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Pregabalin Trial In HIV Neuropathic Pain

Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection; Neuropathic Pain

Intervention: pregabalin (Lyrica) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Spontaneous Adverse Event Monitoring.

Secondary outcome:

Work Productivity and Activity Impairment Questionnaire (WPAI:SHP)

Short Form 36 Health Survey (SF-36).

Pain VAS for the prior week.

Patient Global Impression of Change (PGIC).

Sheehan-Suicidality Tracking Scale (S-STS).

Patient Health Questionnaire-8 (PHQ-8).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who participated in the preceding A0081244 double-blind trial and completed

at least through Visit 9 of that trial.

Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.

Subjects who had acceptable tolerability of study drug in A0081244.

Exclusion Criteria:

- Clinically significant or unstable conditions that, in the opinion of the

investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.

- Other severe acute or chronic medical or psychiatric condition or laboratory

abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

- Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection

(OI) that requires hospitalization.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Instituto Dominicano de Estudios Virológicos - IDEV, Santo Domingo, Dominican Republic; Not yet recruiting
Ellen Koenig, MD, Phone: 1 809 2240019

Hospital Nacional Dos de Mayo, Lima L 01, Peru; Not yet recruiting
Eduardo R Ticona, MD, Phone: 511 993560268

Ponce School of Medicine-Practice Group, Ponce 00732-7004, Puerto Rico; Not yet recruiting
Elizabeth A Barranco Santana, MD, Phone: 787-840-2505

Ponce School of Medicine, Ponce 00716, Puerto Rico; Not yet recruiting
Elizabeth A Barranco Santana, MD, Phone: 787-840-2505

Puerto Rico Clinical and Translational Research Consortium, Rio Piedras 00935, Puerto Rico; Recruiting
Carlos A Luciano, MD, Phone: 787-759-0306, Ext: 228

Innovir Institute, Gauteng 2047, South Africa; Not yet recruiting
Steven D Miller, MBBCH, Phone: +2711-626-9900

Be Part Yoluntu Centre, Paarl 7626, South Africa; Recruiting
Elizabeth Hellstrom, Phone: +27 21 868 3990

Paarl Research Center, Paarl 7646, South Africa; Recruiting
Elizabeth Hellstrom, Phone: +27 21 868 3990

Neurology unit, Department of Medicine,, Bangkok 10400, Thailand; Recruiting
Pasiri Sithinamsuwan, Phone: +66 2 354 7600 ext. 93027

South East Asia Research Collaboration with Hawaii, Bangkok 10330, Thailand; Recruiting
Jintanat Ananworanich, Ph.D., Phone: +662 254 2566

Surakshaka Multispeciality Hospital, Hyderabad, Andhra Pradesh 500 072, India; Recruiting
Lily Rodrigues, Phone: +91-9885250500

Mahavir Hospital and Research Centre, Hyderabad, Andhra Pradesh 500 004, India; Not yet recruiting
Srinivas Kulkarni, Phone: +91-40-2379392

Arizona Research Center, Phoenix, Arizona 85023, United States; Active, not recruiting

Southwest Center for HIV/AIDS, Phoenix, Arizona 85006, United States; Not yet recruiting
Lawrence F Waldman, MD, Phone: 602-327-4642

Southwest Center for HIV/AIDS, Phoenix, Arizona 85006, United States; Active, not recruiting

Providence Clinical Research, Burbank, California 91505, United States; Recruiting
Teresa S Sligh, MD, Phone: 818-568-5050

AIDS Research Allicance, Los Angeles, California 90015, United States; Not yet recruiting
Stephen J Brown, MD, Email: s.brown@aidsresearch.org

Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group, Palm Springs, California 92262, United States; Recruiting
Seymour M Young, MD, Phone: 760-320-9505

University of California San Diego, San Diego, California 92103, United States; Not yet recruiting
Ronald J Ellis, MD, Phone: 619-543-5079

Stanford University Medical Center, Stanford, California 94305, United States; Recruiting
Yuen T So, MD, PhD, Phone: 650-723-5184

Asistencia Cientifica de Alta Complejidad, Bogota, Cundinamarca 0000, Colombia; Recruiting
Otto A Sussmann, MD, Phone: 573153206285

Riesgo de Fractura S.A., Bogota D.C., Cundinamarca, Colombia; Recruiting
Henry Mendoza Ramírez, MD, Phone: 57 1 6446804

MediSynergy, Port Elizabeth, Eastern Cape 6065, South Africa; Recruiting
Michelle Moorhouse, Phone: +27-76-071-9041

Neuroscience Consultants, Limited Liability Corporation, Aventura, Florida 33180, United States; Recruiting
Jeffrey B Gelblum, MD, Phone: 305-931-8080

South Florida Medical Research, Aventura, Florida 33180, United States; Recruiting
Jeffrey B Gelblum, MD, Phone: 305-931-8080

Toga Laboratory, Johannesburg, Gauteng 1610, South Africa; Recruiting
Valerie Keyser, Phone: +27 82 898 0405

Drs Essack and Mitha, Johannesburg, Gauteng 2113, South Africa; Recruiting
Essack Mitha, Phone: +27 82 322 3402

Pretoria West Hospital, Pretoria West, Gauteng 0117, South Africa; Recruiting
Zinhle N Makatini, Phone: +2712 380 1200

Infectious Disease Clinic, Ahmedabad, Gujarat 380 009, India; Recruiting
Atul Patel, Phone: 09426182696

Jaslok Hospital & Research Centre, Mumbai, Maharashtra 400 026, India; Not yet recruiting
Janak K Maniar, MD, DNB, Phone: 91-22-23680288

Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra 411 004, India; Recruiting
Rahul Kulkarni, Phone: +91-20-66023000 (Extn 1059)

Mount Sinai School of Medicine, New York, New York 10029, United States; Not yet recruiting
Kathryn Elliott, MD, Email: kathryn.elliott@mssm.edu

University of Cape Town, Cape Town, Western Cape 7925, South Africa; Recruiting
Jeannine M Heckmann, Phone: +2784 787 2200

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2010
Last updated: November 17, 2011

Page last updated: December 08, 2011

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