Painful HIV Neuropathy and Alpha-Lipoic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid|
|Study Start Date:||September 2003|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079807
|United States, North Carolina|
|University of North Carolina Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7025|
|Principal Investigator:||John Mann, MD||University of North Carolina, Chapel Hill|