Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studiesteder
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Florida
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Ft. Pierce, Florida, Forente stater, 34982
- Rekruttering
- Midway Immunology and Research Center
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Texas
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Houston, Texas, Forente stater, 77098
- Rekruttering
- The Crofoot Research Center, INC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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. |
Tablet administered orally
Andre navn:
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Eksperimentell: 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. |
Tablet administered orally Tablet administered orally
Andre navn:
|
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Eksperimentell: 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. |
Tablet administered orally Tablet administered orally
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
|
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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
|
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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
|
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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
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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
|
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Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Tidsramme: Week 12
|
Week 12
|
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Change From Baseline in CD4 Cell Count at Week 24
Tidsramme: Week 24
|
Week 24
|
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Change From Baseline in CD4 Cell Count at Week 48
Tidsramme: Week 48
|
Week 48
|
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
Tidsramme: Week 12
|
Week 12
|
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
Tidsramme: Week 24
|
Week 24
|
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
Tidsramme: Week 48
|
Week 48
|
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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
|
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Gilead Study Director, Gilead Sciences
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GS-US-782-8079-01
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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