Clinical trial NCT00168246: Determining the Prevalence of HIV-Related Neurological Disorders in the Asia Pacific
Official title: A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
HIV Related Neurological Diseases
Keywords: HIV
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
Collaborators: name: The Alfred
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2005-09-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: NATURAL_HISTORY
Time perspective: OTHER

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

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Edwina Wright, Dr
role: PRINCIPAL_INVESTIGATOR
References: