Epidermal Nerve Fiber Density, Fat and Mitochondrial Parameters in Thai HIV+ Patients on d4T and HIV- Patients

NCT01178684 | Completed

• 1 other identifier: SEARCH 014
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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 reference norm for Thai HIV-positive subjects. In particular, comparison of ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai HIV-positive subjects prior to highly active antiretroviral therapy (HAART) will allow examination of the effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on long-term d4T (stavudine) with and without neuropathy will also provide reference ENFD values at the extremes of the disease process i.e. extent of ENFD decrease in subjects with d4T-induced symptomatic neuropathy and in subjects completely free of disease despite d4T treatment for comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003 study.

Conditions

HIV

Keywords

ENFD; epidermal nerve fiber density; HIV; HIV-infection

Outcome Measures

Primary Outcomes (2)

• Number of nerves in the skin

  To compare differences in ENFD between the 4 groups * group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy * group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy * group 3: HIV-negative subjects without peripheral neuropathy * group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy

  Baseline

• Condition of lipoatrophy

  To compare differences lipoatrophy between the 4 groups * group 1: HIV-positive subjects on long-term d4T with symptomatic peripheral neuropathy * group 2: HIV-positive subjects on long-term d4T without peripheral neuropathy * group 3: HIV-negative subjects without peripheral neuropathy * group 4: HIV-positive subjects on long-term d4T with asymptomatic peripheral neuropathy

  Baseline

Secondary Outcomes (3)

• Mitochondrial parameters

  Baseline

• Intracellular concentrations of d4T triphosphate

  Baseline

• HIV DNA in peripheral blood mononuclear cell (PBMC)

  Baseline

Study Arms (4)

1: HIV-pos on d4T with neuropathy

2: HIV-pos on d4T without neuropathy

3: HIV-neg without peripheral neuropathy

4 HIV-pos on d4T with asymtomatic neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seventy five HIV-positive patients on long-term d4T treatment (25 with symptomatic peripheral neuropathy, 25 without peripheral neuropathy and 25 with asymptomatic peripheral neuropathy) and 50 HIV-negative subjects without peripheral neuropathy will be recruited from the Thai Red Cross AIDS Research Centre and the Queen Savang Vadhana Memorial Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• University of Hawaii: collaborator

Study Sites (1)

Thai Red Cross AIDS Research Centre

Bangkok, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma PBMC Urine CBC

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jintanat Ananworanich, MD, PhD

  SEARCH Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Jintanat Ananworanich, MD,PhD

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: August 10, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

TH (1)