A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
3. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
175
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studiesteder
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New South Wales
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Surry Hills, New South Wales, Australia, 2010
- Rekruttering
- Taylor Square Private Clinic
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Sydney, New South Wales, Australia, 2010 NSW
- Rekruttering
- Momentum Clinical Research Darlinghurst
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Sydney, New South Wales, Australia, 2010
- Rekruttering
- East Sydney Doctors
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Victoria
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South Yarra, Victoria, Australia, 3141
- Rekruttering
- Prahran Market Clinic,
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Montreal, Canada, H2L 5B1
- Rekruttering
- CMU du Quartier Latin
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Vancouver, Canada, V6Z2T1
- Aktiv, ikke rekrutterende
- Spectrum Health
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Rekruttering
- McGill University Health Centre
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Arizona
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Phoenix, Arizona, Forente stater, 85015
- Aktiv, ikke rekrutterende
- Pueblo Family Physicians
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California
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Beverly Hills, California, Forente stater, 90211
- Rekruttering
- Pacific Oak Medical Group
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Los Angeles, California, Forente stater, 90036
- Aktiv, ikke rekrutterende
- Ruane Clinical Research Group Inc.
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San Francisco, California, Forente stater, 94102
- Rekruttering
- Optimus Medical Group
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San Francisco, California, Forente stater, 94110
- Rekruttering
- University of California San Francisco, Community and Clinical Research Center
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Torrance, California, Forente stater, 90502
- Rekruttering
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80246
- Rekruttering
- Vivent Health
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Florida
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DeLand, Florida, Forente stater, 32720
- Rekruttering
- Midland Florida Clinical Research Center, LLC
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Fort Lauderdale, Florida, Forente stater, 33316
- Rekruttering
- CAN Community Health Fort Lauderdale
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Ft. Pierce, Florida, Forente stater, 34982
- Rekruttering
- Midway Immunology and Research Center
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Miami, Florida, Forente stater, 33133
- Rekruttering
- AIDS Healthcare Foundation -Coconut Grove
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Miami Lakes, Florida, Forente stater, 33016
- Rekruttering
- Floridian Clinical Research, LLC
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Orlanda, Florida, Forente stater, 32803
- Rekruttering
- Orlando Immunology Center, PA
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Pensacola, Florida, Forente stater, 32504
- Rekruttering
- AHF - Pensacola
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Sarasota, Florida, Forente stater, 34237
- Rekruttering
- CAN Community Health Inc.
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West Palm Beach, Florida, Forente stater, 33407
- Rekruttering
- Triple O Research Institute, PA
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Rekruttering
- Emory University Hospital Midtown Infectious Disease Clinic
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Decatur, Georgia, Forente stater, 30033
- Rekruttering
- Metro Infectious Disease Consultants, P.L.L.C.
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Macon, Georgia, Forente stater, 31201
- Rekruttering
- Mercer University, Department of Internal Medicine
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Savannah, Georgia, Forente stater, 31401
- Rekruttering
- Chatham County Health Department
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Michigan
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Berkeley, Michigan, Forente stater, 48072
- Rekruttering
- Be Well Medical Center
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- Rekruttering
- KC Care Health Center
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St Louis, Missouri, Forente stater, 63139
- Rekruttering
- Southampton Community Healthcare
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New Jersey
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Hillsborough, New Jersey, Forente stater, 08844
- Rekruttering
- ID care
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Newark, New Jersey, Forente stater, 07102
- Rekruttering
- Saint Michael's Medical Center
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Somers Point, New Jersey, Forente stater, 08244
- Rekruttering
- South Jersey Infectious Disease
-
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New Mexico
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Sante Fe, New Mexico, Forente stater, 87505
- Rekruttering
- AXCES Research Group, LLC
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New York
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Brooklyn, New York, Forente stater, 11226
- Rekruttering
- Brooklyn Clinical Research
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Flushing, New York, Forente stater, 11355
- Rekruttering
- NewYork-Presbyterian Queens
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New York, New York, Forente stater, 10016
- Rekruttering
- NYU Langone Health Vaccine Center
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The Bronx, New York, Forente stater, 10467
- Aktiv, ikke rekrutterende
- Montefiore Medical Center
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North Carolina
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Huntersville, North Carolina, Forente stater, 28078
- Rekruttering
- Rosedale Health and Wellness
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
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Texas
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Austin, Texas, Forente stater, 78705
- Rekruttering
- Central Texas Clinical Research
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Bellaire, Texas, Forente stater, 77401
- Rekruttering
- St. Hope Foundation
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Dallas, Texas, Forente stater, 75208
- Rekruttering
- Prism Health North Texas
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- North Texas Infectious Disease Consultants, P.A.
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El Paso, Texas, Forente stater, 79902
- Rekruttering
- AXCES Research Group, LLC
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Fort Worth, Texas, Forente stater, 76109
- Aktiv, ikke rekrutterende
- Texas Centers for Infectious Disease Associates
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Houston, Texas, Forente stater, 77098
- Rekruttering
- The Crofoot Research Center, INC.
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Longview, Texas, Forente stater, 75605
- Rekruttering
- Diagnostic Clinic of Longview
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Utah
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Salt Lake City, Utah, Forente stater, 84102
- Rekruttering
- AXCES Research Group, LLC
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Virginia
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Annandale, Virginia, Forente stater, 22003
- Rekruttering
- Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- TribalMed PLLC
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Spokane, Washington, Forente stater, 99202
- Aktiv, ikke rekrutterende
- MultiCare-Deaconess Medical Office Building 2
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PR
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Rio Piedras, PR, Puerto Rico, 00925
- Rekruttering
- Proyecto ACTU
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San Juan, PR, Puerto Rico, 00909
- Rekruttering
- Clinical Research Puerto Rico
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San Juan, PR, Puerto Rico, 00909
- Rekruttering
- Hope Clinical Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Administrert oralt
Andre navn:
Administered orally
Administered intramuscularly (IM)
Administered IM
Andre navn:
|
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Eksperimentell: 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.
|
Administrert oralt
Andre navn:
Administered orally
Administered intramuscularly (IM)
Administered IM
Andre navn:
|
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Eksperimentell: 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.
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Administreres oralt
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Eksperimentell: 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.
|
Administrert oralt
Andre navn:
Administered orally
Administered intramuscularly (IM)
Administered IM
Andre navn:
|
Hva måler studien?
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
|
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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
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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
|
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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
|
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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
|
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Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35
Tidsramme: Baseline, Week 35
|
Baseline, Week 35
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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
|
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Part B: Change From Baseline in CD4 Cell Count at Week 26
Tidsramme: Baseline, Week 26
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Baseline, Week 26
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Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35
Tidsramme: Up to Week 35
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Up to Week 35
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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
|
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Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Tidsramme: Up to Week 26
|
Up to Week 26
|
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Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18
Tidsramme: Week 18
|
Week 18
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Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35
Tidsramme: Week 35
|
Week 35
|
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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
|
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Part B: Trough Concentrations at GS-3242 and LEN at Week 26
Tidsramme: Week 26
|
Week 26
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Gilead Study Director, Gilead Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juni 2026
Primær fullføring (Antatt)
1. august 2027
Studiet fullført (Antatt)
1. april 2033
Datoer for studieregistrering
Først innsendt
8. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GS-US-643-7710
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .