eligibility_summary
Inclusion: Documented HIV-1, on suppressive ART ≥96 weeks (VL<50, ≤2 blips), CD4>450, acceptable labs (eGFR≥60, normal LFTs, counts), agrees to ATI with monitoring, barrier protection, pregnancy testing and contraception/condoms, no other investigational drugs. Exclusion: AIDS hx/nadir CD4<200, malignancy or PML, recent NNRTI or LA-ARVs, multiclass resistance (except M184V), ART in acute infection, HBV/HCV/TB, ASCVD/cirrhosis, untreated STIs. Step2/3: continue ATI, restart per criteria.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: 3BNC117-LS-J (30 mg/kg IV) plus 10-1074-LS-J (10 mg/kg IV) versus placebo during an analytical treatment interruption. Type/mechanism: Both are long-acting, LS-engineered human IgG1 broadly neutralizing monoclonal antibodies (bNAbs) to HIV-1 Env gp120. 3BNC117 targets the CD4-binding site, 10-1074 targets the V3-glycan (N332) supersite. They neutralize free virions and block Env–CD4/coreceptor-mediated entry, and via Fc domains can recruit effector functions (ADCC/ADCP) against Env-expressing infected cells, LS mutations enhance FcRn binding to extend half-life. Targets: HIV-1 Env on virions and infected CD4+ T cells, viral entry pathway, FcγR-dependent pathways in NK cells/macrophages. Purpose: assess safety and antiviral/immunomodulatory activity and delay of rebound off ART.