Clinical Trials


Painful HIV Neuropathy and Alpha-Lipoic Acid

This study has been completed
National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party)
National Center for Complementary and Integrative Health (NCCIH) Identifier

First received: March 15, 2004
Last updated: April 21, 2008
Last Verified: April 2008
History of Changes


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

Condition Intervention Phase
Peripheral Neuropathy

Drug : Alpha-Lipoic Acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Enrollment: 60
Study Start Date: September 2003
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

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.



Ages Eligible for Study: 18 Years and older  
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

contacts and locations

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 identifier: 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
More Information

More Information

Responsible Party: National Center for Complementary and Integrative Health (NCCIH) Identifier: NCT00079807   History of Changes  
Other Study ID Numbers: R21AT001775  
Study First Received: March 15, 2004  
Last Updated: April 21, 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
Thioctic Acid processed this data on June 02, 2020
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