Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

8. juni 2026 opdateret af: Gilead Sciences

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.

The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

175

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Key Inclusion Criteria:

  • Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL for ≥ 6 months before screening.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
  • No documented 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).

Key Exclusion Criteria:

  • Prior use of, or exposure to GS-3242 or LEN.
  • History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
  • Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Eksperimentel: Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
Medicin: Lenacapavir tablet
Indgives oralt
Andre navne:
  • LEN
Medicin: GS-3242 Tablet
Administered orally
Medicin: GS-3242 Injection
Administered intramuscularly (IM)
Medicin: Lenacapavir Injection
Administered IM
Andre navne:
  • LEN
Eksperimentel: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
Medicin: Lenacapavir tablet
Indgives oralt
Andre navne:
  • LEN
Medicin: GS-3242 Tablet
Administered orally
Medicin: GS-3242 Injection
Administered intramuscularly (IM)
Medicin: Lenacapavir Injection
Administered IM
Andre navne:
  • LEN
Eksperimentel: Part A: Group 3 of B/F/TAF
Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.
Medicin: B/F/TAF
Indgives oralt
Eksperimentel: Part B: Group 4 (Conditional) of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
Medicin: Lenacapavir tablet
Indgives oralt
Andre navne:
  • LEN
Medicin: GS-3242 Tablet
Administered orally
Medicin: GS-3242 Injection
Administered intramuscularly (IM)
Medicin: Lenacapavir Injection
Administered IM
Andre navne:
  • LEN

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Tidsramme: Week 35
Week 35
Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 26
Week 26

Sekundære resultatmål

Resultatmål
Tidsramme
Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 52
Week 52
Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 35
Week 35
Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 52
Week 52
Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35
Tidsramme: Baseline, Week 35
Baseline, Week 35
Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52
Tidsramme: Baseline, Week 52
Baseline, Week 52
Part B: Proportion of Participants Wth HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Tidsramme: Week 26
Week 26
Part B: Change From Baseline in CD4 Cell Count at Week 26
Tidsramme: Baseline, Week 26
Baseline, Week 26
Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35
Tidsramme: Up to Week 35
Up to Week 35
Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52
Tidsramme: Up to Week 52
Up to Week 52
Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Tidsramme: Up to Week 26
Up to Week 26
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18
Tidsramme: Week 18
Week 18
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35
Tidsramme: Week 35
Week 35
Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52
Tidsramme: Week 52
Week 52
Part B: Trough Concentrations at GS-3242 and LEN at Week 26
Tidsramme: Week 26
Week 26

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

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 (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. april 2033

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-643-7710

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-1-infektion

Kliniske forsøg med B/F/TAF

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner