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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studieorter
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Florida
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Ft. Pierce, Florida, Förenta staterna, 34982
- Rekrytering
- Midway Immunology and Research Center
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Texas
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Houston, Texas, Förenta staterna, 77098
- Rekrytering
- The Crofoot Research Center, INC
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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. |
Tablet administered orally
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: Week 24
|
Week 24
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 48
|
Week 48
|
|
|
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Tidsram: Week 12
|
Week 12
|
|
|
Change From Baseline in CD4 Cell Count at Week 24
Tidsram: Week 24
|
Week 24
|
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|
Change From Baseline in CD4 Cell Count at Week 48
Tidsram: Week 48
|
Week 48
|
|
|
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
Tidsram: Week 12
|
Week 12
|
|
|
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
Tidsram: Week 24
|
Week 24
|
|
|
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
Tidsram: Week 48
|
Week 48
|
|
|
Pharmacokinetic (PK) Parameter: Cmax of GS-3242
Tidsram: Up to 48 weeks
|
Cmax is defined as the maximum observed concentration of drug. |
Up to 48 weeks
|
|
PK Parameter: Tmax of GS-3242
Tidsram: 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
Tidsram: 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
Tidsram: Up to 48 weeks
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 48 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Gilead Study Director, Gilead Sciences
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GS-US-782-8079-01
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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