Painful HIV Neuropathy and Alpha-Lipoic Acid

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Peripheral Neuropathy

HIV

Treatments

Drug: Alpha-Lipoic Acid

Study type

Interventional

Funder types

NIH

Identifiers

NCT00079807

MannJ

R21AT001775

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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