Painful HIV Neuropathy and Alpha-Lipoic Acid - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00079807

Purpose

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

Condition	Intervention	Phase
HIV Peripheral Neuropathy	Drug: Alpha-Lipoic Acid	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid

Resource links provided by NLM:

MedlinePlus related topics: AIDS Peripheral Nerve Disorders

Drug Information available for: Thioctic Acid

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	60
Study Start Date:	September 2003
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079807

Locations

United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7025

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

John Mann, MD

The University of North Carolina, Chapel Hill

More Information

No publications provided

Study ID Numbers:	R21 AT001775, MannJ
Study First Received:	March 15, 2004
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00079807 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

HIV
Peripheral neuropathy
Alpha-Lipoic Acid
ALA
Complementary Therapies

Additional relevant MeSH terms:

Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Protective Agents

Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Vitamins
Micronutrients
Thioctic Acid

ClinicalTrials.gov processed this record on November 22, 2009