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Painful HIV Neuropathy and Alpha-Lipoic Acid

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00079807
First received: March 15, 2004
Last updated: April 21, 2008
Last verified: April 2008

March 15, 2004
April 21, 2008
September 2003
February 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00079807 on ClinicalTrials.gov Archive Site
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Painful HIV Neuropathy and Alpha-Lipoic Acid
Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV
  • Peripheral Neuropathy
Drug: Alpha-Lipoic Acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00079807
R21 AT001775, MannJ
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: John Mann, MD University of North Carolina, Chapel Hill
National Center for Complementary and Alternative Medicine (NCCAM)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP