NCT00079807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

3.4 years

First QC Date

March 15, 2004

Last Update Submit

April 21, 2008

Conditions

HIVPeripheral Neuropathy

Keywords

HIVPeripheral neuropathyAlpha-Lipoic AcidALAComplementary Therapies

Interventions

Alpha-Lipoic AcidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

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

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • John Mann, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 15, 2004

First Posted

March 16, 2004

Study Start

September 1, 2003

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(1)