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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Alfred
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00168246
First received: September 13, 2005
Last updated: February 26, 2007
Last verified: February 2007
  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

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2014