Status:
COMPLETED
Painful HIV Neuropathy and Alpha-Lipoic Acid
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
HIV
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 halte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00079807
Start Date
September 1 2003
End Date
February 1 2007
Last Update
April 22 2008
Active Locations (1)
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1
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7025