A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

Summary

This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

Timeline

Start

2020-01-30

Primary completion

2023-02-27

Completion

2023-02-27

Publications

• Ramgopal MN, Lalezari JP, Pires Dos Santos AG, Krishnan P, Vaidya TR, Zhou F, Betman H, Dorr P, Mostafa NM, Alcaide ML, Felizarta F, Routy JP. Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study. Nat Med. 2025 Nov;31(11):3879-3888. doi: 10.1038/s41591-025-03993-0. Epub 2025 Oct 15.

Drugs

Indications