eligibility_summary
Eligibility: Step1—EIT/Tatelo or Moso cohort, age 24 wks–12 y, on ART ≥24 wks, afebrile, normal labs, HIV RNA suppressed (1a <40, 1b <200 with recent <40), not pregnant, consent. Step2—≥Week24 of Step1, sustained <40, bNAb susceptible or EIA/DNA negative. Step3—long-term suppression, reservoir criteria (non-encoding/no intact virus), CMC OK, contraception/breastfeeding rules. Step4—any completer. Exclude: active TB/malignancy, HBsAg+, recent immunoglobulin or chronic steroids, unsafe conditions, Step1/2 weight <5 or >115 kg, recent NNRTI (Step3 direct).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06508749 (Tatelo Plus) tests a triple broadly neutralizing antibody (bNAb) regimen in early-treated children with HIV. Drugs: PGDM1400LS, VRC07‑523LS, and PGT121.414.LS—human IgG1 monoclonal antibodies engineered with LS mutations for extended half‑life (enhanced FcRn binding). Mechanisms: bind distinct HIV‑1 Env gp120 sites to block viral entry and neutralize virions—PGDM1400LS targets the V2 apex, VRC07‑523LS targets the CD4 binding site, and PGT121.414.LS targets the V3 glycan (N332) patch. Their Fc domains can engage Fcγ receptors to mediate ADCC/ADCP, aiding clearance of Env‑expressing infected cells and potentially reducing the viral reservoir. Interventions include rotating IV bNAb dosing on/off ART and Analytic Treatment Interruption (ATI: stopping ART ± bNAbs) to test maintenance of suppression. Targets: HIV Env, circulating virions, and infected CD4+ T cells, pathways: viral entry blockade and Fc‑mediated effector functions.