PURPOSE S1826 was an international phase III randomized trial that demonstrated improved progression-free survival (PFS) of nivolumab plus doxorubicin, vinblastine, and dacarbazine (N + AVD) over brentuximab vedotin plus AVD (BV + AVD) in newly diagnosed advanced-stage classic Hodgkin lymphoma (cHL). Here we report results of enrolled participants with HIV. METHODS People with HIV (PWH) with a CD4 + T cell above ≥200 cells/µL and on effective antiretroviral therapy with an undetectable HIV viral load within 6 months before enrollment were eligible. Participants were randomly assigned in a 1:1 ratio to receive six 28-day cycles of either N + AVD or BV + AVD intravenously. The primary end point was PFS. RESULTS Sixteen eligible PWH were enrolled, 11 received N + AVD and five received BV + AVD. The median follow-up duration was 32.7 months in the N + AVD arm and 26.7 months in the BV + AVD arm. The 2-year PFS rate was 77.9% in the N + AVD arm and 75.0% in the BV + AVD arm. The 2-year OS was 85.7% in the N + AVD arm and 75.0% in the BV + AVD arm. Grade ≥3 adverse events were observed in 45% of participants in the N + AVD arm and 50% in the BV + AVD arm with more frequent febrile neutropenia and severe infections were observed in the BV + AVD arm. CONCLUSION N + AVD is safe and effective in newly diagnosed HIV-associated advanced-stage cHL.
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