Determining the Prevalence of HIV-Related Neurological Disorders in the Asia Pacific

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00168246
Collaborator
The Alfred (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
600
1

Study Details

Study Description

Brief Summary

This study will determine the prevalence of HIV-related neurological disorders in the countries of the Asia-Pacific Region.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This a cross-sectional study to determine the prevalence of HIV-related Neurological Disorders in the countries of the Asia-Pacific Region. Researchers will visit each country site for a period of 2-3 weeks and work with local investigators. Outpatients will be evaluated once-only for the presence of HIV-related symptomatic peripheral neuropathy and HIV-related Neurocognitive Impairment. Inpatients at the sites will be evaluated once-only for the presence of HIV dementia, cerebral toxoplasmosis, cerebral tuberculosis, cryptococcal meningitis, lymphoma, PML and CMV encephalitis.

    The Primary outcomes are:
    1. To determine the prevalence of HIV-related neurocognitive impairment and ADC at the APNAC-10 sites

    2. To determine the prevalence of symptomatic peripheral sensory neuropathy at the APNAC-10 sites

    3. To determine the prevalence of central nervous system opportunistic infections and tumours at the APNAC-10 sites

    The secondary outcomes are:

    To determine the degree of cognitive impairment in patients presenting with HIV-related cognitive impairment at the APNAC-10 sites

    • To determine the CD4 cell counts, HIV viral loads HIV viral loads and prior AIDS defining illnesses (ADIs) of patients presenting with HIV-related neurocognitive impairment and ADC at the APNAC-10 sites

    • To compare the prevalence of HIV-related neurocognitive impairment and ADC at the APNAC-10 sites to the published pre-HAART prevalence of these conditions in developed countries

    • To compare the prevalence of HIV-related neurocognitive impairment and ADC between the APNAC-10 sites

    • To describe the severity of symptoms of patients presenting with symptomatic peripheral sensory neuropathy at the APNAC-10 sites

    • To determine the CD4 cell counts, HIV viral loads HIV viral loads and prior ADIs of patients presenting with symptomatic peripheral sensory neuropathy at the APNAC-10 sites

    • To determine what proportion of symptomatic peripheral sensory neuropathy may be ascribed to HIV alone, to the use of nucleoside analogues

    • To compare the prevalence of symptomatic peripheral sensory neuropathy at the APNAC-10 sites to the published pre-HAART prevalence of these conditions in developed countries

    • To compare the prevalence of symptomatic peripheral sensory neuropathy between the APNAC-10 sites

    • To determine the prevalence of asymptomatic peripheral neuropathy

    • To describe the presenting symptoms and signs of patients presenting with CNS OIs and tumours at the APNAC-10 sites

    • To describe the neuroradiological findings of patients presenting with CNS OIs and tumours at the APNAC-10 sites

    • To determine the serological, culture and other diagnostic test results of patients presenting with CNS OIs and tumours at the APNAC-10 sites

    • To determine the CD4 cell counts, HIV viral loads and prior ADIs of patients presenting with CNS OIs and tumours at the APNAC-10 sites

    • To compare the prevalence of CNS OIs and tumours at the APNAC-10 sites to the published pre-HAART prevalence of these conditions in developed countries

    • To compare the prevalence of CNS OIs and tumours between the APNAC-10 sites

    Study Design

    Study Type:
    Observational
    Observational Model:
    Natural History
    Time Perspective:
    Other
    Official Title:
    A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
    Study Start Date :
    Jun 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Inclusion Criteria:
      • Patients are HIV infected

      • Patients are eighteen years or older

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Alfred Hospital Melbourne Victoria Australia 3004

      Sponsors and Collaborators

      • National Institute of Mental Health (NIMH)
      • The Alfred
      • National Institute of Neurological Disorders and Stroke (NINDS)

      Investigators

      • Principal Investigator: Edwina Wright, Dr, The Alfred

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00168246
      Other Study ID Numbers:
      • 77/05
      First Posted:
      Sep 15, 2005
      Last Update Posted:
      Feb 27, 2007
      Last Verified:
      Feb 1, 2007
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Feb 27, 2007