HIV InfectionsNCT00168246
Determining the Prevalence of HIV-Related Neurological Disorders in the Asia Pacific
An observational study of HIV Infections and HIV Related Neurological Diseases, run by National Institute of Mental Health (NIMH) at 1 site in Australia.
Trial summary
This study will determine the prevalence of HIV-related neurological disorders in the countries of the Asia-Pacific Region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV Related Neurological Diseases
- How many people
- 600 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients are HIV infected
- Patients are eighteen years or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
This study will determine the prevalence of HIV-related neurological disorders in the countries of the Asia-Pacific Region.
Read the 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:
- To determine the prevalence of HIV-related neurocognitive impairment and ADC at the APNAC-10 sites
- To determine the prevalence of symptomatic peripheral sensory neuropathy at the APNAC-10 sites
- 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
- HIV Infections, HIV Related Neurological Diseases
- Keywords
- HIV
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Alfred, National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- Edwina Wright, Dr, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168246
- Sponsor's protocol ID
- 77/05
- Status last verified
- Feb 2007
- First submitted
- 13 Sep 2005
- Last updated
- 27 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of HIV-Related Neurological Disorders in Ten Countries of the Asia Pacific Region
- ClinicalTrials.gov ID
- NCT00168246
- Acronym / sponsor ID
- 77/05
- Conditions
- HIV Infections, HIV Related Neurological Diseases
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- The Alfred, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the prevalence of HIV-related neurocognitive impairment and ADC at the APNAC-10 sites
- To determine the prevalence of symptomatic peripheral sensory neuropathy at the APNAC-10 sites
- 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 design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are HIV infected
- Patients are eighteen years or older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwina Wright, Dr principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Related Neurological Diseases, run by National Institute of Mental Health (NIMH) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.