Status:
TERMINATED
Pregabalin Trial In HIV Neuropathic Pain
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
HIV-1 Infection
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pregabali...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01145417
Start Date
July 1 2010
End Date
May 1 2012
Last Update
January 28 2021
Active Locations (29)
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1
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States, 85006
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Providence Clinical Research
Burbank, California, United States, 91505
4
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262