Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Neurologic AIDS Research Consortium (NARC)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050271
First received: December 3, 2002
Last updated: May 17, 2012
Last verified: May 2012
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy

Resource links provided by NLM:


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

Enrollment: 27
Study Completion Date: January 2007
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050271

Locations
United States, California
Stanford CRS
Palo Alto, California, United States, 94305
United States, Georgia
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States, 30308
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
United States, Illinois
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States, 60612
Northwestern University CRS
Chicago, Illinois, United States, 60611-3015
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287-8106
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States, 63108-2138
United States, New York
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 90033-1079
Puerto Rico
Puerto Rico-AIDS CRS
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:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050271     History of Changes
Other Study ID Numbers: A5157, 10004, ACTG A5157
Study First Received: December 3, 2002
Last Updated: May 17, 2012
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

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

ClinicalTrials.gov processed this record on September 30, 2014