eligibility_summary
Eligible: adults 18–70 with confirmed, stable HIV-1, on ART ≥96 weeks with HIV RNA <50 (1 blip <200 allowed), CD4 >300, consent/comply. If pregnancy risk: neg test + contraception, if can impregnate: condoms. Exclude: AIDS in last 3y, recent immunosuppressants/chemo, significant comorbidity, HBV or HCV RNA+, pregnancy/lactation, ART started in acute infection, key lab abnormalities, HIV mAb/vaccine history, recent trials/vaccines, poor leukapheresis access, substance misuse, IP hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1 randomized, placebo-controlled study in ART-suppressed adults testing 3BNC117-LS and 10-1074-LS—long-acting broadly neutralizing anti–HIV-1 monoclonal antibodies (human IgG1, Fc LS mutations for extended half-life). 3BNC117-LS targets the gp120 CD4-binding site, 10-1074-LS targets the gp120 V3 glycan (N332) supersite. Mechanisms: neutralize virus and block entry, engage Fcγ receptor–mediated effector functions (ADCC, phagocytosis) to eliminate Env-expressing infected cells, with the goal of shrinking the intact proviral reservoir. Targets: HIV-1 Env on virions and infected CD4+ T cells, the CD4+ T-cell latent reservoir, NK/myeloid Fc pathways, HIV-specific T-cell responses.