Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168246
Status:
UNKNOWN
Last Update Posted:
2007-02-27
First Post:
2005-09-13
Brief Title:
Determining the Prevalence of HIV-Related Neurological Disorders in the Asia Pacific
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the prevalence of HIV-related neurological disorders in the countries of the Asia-Pacific Region
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None