eligibility_summary
Adults 18–70, 50–115 kg, HIV‑1+, provide consent, not pregnant/breastfeeding, agree to contraception and barrier protection. Step 1: on suppressive ART ≥48 wks (VL<50), CD4>450 and ≥15%, nadir≥200, sensitive to 3BNC117‑LS & 10‑1074‑LS, acceptable labs, leukapheresis done. Exclude: recent AIDS, major comorbidity/malignancy/PML, recent LA ARVs, multiclass resistance, immunosuppression, acute‑ART start, prior HIV mAbs/vaccines, recent trials, HBV/HCV, ASCVD/high risk, cirrhosis, untreated STI. Step 2: willing for ATI. Step 3: restart per protocol or after 72 wks/A5385.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: 3BNC117-LS and 10-1074-LS—human IgG1 broadly neutralizing monoclonal antibodies (bNAbs) against HIV-1 Env. 3BNC117-LS targets the gp120 CD4-binding site, 10-1074-LS targets the gp120 V3-glycan supersite. “LS” Fc mutations increase FcRn binding and extend half-life, antibodies are given IV during analytical treatment interruption (ATI). Mechanisms: neutralize diverse HIV-1 strains, block gp120 engagement with CD4/co-receptors to prevent entry, and via Fc effector functions (ADCC/ADCP) may promote clearance of Env-expressing infected cells and potentially impact the latent reservoir. Targets: HIV-1 Env on virions and infected CD4+ T cells, pathways include virus entry (gp120–CD4/CCR5/CXCR4) and Fcγ receptor–mediated cytotoxic/phagocytic clearance. Trial status: withdrawn.