Overview

This trial is active, not recruiting.

Conditions hiv infections, hiv related neurological diseases
Sponsor National Institute of Mental Health (NIMH)
Collaborator The Alfred
Start date June 2005
Trial size 600 participants
Trial identifier NCT00168246, 77/05

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model natural history
Time perspective cross-sectional

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients are HIV infected - Patients are eighteen years or older

Additional Information

Official title A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
Principal investigator Edwina Wright, Dr
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH).