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Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais

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ClinicalTrials.gov Identifier: NCT00713752
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : September 26, 2014
Information provided by (Responsible Party):

Study Description
Brief 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 diploma, Bachelor degree or higher.

Condition or disease
HIV Infections

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

Study Type : Observational
Actual Enrollment : 494 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2008
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education [ Time Frame: July 31, 2014 ]

Secondary Outcome Measures :
  1. To estimate the learning effect on these test at 6 months and 12 months. [ Time Frame: July 31, 2014 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV-negative Thais

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713752

SEARCH Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Principal Investigator: Victor - Valcour, M.D. University of Hawaii
More Information

Responsible Party: Assoc.Prof.Jintanat Ananworanich, M.D., Assoc.Prof., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT00713752     History of Changes
Other Study ID Numbers: SEARCH002
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014

Keywords provided by Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases