Safety, Immunovirologic, and Central Nervous System Effects of PD-1 Inhibition in People With HIV Without Malignancy
Checkpoint inhibitors are being explored for chronic central nervous system (CNS) infections such as HIV, but safety data in the absence of malignancy are limited. In this phase I, non-randomized study, six virally suppressed individuals with HIV received a single dose of pembrolizumab to assess safety and effects on immune, virologic, and CNS parameters. Over 12 months, 29 adverse events occurred, all grade 1-2, with no serious events. HIV immune responses and viral loads were unchanged, although transient CSF viral increases occurred in two participants. A single dose pembrolizumab appears safe, supporting evaluation of repeated dosing.
Authors
- Avindra Nath (ORCID: https://orcid.org/0000-0003-0927-5855)
- Jessica Gill (ORCID: https://orcid.org/0000-0002-3689-7441)
- Bryan Smith (ORCID: https://orcid.org/0000-0001-9850-5944)
- Swati Shah (ORCID: https://orcid.org/0000-0002-7333-9086)
- Lauren Reoma (ORCID: https://orcid.org/0000-0001-6305-7723)
- Eli Boritz (ORCID: https://orcid.org/0000-0003-4633-4594)
- Manahel Zahid
- Mark Connors (ORCID: https://orcid.org/0000-0002-2108-8705)
- Amanda Wiebold
- Stephen A. Migueles (ORCID: https://orcid.org/0000-0002-6062-8022)
- Peter D. Burbelo (ORCID: https://orcid.org/0000-0003-1717-048X)
- Ken Cheung
- Dima A. Hammoud (ORCID: https://orcid.org/0000-0001-7406-7871)
- Frank M. Maldarelli (ORCID: https://orcid.org/0000-0002-3062-5250)
- Tory P. Johnson (ORCID: https://orcid.org/0000-0001-7468-3586)
- J. Shin
- Anna Lyndaker (ORCID: https://orcid.org/0009-0004-8699-4129)
- Liliana Pérez
- Govind Nair
- Chen Lai
- H Clifford Lane
Institutions
- Henry M. Jackson Foundation (US)
- Uniformed Services University of the Health Sciences (US)
- Cancer Institute (WIA) (IN)
- National Institute of Dental and Craniofacial Research (US)
- National Institute of Neurological Disorders and Stroke (US)
- Institut de Recherche Vaccinale (FR)
- National Institute of Allergy and Infectious Diseases (US)
- Office of the Director (US)
- Center for Neuroscience and Regenerative Medicine (US)
- Center for Cancer Research (US)
- Imaging Center (US)
- Columbia University (US)
Publication Details
- Journal
- The Journal of Infectious Diseases
- Published
- 2026-03-04
- DOI
- https://doi.org/10.1093/infdis/jiag127
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00