Painful HIV Neuropathy and Alpha-Lipoic Acid

HIV Clinical Trial

Official title:

Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079807
• Other study ID #: R21AT001775
• Secondary ID: MannJ
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 15, 2004
• Last updated: April 21, 2008
• Start date: September 2003
• Est. completion date: February 2007

Study information

• Verified date: April 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Alpha-Lipoic Acid

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,