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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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To estimate the learning effect on these test at 6 months and 12 months. [ Time Frame: July 31, 2014 ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

HIV-negative Thais

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713752

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

No publications provided

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
Study First Received: July 8, 2008
Last Updated: September 25, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by South East Asia Research Collaboration with Hawaii:
HIV-negative

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

ClinicalTrials.gov processed this record on November 20, 2014