regard to food

其他名称：
  • Bixlenvo™

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
大体时间：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
大体时间：Baseline, Week 24
Baseline, Week 24
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Week 96
Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 144
大体时间：Week 144
Week 144

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gilead Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年8月16日

初级完成 (实际的)

2025年9月29日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2022年8月5日

首先提交符合 QC 标准的

2022年8月12日

首次发布 (实际的)

2022年8月16日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GS-US-621-6289
  • 2022-500929-33 (其他标识符：European Medicines Agency)
  • DOH-27-052023-8574 (其他标识符：South African Clinical Trial Registry)
  • jRCT2051230168 (其他标识符：Japan registry)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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