Pregabalin Trial In HIV Neuropathic Pain

Stopped early · Phase 3

Conditions studied: HIV-1 Infection, Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT01145417

Run by

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

People needed

217

Starts

2010-07-01

Expected to finish

2012-05-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southwest Center for HIV/AIDS — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Providence Clinical Research — Burbank, California, United States
• Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group — Palm Springs, California, United States
• University of California San Diego — San Diego, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Neuroscience Consultants, LLC — Aventura, Florida, United States
• South Florida Medical Research — Aventura, Florida, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Riesgo de Fractura S.A. — Bogota D.C., Cundinamarca, Colombia
• Asistencia Cientifica de Alta Complejidad — Bogota, Cundinamarca, Colombia
• Surakshaka Multispeciality Hospital — Hyderabad, Andhra Pradesh, India
• Infectious Disease Clinic — Ahemdabad, Gujarat, India
• Deenanath Mangeshkar Hospital and Research Centre — Pune, Maharashtra, India
• Hospital Nacional Dos de Mayo — Lima, Peru
• RCMI-Clinical Research Center — Rio Piedras, Puerto Rico
• MediSynergy — Port Elizabeth, Eastern Cape, South Africa
• Worthwhile Clinical Trials (WWCT), Lake View Hospital — Benoni, Gauteng, South Africa
• Toga Laboratory — Johannesburg, Gauteng, South Africa
• Drs Essack and Mitha — Johannesburg, Gauteng, South Africa
• Pretoria West Hospital — Pretoria West, Gauteng, South Africa
• Dr J. Reddy's Surgery — KwaDukuza, KwaZulu-Natal, South Africa
• University of Cape Town — Cape Town, Western Cape, South Africa
• Synapta Clinical Research Centre — Durban, South Africa

Full record on ClinicalTrials.gov

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