HIV InfectionsNCT00713752
Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
An observational study of HIV Infections, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
The purpose of this study is to establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education (no certificate or primary school certificate, less than high school certificate or vocational certificate, high school certificate or higher vocational certificate or… Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 494 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2008to Dec 2013
- 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 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-negative Thais
Who may be able to join
- Age 20-69
- Male or female
- Negative HIV antibody at screening
- Have the ability to understand the study and signed the informed consent form
Who cannot join
- Head injury with loss of consciousness greater than 1 hour
- Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
- Severe illness within 30 days prior to entry
- Current or recent fevers or meningeal signs.
- History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
- active major depression will be excluded as well - patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
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- Known learning disability including dyslexia
- Confusion or other signs and symptoms of metabolic encephalopathy or delirium
- Focal neurological deficit on examination
- Examining physician's concern that participant may not be able to complete visit requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education (no certificate or primary school certificate, less than high school certificate or vocational certificate, high school certificate or higher vocational certificate or diploma, Bachelor degree or higher.
Read the detailed description
The Southeast Asia Research Collaboration with Hawaii (SEARCH) operates or collaborates on several neuroAIDS research protocols. To allow accurate interpretation of neuropsychological data, normative data that are obtained in a similar population are needed. Currently, there are limited such data available for this purpose.
The SEARCH 001 study evaluated the neurocognitive changes before and after highly active antiretroviral therapy in 30 HIV positive subjects and has also enrolled 230/300 proposed HIV-negative controls for this purpose. Normative data tables typically require many more individuals so that age and education strata can be established. We now propose to enroll up to 1000 HIV-seronegative individuals for this purpose.
- Conditions
- HIV Infections
- Keywords
- HIV-negative
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education
Measured: July 31, 2014
Secondary outcomes (1)
To estimate the learning effect on these test at 6 months and 12 months.
Measured: July 31, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc.Prof.Jintanat Ananworanich, M.D., SEARCH Research Foundation
- Investigators
- Victor - Valcour, M.D., Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713752
- Sponsor's protocol ID
- SEARCH002
- Status last verified
- Sep 2014
- First submitted
- 8 Jul 2008
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
- ClinicalTrials.gov ID
- NCT00713752
- Acronym / sponsor ID
- SEARCH002
- Conditions
- HIV Infections
- Keywords
- HIV-negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jul 2008 (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.
The purpose of this study is to establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education (no certificate or primary school certificate, less than high school certificate or vocational certificate, high school certificate or higher vocational certificate or diploma, Bachelor degree or higher.
Detailed description
The Southeast Asia Research Collaboration with Hawaii (SEARCH) operates or collaborates on several neuroAIDS research protocols. To allow accurate interpretation of neuropsychological data, normative data that are obtained in a similar population are needed. Currently, there are limited such data available for this purpose.
The SEARCH 001 study evaluated the neurocognitive changes before and after highly active antiretroviral therapy in 30 HIV positive subjects and has also enrolled 230/300 proposed HIV-negative controls for this purpose. Normative data tables typically require many more individuals so that age and education strata can be established. We now propose to enroll up to 1000 HIV-seronegative individuals for this purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-negative Thais
Key inclusion criteria (4 listed)
- Age 20-69
- Male or female
- Negative HIV antibody at screening
- Have the ability to understand the study and signed the informed consent form
Key exclusion criteria (10 listed)
- Head injury with loss of consciousness greater than 1 hour
- Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
- Severe illness within 30 days prior to entry
- Current or recent fevers or meningeal signs.
- History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
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
To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education
Time frame: July 31, 2014
1 secondary outcome
To estimate the learning effect on these test at 6 months and 12 months.
Time frame: July 31, 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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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.
Victor - Valcour, M.D. principal investigator
University of Hawaii
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, run by SEARCH Research Foundation at 1 site in Thailand.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 26 Sep 2014. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education (time frame: July 31, 2014). It is what the study was designed to measure, not a finding.
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 26 Sep 2014.