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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 november 2026 uppdaterad av: Gilead Sciences

En operativt sömlös fas 2/3 randomiserad, öppen, multicenter, aktivt kontrollerad studie för att utvärdera säkerheten och effekten av Bictegravir/Lenacapavir kontra stabil baslinjebehandling hos virologiskt undertryckta personer med HIV-1 på stabila komplexa behandlingsregimer

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).

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

689

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Läkemedel: Lenacapavir

Tablets administered orally without regard to food

Andra namn:
  • GS-6207
Läkemedel: Bictegravir

Tablets administered orally without regard to food

Andra namn:
  • GS-9883
Experimentell: 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.
Läkemedel: Lenacapavir

Tablets administered orally without regard to food

Andra namn:
  • GS-6207
Läkemedel: Bictegravir

Tablets administered orally without regard to food

Andra namn:
  • GS-9883
Aktiv komparator: 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.
Läkemedel: 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
Experimentell: 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.
Läkemedel: BIC/LEN FDC

Tablets administered orally without regard to food

Andra namn:
  • Bixlenvo™
Aktiv komparator: 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.
Läkemedel: 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
Experimentell: 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).
Läkemedel: Lenacapavir

Tablets administered orally without regard to food

Andra namn:
  • GS-6207
Läkemedel: BIC/LEN FDC

Tablets administered orally without regard to food

Andra namn:
  • Bixlenvo™

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gilead Sciences

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 augusti 2022

Primärt slutförande (Faktisk)

29 september 2025

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

5 augusti 2022

Först inskickad som uppfyllde QC-kriterierna

12 augusti 2022

Första postat (Faktisk)

16 augusti 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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