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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)

4 de novembro de 2026 atualizado por: Gilead Sciences

Um estudo randomizado, aberto, multicêntrico, controlado por ativo operacionalmente contínuo para avaliar a segurança e a eficácia de Bictegravir/Lenacapavir versus regime de linha de base estável em pessoas com HIV-1 com supressão virológica em regimes de tratamento complexos estáveis

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).

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

689

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10439
        • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
      • Bonn, Alemanha, 53127
        • Universitatsklinikum Bonn
      • Frankfurt, Alemanha, 60596
        • Infektio Research GmbH & Co.KG
      • Hamburg, Alemanha, 20146
        • ICH Study Center GmbH & Co. KG
      • München, Alemanha
        • MVZ München am Goetheplatz
  • Argentina
      • Buenos Aires, Argentina, 1202
        • Fundación Huésped
      • Buenos Aires, Argentina, 1072
        • Hospital General de Agudos J.M Ramon Mejia
      • Buenos Aires, Argentina, 1425
        • Helios Salud
  • Austrália
    • New South Wales
      • Darlinghurst, New South Wales, Austrália, 2010
        • St.Vincent's Hospital Sydney
      • Darlinghurst, New South Wales, Austrália, 2011
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Austrália, 2010
        • Holdsworth House Medical Practice
    • Victoria
      • Melbourne, Victoria, Austrália, 3004
        • Alfred Health
  • Canadá
      • Decarie Montreal, Canadá, H4A 3J1
        • Chronic Viral Illness Service / McGill University Health Centre (MUHC)
      • Montreal, Canadá, H2L 0B1
        • Clinique Medicale du Quartier Latin
      • Ottawa, Canadá, K1H 8L6
        • The Ottawa Hospital - General Campus
      • Regina, Canadá, S4P 0W5
        • ID Clinic
      • Toronto, Canadá, M5G 1K2
        • Maple Leaf Research
      • Vancouver, Canadá, V6Z 2T1
        • Spectrum Health
  • Coréia do Sul
      • Daegu, Coréia do Sul, 41944
        • Kyungpook National University Hospital
      • Daejeon, Coréia do Sul, 35015
        • Chungnam National University Hospital
      • Seoul, Coréia do Sul, 06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul, Coréia do Sul, 03722
        • Yonsei University Severance Hospital
  • Espanha
      • Barcelona, Espanha, 08036
        • Hospital Clinic Provincial de Barcelona
      • Madrid, Espanha, 28040
        • Hospital Clinico San Carlos
      • Madrid, Espanha, 28046
        • Hospital Universitario La Paz
      • Madrid, Espanha, 28034
        • Hospital Ramon y Cajal, Madrid
      • Seville, Espanha, 4103
        • Hospital Universitario Virgen del Rocio
  • Estados Unidos
    • California
      • Berkeley, California, Estados Unidos, 48072
        • Be Well Medical Center
      • Beverly Hills, California, Estados Unidos, 90211
        • Pacific Oaks Medical Group
      • Los Angeles, California, Estados Unidos, 90036
        • Ruane Clinical Research Group, Inc
      • Oakland, California, Estados Unidos, 94609
        • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
      • Palm Springs, California, Estados Unidos, 92262
        • Bios Clinical Research
      • San Diego, California, Estados Unidos, 92103
        • University of California San Diego (UCSD)
      • Torrance, California, Estados Unidos, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
      • West Hollywood, California, Estados Unidos, 90046
        • The Men's Health Foundation
    • Colorado
      • Denver, Colorado, Estados Unidos, 80204
        • Denver Health Medical Center
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale University; School of Medicine; AIDS Program
    • Florida
      • DeLand, Florida, Estados Unidos, 32720
        • Midland Florida Clinical Research Center, LLC
      • Fort Lauderdale, Florida, Estados Unidos, 33316
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Therafirst Medical Centers
      • Ft. Pierce, Florida, Estados Unidos, 34982
        • Midway Immunology & Research Center, LLC
      • Miami, Florida, Estados Unidos, 33136
        • Schiff Center for liver Diseases/University of Miami
      • Miami Lakes, Florida, Estados Unidos, 33016
        • Floridian Clinical Research
      • Orlando, Florida, Estados Unidos, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Estados Unidos, 32803
        • Therapeutic Concepts, PA
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Triple O Research Institute PA
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Atlanta ID Group
      • Macon, Georgia, Estados Unidos, 31201
        • Mercer University School of Medicine
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60613
        • Howard Brown Health Center
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Kansas City Care Clinic
      • St Louis, Missouri, Estados Unidos, 63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Newark, New Jersey, Estados Unidos, 07102
        • Saint Michael's Medical Center
    • New Mexico
      • Santa Fe, New Mexico, Estados Unidos, 87505
        • AXCES Research Group
    • New York
      • Flushing, New York, Estados Unidos, 11355
        • New York Presbyterian Hospital
      • New York, New York, Estados Unidos, 10001
        • Ricky K. Hsu, MD, PC
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27514
        • University of North Carolina - Chapel Hill
      • Greenville, North Carolina, Estados Unidos, 27858
        • East Carolina University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Philadelphia FIGHT
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina (MUSC) Research NEXUS
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Central Texas Clinical Research
      • Bellaire, Texas, Estados Unidos, 77401
        • St. Hope Foundation
      • Dallas, Texas, Estados Unidos, 75246
        • North Texas Infectious Diseases Consultants
      • Dallas, Texas, Estados Unidos, 75208
        • AIDS Arms, Inc., DBA Prism Health North Texas
      • Fort Worth, Texas, Estados Unidos, 76104
        • Texas Centers for Infectious Disease Associates
      • Houston, Texas, Estados Unidos, 77098
        • Gordon E. Crofoot MD PA
      • Longview, Texas, Estados Unidos, 75605
        • Diagnostic Clinic of Longview - Center for Clinical Research
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Peter Shalit, MD
  • França
      • Nice, França, 6202
        • CHU Nice-Hôpital l'Archet
      • Paris, França, 75010
        • Hospital Saint Louis
      • Paris, França, 75018
        • Groupe Hospitalier Bichat Claude Bernard
      • Paris, França, 75651
        • Höpital de la Pitié Salpêtrière
  • Itália
      • Milan, Itália, 20157
        • ASST Fatebenefratelli Sacco
      • Milan, Itália, 20127
        • IRCCS Ospedale San Raffaele
      • Modena, Itália, 40124
        • Azienda Ospedaliero-Universitaria di Modena
      • Roma, Itália, 00149
        • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Torino, Itália, 10149
        • ASL Città di Torino
  • Japão
      • Nagoya, Japão
        • National Hospital Organization Nagoya Medical Center
      • Osaka, Japão, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Tokyo, Japão, 162-0052
        • Center Hospital of the National Center for Global Health and Medicine
  • Porto Rico
    • PR
      • San Juan, PR, Porto Rico, 00909
        • Hope Clinical Research
      • San Juan, PR, Porto Rico, 00935
        • Proyecto ACTU
  • Reino Unido
      • Birmingham, Reino Unido, B9 5SS
        • Department of HIV & Sexual Medicine
      • Brighton, Reino Unido, BN2 3EW
        • Brighton and Sussex University Hospitals NHS Trust
      • London, Reino Unido, E1 1BB.
        • Barts Health NHS Trust
      • London, Reino Unido, SE5 9RS
        • HIV medicine and infectious diseases
      • London, Reino Unido, SW109NH
        • St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
  • República Dominicana
      • Santo Domingo, República Dominicana
        • Instituto Dominicano de Estudio Virologicos - IDEV
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital
      • Taoyuan City, Taiwan, 33004
        • Taoyuan General Hospital
  • África do Sul
      • Cape Town, África do Sul, 7925
        • Desmond Tutu Health Foundation Clinical Trials Unit
      • Ga-Rankuwa, África do Sul, 208
        • Sefako Makgatho Health Sciences University
      • Johannesburg, África do Sul, 2193
        • Ezintsha

