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NCT00168246 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00168246
Other study ID # 77/05
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 13, 2005
Last updated February 26, 2007
Start date June 2005

Study information
Verified date February 2007
Source National Institute of Mental Health (NIMH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentAustralia: National Health and Medical Research Council
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients are HIV infected

- Patients are eighteen years or older

Study Design

Observational Model: Natural History, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Alfred Hospital Melbourne Victoria

Sponsors (3)
Lead Sponsor Collaborator
National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS), The Alfred

Country where clinical trial is conducted

Australia, 

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