Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults

Phase 2 Completed 60 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).

Timeline

Start: 2016-05-16
Primary completion: 2018-02-18
Completion: 2018-04-04

Outcome

Missed primary endpoint

paper Primary safety events occurred in 2.5% (1 participant) for ruxolitinib and 0% for controls (P = .67). PMID 33693561 ↗

paper By week 5, differences in IL-6 (mean fold change [FC], 0.93 vs 1.10; P = .18) PMID 33693561 ↗

Publications

Marconi VC, Moser C, Gavegnano C, Deeks SG, Lederman MM, Overton ET, Tsibris A, Hunt PW, Kantor A, Sekaly RP, Tressler R, Flexner C, Hurwitz SJ, Moisi D, Clagett B, Hardin WR, Del Rio C, Schinazi RF, Lennox JJ. Randomized Trial of Ruxolitinib in Antiretroviral-Treated Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2022 Jan 7;74(1):95-104. doi: 10.1093/cid/ciab212.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	10 mg	Oral