Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

NCT01049217 | Terminated Phase 3 Results DMC

• 1 other identifier: A0081244
• Study Type: interventional
• Target: 377
• Locations: 9 countries
• Sites: 63

Brief Summary

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Conditions

Neuropathy

Keywords

neuropathy; pain; HIV-1; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)

  Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).

  Baseline, Endpoint (up to Week 16)

Secondary Outcomes (21)

• Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)

  Week 16

• Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)

  Week 16

• Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)

• Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)

• Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)

  Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)

Other Outcomes (11)

• Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose

• Number of Participants With Abnormal Laboratory Test Findings

  Screening up to Week 17

• Number of Participants With Positive Serum and Urine Pregnancy

  Screening for serum pregnancy test, Week 1 for urine pregnancy test

Study Arms (2)

Active drug

EXPERIMENTAL

Drug: pregabalin

Control

PLACEBO COMPARATOR

Drug: placebo

Interventions

pregabalin DRUG

Pregabalin 75 mg-300mg twice daily during the course of the study.

Active drug

placebo DRUG

Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, ages of 18 or greater
• Documented evidence of HIV-1 infection
• Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
• Pain starts in the feet

You may not qualify if:

• Subject has untreated vitamin B12 deficiency (serum B12 level \<200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
• Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C \>6.9
• Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy

Sponsors & Collaborators

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

Study Sites (63)

Southwest Center for HIV/AIDS

Phoenix, Arizona, 85006, United States

Location

SW Center for HIV/AIDS

Phoenix, Arizona, 85006, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

AIDS Research Alliance of America

Los Angeles, California, 90015, United States

Location

Anthony Mills, MD, Inc.

Los Angeles, California, 90069, United States

Location

David Geffen School of Medicine at UCLA c/o NNAB

Los Angeles, California, 90095, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Neuroscience Consultants, LLC.

Aventura, Florida, 33180, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

Wohlfeiler, Piperato & Associates, LLC

Miami Beach, Florida, 33139, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Midtown Neurology, PC

Atlanta, Georgia, 30312, United States

Location

Neurology Specialists of Decatur Research Center

Decatur, Georgia, 30033, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

University of Texas Physicians

Bellaire, Texas, 77401, United States

Location

Amelia Court HIV Research Clinic

Dallas, Texas, 75235, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Asistencia Cientifica de Alta Complejidad

Bogota, Cundinamarca, 0000, Colombia

Location

Centro Instituto de Investigaciones Fundación Universitaria Sanitas

Bogota, Cundinamarca, Colombia

Location

Riesgo de Fractura S.A

Bogotá, Cundinamarca, 0000, Colombia

Location

Instituto Colombiano para el Avance de la Medicina- Santander S.A.S. - ICAMEDIC Santander S.A.S

Bucaramanga, Santander Department, 0000, Colombia

Location

Instituto Dominicano de Estudios Virológicos - IDEV

Santo Domingo, Dominican Republic

Location

Mahavir Hospital and Research Centre

Hyderabad, Andhra Pradesh, 500 004, India

Location

Surakshaka Multispeciality Hospital

Hyderabad, Andhra Pradesh, 500 072, India

Location

Infectious Disease Clinic

Ahmedabad, Gujarat, 380 009, India

Location

Jaslok Hospital & Research Centre

Mumbai, Maharashtra, 400026, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411 004, India

Location

YR Gaitonde Centre for AIDS Research and Education

Chennai, Tamil Nadu, 600 113, India

Location

Hospital Nacional Dos de Mayo

Lima, L 01, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen

Lima, L 13, Peru

Location

Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy

Bydgoszcz, 85-030, Poland

Location

Oddzial Diagnostyki i Terapii AIDS

Chorzów, 41-500, Poland

Location

Ponce School of Medicine-CAIMED Center

Ponce, PR, 00716, Puerto Rico

Location

Ponce School of Medicine - Practice Group

Ponce, PR, 00732-7004, Puerto Rico

Location

Puerto Rico Clinical and Translational Research Consortium

Rio Piedras, PR, 00935, Puerto Rico

Location

Border Diabetic Centre

East London, Eastern Cape, 5200, South Africa

Location

MediSynergy

Port Elizabeth, Eastern Cape, 6065, South Africa

Location

Worthwhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

Toga Laboratory

Johannesburg, Gauteng, 1610, South Africa

Location

Drs Essack and Mitha

Johannesburg, Gauteng, 2113, South Africa

Location

University of Witwatersrand-Clinical HIV Research Unit (CHRU)

Johannesburg, Gauteng, 2193, South Africa

Location

Synexus SA Stanza Bopape Clinical Research Centre

Pretoria, Gauteng, 0122, South Africa

Location

Pretoria West Hospital

Pretoria West, Gauteng, 0117, South Africa

Location

Chris Hani Baragwanath Hospital, The Palliative Care Centre

Soweto, Gauteng, 1808, South Africa

Location

Dr J. Reddy's Surgery

KwaDukuza, KwaZulu-Natal, 4450, South Africa

Location

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

Synapta Clinical Research Centre

Durban, 4001, South Africa

Location

Innovir Institute

Gauteng, 2047, South Africa

Location

Mzansi Ethical Research Centre

Middelburg, 1050, South Africa

Location

Be Part Yoluntu Centre

Paarl, 7626, South Africa

Location

Paarl Research Center

Paarl, 7646, South Africa

Location

Clinical Research Unit, University of Pretoria

Pretoria, 0002, South Africa

Location

Department of Neurology

Tygerberg, 7505, South Africa

Location

South East Asia Research Collaboration with Hawaii

Bangkok, 10330, Thailand

Location

Neurology unit, Department of Medicine,

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 24907403 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain; HIV Infections

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Based on Data Monitoring Committee (DMC) interim efficacy analysis results indicating a low probability for success, the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact participant health.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: July 17, 2013

Record last verified: 2013-08

Locations

PL (2); US (25); IN (6); CO (4); DO (1); ZA (18); TH (2); PR (3); PE (2)