Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by South East Asia Research Collaboration with Hawaii.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00713752
First received: July 8, 2008
Last updated: April 29, 2011
Last verified: January 2008

July 8, 2008
April 29, 2011
February 2008
July 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00713752 on ClinicalTrials.gov Archive Site
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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.
 
Recruiting
440
October 2012
July 2012   (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: Jintanat - Ananwaoranich, M.D. 662-254-2566 ext 1 jintanat.a@searchthailand.org
Contact: Somporn - Tipsuk, BNS 662-254-2568-9 ext 107 somporn.t@searchthailand.org
Thailand
 
NCT00713752
SEARCH002
Yes
Somprartthana Rattanamanee, SEARCH Thailand
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
January 2008

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