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Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00713752
First received: July 8, 2008
Last updated: September 25, 2014
Last verified: September 2014

July 8, 2008
September 25, 2014
February 2008
December 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00713752 on ClinicalTrials.gov Archive Site
To estimate the learning effect on these test at 6 months and 12 months. [ Time Frame: July 31, 2014 ] [ Designated as safety issue: No ]
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Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

HIV-negative Thais

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 20-69
  2. Male or female
  3. Negative HIV antibody at screening
  4. Have the ability to understand the study and signed the informed consent form

Exclusion Criteria:

  1. Head injury with loss of consciousness greater than 1 hour
  2. Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
  3. Severe illness within 30 days prior to entry
  4. Current or recent fevers or meningeal signs.
  5. History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
  6. 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.
  7. Known learning disability including dyslexia
  8. Confusion or other signs and symptoms of metabolic encephalopathy or delirium
  9. Focal neurological deficit on examination
  10. Examining physician's concern that participant may not be able to complete visit requirements.
Both
20 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00713752
SEARCH002
Yes
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
South East Asia Research Collaboration with Hawaii
Not Provided
Principal Investigator: Victor - Valcour, M.D. University of Hawaii
South East Asia Research Collaboration with Hawaii
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP