Status:
COMPLETED
Epidermal Nerve Fiber Density, Fat and Mitochondrial Parameters in Thai HIV+ Patients on d4T and HIV- Patients
Lead Sponsor:
SEARCH Research Foundation
Collaborating Sponsors:
University of Hawaii
Conditions:
HIV
Eligibility:
All Genders
18+ years
Brief Summary
This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used as appropriate...
Detailed Description
The range of changes in epidermal nerve fiber density (ENFD), subcutaneous fat, and mitochondrial function induced by stavudine (d4T)-based therapy is currently not known, globally or specifically in ...
Eligibility Criteria
Inclusion
- Group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy
- Documented HIV-1 infection
- Age ≥ 18 years old
- Has Thai national identification card
- Subject on d4T treatment with symptoms of neuropathy which developed after start of d4T therapy
- Evidence of symptomatic persistent symptoms of pain, tingling or numbness of lower extremities AND bilateral lower extremity neuropathy on exam at entry.
- Subject understands the study and is able to sign informed consent
- HIV RNA by PCR \< 50 copies/mL
Exclusion
- Treatment with concomitant medications (other than d4T) or having conditions (e.g. compressive neuropathy, diabetes, vitamin B12 deficiency, excessive alcohol intake meeting substance dependence criteria by DSM-IV, hepatitis C infection) known to cause neuropathy
- History of allergy to any anesthetic medications
- Pregnancy
- Group 2 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy.
- Group 3 subjects will meet the same criteria described above for group 1 subjects, but will NOT have symptoms OR signs of neuropathy and will have documented
- Group 4 subjects will meet the same criteria described above for group 1 subject, but will have evidence of symptomatic persistent symptoms of pain, tingling or numbness of lower extremities.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01178684
Start Date
May 1 2010
End Date
December 1 2012
Last Update
September 26 2014
Active Locations (1)
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1
Thai Red Cross AIDS Research Centre
Bangkok, Thailand