NCT01145417

Pregabalin Trial In HIV Neuropathic Pain

An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Conditions

• HIV-1 Infection
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	pregabalin (Lyrica)	150 mg-600 mg/day (twice daily)

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-06-16
• Last updated: 2021-01-28
• Results posted: 2013-06-27

Locations

29 sites across 7 countries: United States, Colombia, India, Peru, Puerto Rico, South Africa, Thailand