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Painful HIV Neuropathy and Alpha-Lipoic Acid

This study has been completed.
Study NCT00079807.   Last updated on April 21, 2008.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Painful HIV Neuropathy and Alpha-Lipoic Acid
Official Title  Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid
Brief Summary

HIV is associated with painful peripheral neuropathy. Disability is often significant. Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.

Detailed Description

HIV is associated with painful distal peripheral polyneuropathy in up to 35-50% of those without AIDS and in more than 70% of those with advanced disease. The condition is progressive but may be halted with disease remission. Disability is often significant. Peripheral nerve axons and sensory neuron cell bodies in the dorsal root ganglia are the principal targets of the process leading to symptoms. Alpha-lipoic acid occurs naturally in every cell of the body. In high concentrations it acts as an anti-oxidant which regenerates other anti-oxidants and promotes glutathione synthesis. Clinical studies for diabetic neuropathy have shown significant benefit at daily oral doses that are well-tolerated.

This placebo-controlled study is designed to evaluate the effects of daily oral alpha-lipoic acid supplements (600mg, three times per/day) plus standard medical care in the treatment of painful HIV-associated neuropathy over a 24-week period in adult subjects. Possible benefits of the study include reduction in pain and disability, reduced use of medications, and enhanced cellular metabolism.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV
Peripheral Neuropathy
Intervention  Drug: Alpha-Lipoic Acid
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  60
Start Date  September 2003
Completion Date February 2007
Eligibility Criteria 

Inclusion Criteria:

  • HIV-seropositive
  • Distal peripheral sensory neuropathy as diagnosed by a neurologist with pain or paresthesia, with or without numbness or weakness
  • Able to understand and participate in protocol activities
  • Able to give informed consent
  • Under the care of a UNC ID Clinical physician for at least 2 months
  • Able to document pain characteristics, use of pain medications, and other assessment instruments and characteristics
  • On stable antiretroviral therapy (or none) for 12 weeks prior to enrollment
  • No changes in peripheral neuropathy pharmacologic treatment for 12 weeks prior to enrollment

Exclusion Criteria:

  • Any significant cognitive impairment or psychosis
  • Pregnancy or anticipated pregnancy (women of child-bearing potential must agree to use birth control for the duration of the study)
  • Undergoing any current treatment for malignancy, including chemotherapy or radiation therapy within the past year
  • Concurrent or prior use of a-LA
  • Known non-HIV risk factors for peripheral neuropathy, such as DM, B12/folate deficiency; thyroid dysfunction; hx of exposure to lead, mercury, arsenic, thallium (prior diagnostic tests permitted), other heavy metals or complex hydrocarbons
  • Use of metronidazole, isoniazid or other furantoins
  • Suspected or documented thiamin deficiency
  • Active alcoholism
  • Allergy to a-LA
  • Hx of 'significant' use of anti-oxidant supplements during the two months prior to study entry
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00079807
Organization ID R21 AT001775
Secondary IDs †† MannJ
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     John Mann, MD     The University of North Carolina, Chapel Hill    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date April 2008
First Received Date  March 15, 2004
Last Updated Date April 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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