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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)
Medicamento: Lenacapavir

Tablets administered orally without regard to food

Outros nomes:
  • GS-6207
Medicamento: Bictegravir

Tablets administered orally without regard to food

Outros nomes:
  • GS-9883
Experimental: 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.
Medicamento: Lenacapavir

Tablets administered orally without regard to food

Outros nomes:
  • GS-6207
Medicamento: Bictegravir

Tablets administered orally without regard to food

Outros nomes:
  • GS-9883
Comparador Ativo: 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.
Medicamento: 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
Experimental: 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.
Medicamento: BIC/LEN FDC

Tablets administered orally without regard to food

Outros nomes:
  • Bixlenvo™
Comparador Ativo: 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.
Medicamento: 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
Experimental: 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).
Medicamento: Lenacapavir

Tablets administered orally without regard to food

Outros nomes:
  • GS-6207
Medicamento: BIC/LEN FDC

Tablets administered orally without regard to food

Outros nomes:
  • Bixlenvo™

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Prazo: 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
Prazo: Baseline, Week 24
Baseline, Week 24
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 96
Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 144
Prazo: Week 144
Week 144

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Gilead Sciences

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de agosto de 2022

Conclusão Primária (Real)

29 de setembro de 2025

Conclusão do estudo (Estimado)

1 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de agosto de 2022

Primeira postagem (Real)

16 de agosto de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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