Painful HIV Neuropathy and Alpha-Lipoic Acid
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Painful HIV Neuropathy: Treatment With Alpha-Lipoic Acid |
| 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) |
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 |
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| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00079807 History of Changes |
| Other Study ID Numbers: | R21 AT001775, MannJ |
| Study First Received: | March 15, 2004 |
| Last Updated: | April 21, 2008 |
| 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:
|
Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013