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Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476671
First Posted: May 22, 2007
Last Update Posted: October 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Hawaii
South East Asia Research Collaboration with Hawaii
Chulalongkorn University
University of Missouri, Department of Psychology, Division of Neuroscience
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
May 20, 2007
May 22, 2007
October 21, 2008
March 2007
April 2008   (Final data collection date for primary outcome measure)
Neuropsychological testing score [ Time Frame: 1 day ]
Not Provided
Complete list of historical versions of study NCT00476671 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1
Prevalence and Risk Factors of HIV-Associated Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1 Infected Thai Individuals With Undetectable Viral Load in the HAART Era.
To assess the prevalence and risk factors of neurocognitive impairment and psychiatric comorbidities in HIV infected patients who have undetectable viral load, have been on HAART for at least 1 year and have no history of CNS infection.
To understand how to prevent and treat HIV-associated neurocognitive impairment and psychiatric comorbidities in HIV-infected Thai individuals who don't have current AIDS related illness or current and prior central nervous system (CNS) infection, and have been well treated with HAART with undetectable HIV RNA.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
PBMC and plasma
Non-Probability Sample
HIV infected adults with viral < 50 copies/ml on NNRTI based HAART
HIV Infections
Procedure: lumbar puncture, MRI, MRS
lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia
1
HIV infected adults with viral load < 50 copies/ml on NNRTI based HAART
Intervention: Procedure: lumbar puncture, MRI, MRS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Evidence of HIV infection (confirmed positive ELISA and documented history of measurable HIV RNA)
  • Age > 18 years old
  • Plasma HIV RNA of < 50 copies/ml within 3 months prior to screening
  • Have been on only NNRTI-based HAART regimen for the entire duration and for at least1 year.

Exclusion Criteria:

  • Current AIDS defining illnesses
  • Current or history of previous CNS infection.
  • Head injury with loss of consciousness greater than 1 hour
  • Acute illness within 30 days prior to entry that, in the opinion of investigators, would prevent patients from completing the protocol required procedures.
  • Known learning disability including dyslexia
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00476671
HIV-NAT 040
Yes
Not Provided
Not Provided
Jintanat Ananworanich, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • University of Hawaii
  • South East Asia Research Collaboration with Hawaii
  • Chulalongkorn University
  • University of Missouri, Department of Psychology, Division of Neuroscience
Principal Investigator: Jintanat Ananworanich, MD, Ph.D The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
October 2008