Pregabalin Trial In HIV Neuropathic Pain

NCT ID: NCT01145417

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-05-31

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 pregabalin.

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 was unrelated to any safety findings that could impact patient health.

Conditions

HIV-1 Infection; Neuropathic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pregabalin (Lyrica)

Group Type: EXPERIMENTAL

pregabalin (Lyrica)

Intervention Type: DRUG

150 mg-600 mg/day (twice daily)

Interventions

pregabalin (Lyrica)

150 mg-600 mg/day (twice daily)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Paarl Research Center

Paarl, , South Africa

Be Part Yoluntu Centre

Paarl, , South Africa

South East Asia Research Collaboration with Hawaii

Bangkok, , Thailand

Neurology unit, Department of Medicine,

Bangkok, , Thailand

Countries

United States; Colombia; India; Peru; Puerto Rico; South Africa; Thailand

References

Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24907403 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081251&StudyName=Pregabalin%20Trial%20In%20HIV%20Neuropathic%20Pain

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

Other Identifiers

A0081251

Identifier Type: -

Identifier Source: org_study_id