Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000493640
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Asia Pacific NeuroAIDS Consortium (APNAC) Study
Scientific title
A cross-sectional study of HIV-related Neurological Disorders in Ten Countries of the Asia Pacific Region
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 615 0
HIV-related neurological diseases 616 0
Condition category
Condition code
Infection 688 688 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Neurological 689 689 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The is 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, cryptococal meningitis, lymphoma, PML and CMV encephalitis.
Intervention code [1] 638 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 839 0
1. To determine the prevalence of HIV-related neurocognitive impairment and ADC at the APNAC-10 sites
Timepoint [1] 839 0
Primary outcome [2] 840 0
2. To determine the prevalence of symptomatic peripheral sensory neuropathy at the APNAC-10 sites
Timepoint [2] 840 0
Primary outcome [3] 841 0
3. To determine the prevalence of central nervous system opportunistic infections and tumours at the APNAC-10 sites
Timepoint [3] 841 0
Secondary outcome [1] 1660 0
To determine the degree of cognitive impairment in patients presenting with HIV-related cognitive impairment at the APNAC-10 sites.
Timepoint [1] 1660 0
Secondary outcome [2] 1661 0
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.
Timepoint [2] 1661 0
Secondary outcome [3] 1662 0
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.
Timepoint [3] 1662 0
Secondary outcome [4] 1663 0
To compare the prevalence of HIV-related neurocognitive impairment and ADC between the APNAC-10 sitesTo describe the severity of symptoms of patients presenting with symptomatic peripheral sensory neuropathy at the APNAC-10 sites.
Timepoint [4] 1663 0
Secondary outcome [5] 1664 0
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.
Timepoint [5] 1664 0
Secondary outcome [6] 1665 0
To determine what proportion of symptomatic peripheral sensory neuropathy may be ascribed to HIV alone, to the use of nucleoside analogues.
Timepoint [6] 1665 0
Secondary outcome [7] 1666 0
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.
Timepoint [7] 1666 0
Secondary outcome [8] 1667 0
To compare the prevalence of symptomatic peripheral sensory neuropathy between the APNAC-10 sites.
Timepoint [8] 1667 0
Secondary outcome [9] 1668 0
To determine the prevalence of asymptomatic peripheral neuropathy.
Timepoint [9] 1668 0
Secondary outcome [10] 1669 0
To describe the presenting symptoms and signs of patients presenting with CNS OIs and tumours at the APNAC-10 sites.
Timepoint [10] 1669 0
Secondary outcome [11] 1670 0
To describe the neuroradiological findings of patients presenting with CNS OIs and tumours at the APNAC-10 sites.
Timepoint [11] 1670 0
Secondary outcome [12] 1671 0
To determine the serological, culture and other diagnostic test results of patients presenting with CNS OIs and tumours at the APNAC-10 sites.
Timepoint [12] 1671 0
Secondary outcome [13] 1672 0
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.
Timepoint [13] 1672 0
Secondary outcome [14] 1673 0
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.
Timepoint [14] 1673 0
Secondary outcome [15] 1674 0
To compare the prevalence of CNS OIs and tumours between the APNAC-10 sites.
Timepoint [15] 1674 0

Eligibility
Key inclusion criteria
Patients are HIV infected.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
30/03/2006
Date of last data collection
Anticipated
Actual
30/03/2006
Sample size
Target
600
Accrual to date
Final
658
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 764 0
Government body
Name [1] 764 0
National Institute of Mental Health
Country [1] 764 0
United States of America
Funding source category [2] 765 0
Government body
Name [2] 765 0
National Institute of Neurological Disorders and Stroke
Country [2] 765 0
United States of America
Primary sponsor type
Government body
Name
National Institute of Mental Health and National Institute of Neurological Disorders and Stroke
Address
Country
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2010 0
Alfred Hospital
Ethics committee address [1] 2010 0
Ethics committee country [1] 2010 0
Australia
Date submitted for ethics approval [1] 2010 0
Approval date [1] 2010 0
30/03/2005
Ethics approval number [1] 2010 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35846 0
Address 35846 0
Country 35846 0
Phone 35846 0
Fax 35846 0
Email 35846 0
Contact person for public queries
Name 9827 0
Dr. Edwina Wright
Address 9827 0
Infectious Diseases Department
The Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Melbourne VIC 3004
Country 9827 0
Australia
Phone 9827 0
+61 3 92766078
Fax 9827 0
+61 3 92762431
Email 9827 0
[email protected]
Contact person for scientific queries
Name 755 0
Dr. Edwina Wright
Address 755 0
Infectious Diseases Department
The Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Melbourne VIC 3004
Country 755 0
Australia
Phone 755 0
+61 3 92766078
Fax 755 0
+61 3 92762431
Email 755 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.