Painful HIV Neuropathy and Alpha-Lipoic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079807
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : April 22, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
HIV Peripheral Neuropathy Drug: Alpha-Lipoic Acid Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid
Study Start Date : September 2003
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00079807

United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7025
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: John Mann, MD University of North Carolina, Chapel Hill Identifier: NCT00079807     History of Changes
Other Study ID Numbers: R21AT001775 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2004    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Peripheral neuropathy
Alpha-Lipoic Acid
Complementary Therapies

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances