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.
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.
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
