Pregabalin Trial In HIV Neuropathic Pain

Phase 3 Terminated 217 enrolled Viatris Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.

Timeline

Start: 2010-07
Primary completion: 2012-05
Completion: 2012-05

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

paper was -2.04 for pregabalin versus -2.11 for placebo (P=.709). PMID 24907403 ↗

paper Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. PMID 24907403 ↗

Publications

Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	Pregabalin	Small molecule	600 mg	—