eligibility_summary
Inclusion: Stable oral ART with <=2 drug classes (boosters allowed) for >=1 yr, regimen change >=28 d prior for non-VF OK, no significant resistance except M184V or <=2 TAMs, HIV-1 RNA <50 c/mL at screening and for >=12 mo (blips OK), proviral sensitivity to teropavimab & zinlirvimab, CD4 >=200/uL. Exclusion: ongoing immunosuppression, current HCV or HBV (cleared HCV OK), prior opportunistic infection/Stage 3 HIV. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 2 randomized, open-label study in virologically suppressed adults with HIV-1 tests switching to a long-acting regimen of lenacapavir plus two broadly neutralizing antibodies (bNAbs), teropavimab and zinlirvimab, dosed every 6 months, versus continuing oral ART. Lenacapavir (GS-6207, Sunlenca) is a small-molecule HIV-1 capsid inhibitor that binds p24, disrupting capsid assembly/disassembly, nuclear import, and virion maturation across early and late replication steps. Teropavimab (GS-5423) and zinlirvimab (GS-2872) are IV bNAb monoclonal antibodies against conserved HIV-1 envelope epitopes, blocking viral entry and enabling Fc-mediated clearance of infected cells. Targets/pathways: HIV-1 capsid functions, Env-mediated attachment/fusion on CD4+ T cells and reservoirs. Primary outcome: HIV-1 RNA ≥50 copies/mL at Week 26.