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OpenTrials
Completed

NCT Number: NCT00476671

Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar puncture, MRI, MRS

Procedure

lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia

Primary outcomes

  1. Neuropsychological testing score

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Chulalongkorn University
  • SEARCH Research Foundation
  • University of Hawaii
  • University of Missouri, Department of Psychology, Division of Neuroscience

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 22, 2007
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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