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Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
This study is ongoing, but not recruiting participants.
First Received: December 3, 2002   Last Updated: July 31, 2008   History of Changes
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Neurologic AIDS Research Consortium (NARC)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050271
  Purpose

The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.


Condition Intervention
HIV Infections
Peripheral Nervous System Diseases
Drug: Acetyl-L-carnitine

MedlinePlus related topics: AIDS Neurologic Diseases Peripheral Nerve Disorders
Drug Information available for: Carnitine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 36
Detailed Description:

Distal symmetric peripheral neuropathy (DSPN) is the most frequent neurologic complication of HIV infection and its treatments. NRTIs, particularly dideoxy-NRTIs, represent a significant risk factor for developing neuropathy. To date, there are no effective treatments for DSPN. Studies of nonneuronal tissues indicate a beneficial effect of ALC in HIV-1 seropositive individuals, but the role of ALC levels in patients with DSPN is unclear. Despite conflicting data, carnitine and its derivatives are still commonly used.

Patients will have a screening visit and visits at entry and Weeks 6, 12, 18, and 24. Patients are required to fast (no food or drink except water) for 4-12 hours for the screening visit, entry visit, and at Weeks 12 and 24. Targeted physical examinations, blood chemistries, liver function tests, HIV-1 RNA, CD4/CD8 cell counts, hematology, and lactate assessments will be done. Patients will also have a small skin biopsy at entry and Week 24. Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily. They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study (24 weeks).

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection
  • Viral load <= 10,000 copies/ml within 60 days of entry
  • On stable antiretroviral medication for 8 weeks prior to entry and plan on staying on current regimen for the duration of the study
  • Currently taking at least one dideoxynucleoside analogue. Patients discontinuing their dideoxynucleoside analogues or changing their antiretroviral regimen after entry will remain on study drug and continue with the study requirements and evaluation visits.
  • No significant systemic antiretroviral toxicity
  • Evidence of predominantly sensory neuropathy, as determined from an examination by a neurologist
  • Ongoing neuropathy of any duration
  • Negative pregnancy test performed at screening and within 24 hours of study entry
  • Agree not to become pregnant or to impregnate; agree to use acceptable methods of contraception

Exclusion Criteria:

  • ALC or similar drug within 90 days of entry
  • Active AIDS-defining opportunistic infection (OI) or OI-defining condition within 30 days prior to entry
  • Any condition or history of any condition, other than that related to HIV infection or antiretroviral therapy, that would add confusion to the diagnosis of dideoxynucleoside analogue-associated DSPN
  • Pregnancy or breast-feeding
  • Active malignancy
  • Seizure disorder or history of seizure within 90 days of entry
  • Current or history of bipolar disorder
  • Certain drugs within 30 days of study entry
  • Addition of certain pain medication during the 60 days prior to study entry
  • Allergy/sensitivity to study drug or its formulations
  • Any condition that, in the opinion of the site investigator, would interfere with the study requirements
  • Myelopathy
  • Use of investigational agents that are not FDA-approved within 30 days of study entry, except when approved by the study chair. Investigational antiretroviral drugs available through expanded access or through AACTG trials will be allowed if they do not conflict with study criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050271

Locations
United States, California
Univ of Texas, Southwestern Med Ctr
Sacramento, California, United States, 95814
Stanford Univ
Stanford, California, United States, 94305
University of California, San Diego Antiviral Research
San Diego, California, United States, 92103
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Illinois
Cook County Hosp Core Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ
Chicago, Illinois, United States, 60611-3015
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8106
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Missouri
Washington University (St. Louis)
St. Louis, Missouri, United States, 63108-2138
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
The Cornell Clinical Trials Unit
New York, New York, United States, 10021
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, Texas
Univ of Texas, Galveston
Galveston, Texas, United States, 77555-0435
United States, Washington
Univ of Washington (Seattle)
Seattle, Washington, United States, 90033-1079
Puerto Rico
.University of Puerto Rico
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Neurologic AIDS Research Consortium (NARC)
Investigators
Study Chair: Victor Valcour, M.D. University of Hawaii
Study Chair: Russell Bartt, M.D. Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG A5157
Study First Received: December 3, 2002
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00050271     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acetylcarnitine
Dideoxynucleosides
Epidermis
Biopsy
Immunohistochemistry
Nerve Fibers
Treatment Experienced

Study placed in the following topic categories:
Antimetabolites
Nootropic Agents
Sexually Transmitted Diseases, Viral
Vitamin B Complex
Acquired Immunodeficiency Syndrome
Trace Elements
Dideoxynucleosides
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
Neuromuscular Diseases
HIV Infections
Vitamins
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Micronutrients
Retroviridae Infections
Carnitine
Acetylcarnitine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dideoxynucleosides
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Neuromuscular Diseases
Therapeutic Uses
Vitamins
Micronutrients
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Acetylcarnitine
Nootropic Agents
RNA Virus Infections
Vitamin B Complex
Immune System Diseases
Growth Substances
Nervous System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on May 07, 2009