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

NCT ID: NCT00168246

Last Updated: 2007-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections HIV Related Neurological Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

NATURAL_HISTORY

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients are HIV infected
* Patients are eighteen years or older
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Alfred

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edwina Wright, Dr

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

77/05

Identifier Type: -

Identifier Source: org_study_id