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Establishing Normal Values for Neuropsychological Testing in HIV-Negative Thais
This study is currently recruiting participants.
Verified by South East Asia Research Collaboration with Hawaii, January 2008
Sponsored by: South East Asia Research Collaboration with Hawaii
Information provided by: South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT00713752
  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

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective

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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1000
Study Start Date: February 2008
Estimated Study Completion Date: December 2009
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, marajuana, 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 depresion that is controled 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713752

Contacts
Contact: Jintanat - Ananwaoranich, M.D. 662-254-2566 ext 1 jintanat.a@searchthailand.org
Contact: Benjawan - Boonchokchai, R.N. 662-254-2568-9 benjawan.b@searchthailand.org

Locations
Thailand, -
SEARCH Thailand Recruiting
Bangkok, -, Thailand, 10330
Contact: Benjawan - Boonchokchai, BNS     6622542566 ext 106     benjawan.b@searchthailand.org    
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Investigators
Principal Investigator: Victor - Valcour, M.D. University of Hawaii
Principal Investigator: Victor Valcour, MD University of Hawaii
Principal Investigator: Victor - Valcour, MD. University of Hawaii
  More Information

No publications provided

Responsible Party: SEARCH Thailand ( Benjawan Boonchokchai )
Study ID Numbers: SEARCH002
Study First Received: July 8, 2008
Last Updated: July 10, 2008
ClinicalTrials.gov Identifier: NCT00713752  
Health Authority: Thailand: Ministry of Public Health

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on February 12, 2009