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Determining the Prevalence of HIV-Related Neurological Disorders in the Asia Pacific
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Institute of Mental Health (NIMH)
The Alfred
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00168246
  Purpose

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


Condition
HIV Infections
HIV Related Neurological Diseases

MedlinePlus related topics: AIDS Neurologic Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Convenience Sample, Prospective Study
Official Title: A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 600
Study Start Date: June 2005
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients are HIV infected
  • Patients are eighteen years or older
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168246

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Edwina Wright, Dr The Alfred Hospital
  More Information

Study ID Numbers: 77/05
Study First Received: September 13, 2005
Last Updated: February 26, 2007
ClinicalTrials.gov Identifier: NCT00168246  
Health Authority: United States: Federal Government;   Australia: National Health and Medical Research Council

Keywords provided by National Institute of Mental Health (NIMH):
HIV

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Nervous System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009