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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)

This study is currently Recruiting

October 2011 By Pfizer

First Recieved on January 13, 2010

Last Updated on October 26, 2011

Sponsor: Pfizer
Collaborators:
Information provided by: Pfizer
Identifier: NCT01049217

Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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) with subjective sensory symptom of pain - Pain starts in the feet Exclusion Criteria: - 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

Investigators

  • Investigator: Pfizer CT.gov Call Center - Study Director - Pfizer

Locations

  • SW Center for HIV/AIDS

    Phoenix, Arizona 85006 United States

  • Arizona Research Center

    Phoenix, Arizona 85023 United States

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona 85006 United States

  • Providence Clinical Research

    Burbank, California 91505 United States

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

    Los Angeles, California 90095 United States

  • Anthony Mills, MD, Inc.

    Los Angeles, California 90069 United States

  • AIDS Research Alliance of America

    Los Angeles, California 90015 United States

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

    Palm Springs, California 92262 United States

  • University of California San Diego

    San Diego, California 92103 United States

  • Stanford University Medical Center

    Stanford, California 94305 United States

  • Neuroscience Consultants, LLC.

    Aventura, Florida 33180 United States

  • South Florida Medical Research

    Aventura, Florida 33180 United States

  • The Kinder Medical Group

    Miami, Florida 33133 United States

  • Wohlfeiler, Piperato & Associates, LLC

    Miami Beach, Florida 33139 United States

  • Meridien Research

    Tampa, Florida 33606 United States

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308 United States

  • Neurology Specialists of Decatur Research Center

    Decatur, Georgia 30033 United States

  • Rehabilitation Institute of Chicago

    Chicago, Illinois 60611 United States

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657 United States

  • Chicago Anesthesia Pain Specialists

    Chicago, Illinois 60657 United States

  • Johns Hopkins University

    Baltimore, Maryland 21287 United States

  • Mount Sinai School of Medicine

    New York, New York 10029 United States

  • University of Toledo

    Toledo, Ohio 43614 United States

  • University of Texas Physicians

    Bellaire, Texas 77401 United States

  • Amelia Court HIV Research Clinic

    Dallas, Texas 75235 United States

  • The University of Texas Medical School at Houston

    Houston, Texas 77030 United States

  • Centro Instituto de Investigaciones Fundaci?n Universitaria Sanitas

    Bogota, Cundinamarca Colombia

  • Asistencia Cientifica de Alta Complejidad

    Bogota, Cundinamarca 0000 Colombia

  • Riesgo de Fractura S.A

    Bogot?, Cundinamarca 0000 Colombia

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

    Bucaramanga, Santander 0000 Colombia

  • Instituto Dominicano de Estudios Virol?gicos - IDEV

    Santo Domingo, Dominican Republic

  • Surakshaka Multispeciality Hospital

    Hyderabad, Andhra Pradesh 500 072 India

  • Mahavir Hospital and Research Centre

    Hyderabad, Andhra Pradesh 500 004 India

  • Infectious Disease Clinic

    Ahmedabad, Gujarat 380 009 India

  • Jaslok Hospital & Research Centre

    Mumbai, Maharashtra 400026 India

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra 411 004 India

  • YR Gaitonde Centre for AIDS Research and Education

    Chennai, Tamil Nadu 600 113 India

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226 014 India

  • Hospital Nacional Dos de Mayo

    Lima, L 01 Peru

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, L 13 Peru

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

    Bydgoszcz, 85-030 Poland

  • Oddzial Diagnostyki i Terapii AIDS

    Chorzow, 41-500 Poland

  • Ararat Research Center

    Ponce, 00717-1563 Puerto Rico

  • Ponce School of Medicine-CAIMED Center

    Ponce, 00716 Puerto Rico

  • Ponce School of Medicine - Practice Group

    Ponce, 00732-7004 Puerto Rico

  • Puerto Rico Clinical and Translational Research Consortium

    Rio Piedras, 00935 Puerto Rico

  • Border Diabetic Centre

    East London, Eastern Cape 5200 South Africa

  • MediSynergy

    Port Elizabeth, Eastern Cape 6065 South Africa

  • Worthwhile Clinical Trials

    Benoni, Gauteng 1500 South Africa

  • Toga Laboratory

    Johannesburg, Gauteng 1610 South Africa

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

    Johannesburg, Gauteng 2193 South Africa

  • Drs Essack and Mitha

    Johannesburg, Gauteng 2113 South Africa

  • Synexus SA Stanza Bopape Clinical Research Centre

    Pretoria, Gauteng 0122 South Africa

  • Pretoria West Hospital

    Pretoria West, Gauteng 0117 South Africa

  • Chris Hani Baragwanath Hospital, The Palliative Care Centre

    Soweto, Gauteng 1808 South Africa

  • Dr J. Reddy's Surgery

    Stanger, KwaZulu Natal 4450 South Africa

  • University of Cape Town

    Cape Town, Western Cape 7925 South Africa

  • Synapta Clinical Research Centre

    Durban, 4001 South Africa

  • Innovir Institute

    Gauteng, 2047 South Africa

  • Mzansi Ethical Research Centre

    Middelburg, 1050 South Africa

  • Be Part Yoluntu Centre

    Paarl, 7626 South Africa

  • Paarl Research Center

    Paarl, 7646 South Africa

  • Neurology unit, Department of Medicine,

    Bangkok, 10400 Thailand

  • South East Asia Research Collaboration with Hawaii

    Bangkok, 10330 Thailand

Conditions related to this trial:

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