eligibility_summary
Step 1: Thai 18–50, RV254, acute HIV with early ART, ≥48 wks VL<50 on stable integrase ART, clinically stable, CD4≥450, willing to interrupt/restart ART. Exclude weight <50/>115 kg, HLA-B57:01/58:01, major illness, HBV/HCV, recent vaccines/biologics, severe allergy or ECG/QTc issues, or pregnancy. Step 2: after all products, wk47 VL<50 & CD4≥450, ATI ≤36 wks if no virologic failure, illness, recent NNRTI or LA ART, 3 missed visits, or pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1 (withdrawn) randomized open-label trial in ART-suppressed adults with acute-start HIV. Interventions: VRC07-523LS (human IgG1 bNAb to Env CD4-binding site, neutralization + Fc effector), PGDM1400LS (human IgG1 bNAb to Env V2-apex), N-803/ALT-803 (IL-15 superagonist cytokine complex, expands/activates NK and CD8 T cells), Ad26.Mos4.HIV (Ad26 viral-vector expressing mosaic Env/Gag-Pol, prime), MVA-BN-HIV (MVA vector mosaic booster), A244d11 gp120 (Env protein subunit), ALFQ (liposomal adjuvant with MPLA [TLR4 agonist] + QS-21). Targets/pathways: HIV-1 Env (CD4bs, V2-apex) and mosaic Env/Gag-Pol antigens, IL-15Rβγ signaling on NK/CD8 T cells, innate activation via TLR4 and APCs, induction of Env/Gag-Pol–specific B cells, CD4+ and CD8+ T cells, potential ADCC. Goal: boost immune control to delay viral rebound during ATI.