Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079807
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2004-03-15
Brief Title:
Painful HIV Neuropathy and Alpha-Lipoic Acid
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Painful HIV Neuropathy Treatment With Alpha-Lipoic Acid
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV is associated with painful peripheral neuropathy Disability is often significant Alpha-Lipoic Acids antioxidant properties may have benefit in this condition
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 perday 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
This placebo-controlled study is designed to evaluate the effects of daily oral alpha-lipoic acid supplements 600mg three times perday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MannJ | None | None | None |