Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Completed

Looking for future studies?

Key information

Conditions

Peripheral Neuropathy Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Ponce, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Exclusion criteria

Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
non-compliant during A0081066 trial
clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

Treatment and study plan

Pregabalin

Drug

75mg BID, titrated up to 300mg according to individual response and tolerability

Primary outcomes

Mean Visual Analogue Scale (VAS) Pain Scores

Time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint

Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.

Endpoint = last non-missing observation carried forward after Baseline visit.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Dec 13, 2005
Registry last updated: Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed