Painful HIV Neuropathy and Alpha-Lipoic Acid

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Thioctic Acid

Criteria

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