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

Last updated: January 26, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Terminated

Phase

3

Condition

Neuropathy

Neurologic Disorders

Pain

Treatment

N/A

Clinical Study ID

NCT01049217
A0081244
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or iftreated 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), DiabeticPeripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy,radicular pain, other infection related neuropathies (eg, leprosy); neuropathy relatedto: metabolic abnormalities; nutritional factors; vascular insults; inflammation;autoimmune disease; and malignancy

Study Design

Total Participants: 377
Study Start date:
April 01, 2010
Estimated Completion Date:
May 31, 2012

Study Description

Based on 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 patient health.

Connect with a study center

  • Asistencia Cientifica de Alta Complejidad

    Bogota, Cundinamarca 0000
    Colombia

    Site Not Available

  • Centro Instituto de Investigaciones Fundación Universitaria Sanitas

    Bogota, Cundinamarca
    Colombia

    Site Not Available

  • Riesgo de Fractura S.A

    Bogotá, Cundinamarca 0000
    Colombia

    Site Not Available

  • Riesgo de Fractura S.A

    Bogotá, Cundinamarca 0000
    Colombia

    Site Not Available

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

    Bucaramanga, Santander 0000
    Colombia

    Site Not Available

  • Instituto Dominicano de Estudios Virológicos - IDEV

    Santo Domingo,
    Dominican Republic

    Site Not Available

  • Mahavir Hospital and Research Centre

    Hyderabad, Andhra Pradesh 500 004
    India

    Site Not Available

  • Surakshaka Multispeciality Hospital

    Hyderabad, Andhra Pradesh 500 072
    India

    Site Not Available

  • Infectious Disease Clinic

    Ahmedabad, Gujarat 380 009
    India

    Site Not Available

  • Jaslok Hospital & Research Centre

    Mumbai, Maharashtra 400026
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra 411 004
    India

    Site Not Available

  • YR Gaitonde Centre for AIDS Research and Education

    Chennai, Tamil Nadu 600 113
    India

    Site Not Available

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226 014
    India

    Site Not Available

  • Hospital Nacional Dos de Mayo

    Lima, L 01
    Peru

    Site Not Available

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, L 13
    Peru

    Site Not Available

  • Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy

    Bydgoszcz, 85-030
    Poland

    Site Not Available

  • Oddzial Diagnostyki i Terapii AIDS

    Chorzow, 41-500
    Poland

    Site Not Available

  • Ponce School of Medicine - Practice Group

    Ponce, 00732-7004
    Puerto Rico

    Site Not Available

  • Ponce School of Medicine-CAIMED Center

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Puerto Rico Clinical and Translational Research Consortium

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Border Diabetic Centre

    East London, Eastern Cape 5200
    South Africa

    Site Not Available

  • MediSynergy

    Port Elizabeth, Eastern Cape 6065
    South Africa

    Site Not Available

  • Worthwhile Clinical Trials

    Benoni, Gauteng 1500
    South Africa

    Site Not Available

  • Drs Essack and Mitha

    Johannesburg, Gauteng 2113
    South Africa

    Site Not Available

  • Toga Laboratory

    Johannesburg, Gauteng 1610
    South Africa

    Site Not Available

  • University of Witwatersrand-Clinical HIV Research Unit (CHRU)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Synexus SA Stanza Bopape Clinical Research Centre

    Pretoria, Gauteng 0122
    South Africa

    Site Not Available

  • Pretoria West Hospital

    Pretoria West, Gauteng 0117
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Hospital, The Palliative Care Centre

    Soweto, Gauteng 1808
    South Africa

    Site Not Available

  • Dr J. Reddy's Surgery

    Stanger, KwaZulu Natal 4450
    South Africa

    Site Not Available

  • University of Cape Town

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Synapta Clinical Research Centre

    Durban, 4001
    South Africa

    Site Not Available

  • Innovir Institute

    Gauteng, 2047
    South Africa

    Site Not Available

  • Mzansi Ethical Research Centre

    Middelburg, 1050
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre

    Paarl, 7626
    South Africa

    Site Not Available

  • Paarl Research Center

    Paarl, 7646
    South Africa

    Site Not Available

  • Clinical Research Unit, University of Pretoria

    Pretoria, 0002
    South Africa

    Site Not Available

  • Department of Neurology

    Tygerberg, 7505
    South Africa

    Site Not Available

  • Neurology unit, Department of Medicine,

    Bangkok, 10400
    Thailand

    Site Not Available

  • South East Asia Research Collaboration with Hawaii

    Bangkok, 10330
    Thailand

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • SW Center for HIV/AIDS

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Providence Clinical Research

    Burbank, California 91505
    United States

    Site Not Available

  • AIDS Research Alliance of America

    Los Angeles, California 90015
    United States

    Site Not Available

  • Anthony Mills, MD, Inc.

    Los Angeles, California 90069
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA c/o NNAB

    Los Angeles, California 90095
    United States

    Site Not Available

  • CTSC Clinical Research Center (CCRC)

    Mather, California 95655
    United States

    Site Not Available

  • Providence Clinical Research

    North Hollywood, California 91606
    United States

    Site Not Available

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

    Palm Springs, California 92262
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Neuroscience Consultants, LLC.

    Aventura, Florida 33180
    United States

    Site Not Available

  • South Florida Medical Research

    Aventura, Florida 33180
    United States

    Site Not Available

  • The Kinder Medical Group

    Miami, Florida 33133
    United States

    Site Not Available

  • Wohlfeiler, Piperato & Associates, LLC

    Miami Beach, Florida 33139
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33606
    United States

    Site Not Available

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Midtown Neurology, PC

    Atlanta, Georgia 30312
    United States

    Site Not Available

  • Neurology Specialists of Decatur Research Center

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Rehabilitation Institute of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • SUNY-Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • University of Toledo

    Toledo, Ohio 43614
    United States

    Site Not Available

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • University of Texas Physicians

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Amelia Court HIV Research Clinic

    Dallas, Texas 75235
    United States

    Site Not Available

  • The University of Texas Medical School at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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