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A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524336-19-00
Enrollment
10
Registered
2026-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

Brief summary

Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.

Detailed description

Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 92 as defined by the US FDA snapshot algorithm., Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 52 and 92 as determined by the US FDA snapshot algorithm., Changes from baseline in CD4+ T-cell counts at Weeks 52 and 92., Proportion of participants experiencing TEAEs., Proportion of participants prematurely discontinuing their study treatment due to an AE., Trough concentrations at Weeks 26, 52, and 104 for LEN, TAB, and ZAB., Incidence of ADAs and neutralizing antibodies (NAbs) of TAB and ZAB.

Interventions

DRUGTybost 150 mg film-coated tablets
DRUGTivicay 50 mg film-coated tablets
DRUGINTELENCE 200 mg tablets
DRUGSunlenca 464 mg solution for injection
DRUGEmtriva 200 mg hard capsules
DRUGISENTRESS 400 mg film-coated tablets
DRUGEFAVIRENZ VIATRIS 600 mg
DRUGcomprimé pelliculé
DRUGREYATAZ 200 mg hard capsules
DRUGREKAMBYS 600 mg prolonged-release suspension for injection
DRUGZiagen 300 mg film-coated tablets
DRUGPifeltro 100 mg film-coated tablets
DRUGSunlenca 300 mg film-coated tablets
DRUGNorvir 100 mg powder for oral suspension
DRUGEpivir 150 mg film-coated tablets
DRUGGenvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets
DRUGGS-5423
DRUGREZOLSTA 800 mg/150 mg film-coated tablets
DRUGAptivus 250 mg soft capsules
DRUGGS-2872
DRUGViread 123 mg film-coated tablets

Sponsors

Gilead Sciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.—

Secondary

MeasureTime frame
Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 92 as defined by the US FDA snapshot algorithm., Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 52 and 92 as determined by the US FDA snapshot algorithm., Changes from baseline in CD4+ T-cell counts at Weeks 52 and 92., Proportion of participants experiencing TEAEs., Proportion of participants prematurely discontinuing their study treatment due to an AE., Trough concentrations at Weeks 26, 52, and 104 for LEN, TAB, and ZAB., Incidence of ADAs and neutralizing antibodies (NAbs) of TAB and ZAB.—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 22, 2026