eligibility_summary
Include: 18–70, confirmed primary HIV‑1, insured, consented, COVID‑vaccinated, contraception and negative β‑hCG if applicable, agree to avoid pregnancy and trial demands (travel, ART pause). Exclude: other interventional trials, pregnancy/breastfeeding, condom/partner PrEP infeasible, guardianship, HBV/HCV/SARS‑CoV‑2/active TB, ischemic heart disease, cancer (except SCC), ocular inflammation, ART pause or mAb contraindications, severe allergy, recent immunosuppressants (≤6m), PT<50%, CrCl<60, LFTs/bili≥10×ULN, HIV‑2, planned absence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: ART plus dual long-acting broadly neutralizing antibodies (bNAbs) 3BNC117-LS and 10-1074-LS vs ART plus placebo at primary HIV-1 infection, followed by analytical treatment interruption. Drug types/mechanisms: 3BNC117-LS (recombinant human monoclonal bNAb) binds the HIV-1 Env gp120 CD4-binding site, 10-1074-LS (bNAb) binds the gp120 V3-glycan (N332) supersite. Both neutralize diverse virions, block Env–CD4 interaction/entry, and via Fc functions (ADCC/ADCP) can help clear infected cells, LS Fc changes extend half-life via FcRn. Background ART uses an integrase inhibitor + two NRTIs, blocking integration and reverse transcription. Targets: HIV-1 Env on virions/infected cells, infection of CD4+ T cells, Fcγ-receptor effector pathways (NK cells/macrophages), HIV replication steps (RT, integration).