Study to Compare Bictegravir/Lenacapavir Versus Current T... | NCT05502341

NCT05502341

ID	Type	Description
2022-500929-33	Other Identifier	European Medicines Agency
DOH-27-052023-8574	Other Identifier	South African Clinical Trial Registry
jRCT2051230168	Other Identifier	Japan registry

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg	Experimental	Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).	Drug: Bictegravir Drug: Lenacapavir
Phase 2: BIC 75 mg + LEN 50 mg	Experimental	Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.	Drug: Bictegravir Drug: Lenacapavir
Phase 2: Stable Baseline Regimen (SBR)	Active Comparator	Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.	Drug: Stable Baseline Regimen
Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bictegravir	Drug	Tablets administered orally without regard to food	Phase 2: BIC 75 mg + LEN 50 mg Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm		Week 24
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48

Secondary Outcomes

Measure	Description	Time Frame
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm		Week 24
Phase 2: Change From Baseline in CD4 Cell Count at Week 24		Baseline, Week 24

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Be Well Medical Center		Berkeley	California	48072	United States
Pacific Oaks Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41763229	Derived	Orkin C, Ruane PJ, Hedgcock M, Gaultier C, Losso MH, Trottier B, Lutz T, O'Reilly M, Bloch M, Slim J, Ramgopal M, Sokhela S, Mounzer K, Tsai HC, Santana Bagur J, Zhang X, Aizen K, Price K, Margot N, Montezuma-Rusca JM, Sklar P, Rhee M, Cahn P; ARTISTRY-1 Study Group. Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. Lancet. 2026 Mar 28;407(10535):1249-1258. doi: 10.1016/S0140-6736(26)00307-7. Epub 2026 Feb 25.
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