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Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels

21. oktober 2026 opdateret af: Gilead Sciences

A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1

Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).

The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.

The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

125

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Ft. Pierce, Florida, Forenede Stater, 34982
        • Rekruttering
        • Midway Immunology and Research Center
    • Texas
      • Houston, Texas, Forenede Stater, 77098
        • Rekruttering
        • The Crofoot Research Center, INC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  • Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.
  • Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.
  • Negative serum pregnancy test at screening and negative urine test at enrollment.
  • Receiving B/F/TAF for ≥ 6 months prior to screening.
  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months before and at screening.
  • No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports.
  • CD4 ≥ 200 cells/mm^3 at screening

Key Exclusion Criteria:

  • Plans to breastfeed during the study period and 60 days following the last dose of study intervention.
  • History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.
  • Creatinine clearance according to the Cockcroft-Gault formula < 60 mL/min.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Treatment Arm A: B/F/TAF

Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks.

After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Medicin: B/F/TAF

Tablet administered orally

Andre navne:
  • Biktarvy®
Eksperimentel: Treatment Arm B: GS-3242 + LEN

Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks.

After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Medicin: GS-3242

Tablet administered orally

Medicin: Lenacapavir

Tablet administered orally

Andre navne:
  • LEN
Eksperimentel: Treatment Arm C: GS-3242 + LEN

Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks.

After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase.
Medicin: GS-3242

Tablet administered orally

Medicin: Lenacapavir

Tablet administered orally

Andre navne:
  • LEN

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
Tidsramme: Week 24
Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
Tidsramme: Week 12
Week 12
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm
Tidsramme: Week 48
Week 48
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Tidsramme: Week 12
Week 12
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Tidsramme: Week 24
Week 24
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Tidsramme: Week 48
Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Tidsramme: Week 12
Week 12
Change From Baseline in CD4 Cell Count at Week 24
Tidsramme: Week 24
Week 24
Change From Baseline in CD4 Cell Count at Week 48
Tidsramme: Week 48
Week 48
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
Tidsramme: Week 12
Week 12
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
Tidsramme: Week 24
Week 24
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
Tidsramme: Week 48
Week 48
Pharmacokinetic (PK) Parameter: Cmax of GS-3242
Tidsramme: Up to 48 weeks

Cmax is defined as the maximum observed concentration of drug.
Up to 48 weeks
PK Parameter: Tmax of GS-3242
Tidsramme: Up to 48 weeks

Tmax is defined as the time (observed time point) of Cmax.
Up to 48 weeks
PK Parameter: Ctau of GS-3242
Tidsramme: Up to 48 weeks

Ctau is defined as the observed drug concentration at the end of the dosing interval.
Up to 48 weeks
PK Parameter: AUCtau of GS-3242
Tidsramme: Up to 48 weeks

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Up to 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gilead Sciences

Efterforskere

  • Studieleder: Gilead Study Director, Gilead Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. juli 2033

Datoer for studieregistrering

Først indsendt

21. september 2026

Først indsendt, der opfyldte QC-kriterier

21. september 2026

Først opslået (Faktiske)

25. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-782-8079-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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