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

February 26, 2007 updated by: National Institute of Mental Health (NIMH)

A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients are HIV infected
  • Patients are eighteen years or older

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
The Alfred

Investigators

  • Principal Investigator: Edwina Wright, Dr, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 26, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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