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Painful HIV Neuropathy and Alpha-Lipoic Acid

Primary Purpose

HIV, Peripheral Neuropathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alpha-Lipoic Acid
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Peripheral neuropathy, Alpha-Lipoic Acid, ALA, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of North Carolina Chapel Hill

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 15, 2004
Last Updated
April 21, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00079807
Brief Title
Painful HIV Neuropathy and Alpha-Lipoic Acid
Official Title
Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
HIV is associated with painful peripheral neuropathy. Disability is often significant. Alpha-Lipoic Acid's 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Peripheral Neuropathy
Keywords
HIV, Peripheral neuropathy, Alpha-Lipoic Acid, ALA, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alpha-Lipoic Acid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mann, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States

12. IPD Sharing Statement

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Painful HIV Neuropathy and Alpha-Lipoic Acid

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