eligibility_summary
Key eligibility: Good health, on ART ≥12 months and stable ≥8 weeks, current regimen excludes NNRTIs and long-acting ART, HIV-2 Ab negative, CD4+ ≥500 at screening and none <500 in past 12 months, HIV-1 RNA undetectable at screening and for ≥12 months. Exclude: prior long-acting ARV exposure within 24 weeks/5 half-lives, CD4 nadir ≤200 during chronic infection, other conditions posing risk or confounding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06032546 (terminated): Phase 2 randomized, double‑blind, placebo‑controlled study in adults with well‑controlled HIV on ART undergoing analytical treatment interruption to test two immunotherapies. 1) Budigalimab (ABBV‑181): a monoclonal antibody immune‑checkpoint inhibitor (anti‑PD‑1, IgG1) given IV (Part 1) or SC (Part 2), mechanism: blocks PD‑1 to reverse T‑cell exhaustion and enhance HIV‑specific CD8+/CD4+ T‑cell function. 2) ABBV‑382: an investigational anti‑HIV monoclonal antibody, the record does not specify its exact target, but it is intended to directly target HIV (e.g., envelope) to help control viremia, potentially via neutralization and immune effector engagement. Targeted cells/pathways: PD‑1/PD‑L1 checkpoint on T cells (restoring antiviral immunity) and HIV particles/infected cells (via antibody binding). Arms include monotherapy and combination vs placebo during ATI.