Painful HIV Neuropathy and Alpha-Lipoic Acid
Completed · Phase 1/Phase 2
Conditions studied: HIV, Peripheral Neuropathy
In brief
HIV is associated with painful peripheral neuropathy. Disability is often significant. Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.
Key facts
- Study ID
- NCT00079807
- Run by
- National Center for Complementary and Integrative Health (NCCIH)
- People needed
- 60
- Starts
- 2003-09-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2008-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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