Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais

NCT00713752 | Completed DMC

• 1 other identifier: SEARCH002
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-negative

Outcome Measures

Primary Outcomes (1)

• To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education

  July 31, 2014

Secondary Outcomes (1)

• To estimate the learning effect on these test at 6 months and 12 months.

  July 31, 2014

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-negative Thais

You may qualify if:

• Age 20-69
• Male or female
• Negative HIV antibody at screening
• Have the ability to understand the study and signed the informed consent form

You may not qualify if:

• Head injury with loss of consciousness greater than 1 hour
• Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
• Severe illness within 30 days prior to entry
• Current or recent fevers or meningeal signs.
• History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
• 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.
• Known learning disability including dyslexia
• Confusion or other signs and symptoms of metabolic encephalopathy or delirium
• Focal neurological deficit on examination
• Examining physician's concern that participant may not be able to complete visit requirements.

Sponsors & Collaborators

• SEARCH Research Foundation: lead

Study Sites (1)

SEARCH Thailand

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Victor - Valcour, M.D.

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 11, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

TH (1)