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Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

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.
ClinicalTrials.gov Identifier: NCT00476671
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : October 21, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Infections Procedure: lumbar puncture, MRI, MRS

Detailed Description:
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.

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official 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.
Study Start Date : March 2007
Primary Completion Date : April 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
HIV infected adults with viral load < 50 copies/ml on NNRTI based HAART
Procedure: lumbar puncture, MRI, MRS
lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia


Outcome Measures

Primary Outcome Measures :
  1. Neuropsychological testing score [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
PBMC and plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected adults with viral < 50 copies/ml on NNRTI based HAART
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476671


Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Sponsors and Collaborators
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
Investigators
Principal Investigator: Jintanat Ananworanich, MD, Ph.D The HIV Netherlands Australia Thailand Research Collaboration
More Information

Additional Information:
Responsible Party: Jintanat Ananworanich, HIV-NAT
ClinicalTrials.gov Identifier: NCT00476671     History of Changes
Other Study ID Numbers: HIV-NAT 040
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
neuropsychiatric
neurocognitive
psychiatric
HIV related dementia
MCMD
HIV-1
Prevalence, risk factors of neurocognitive impairment and psychiatric comorbidities in HIV-1 infected patients with undetectable viral load in the HAART era.
Treatment Experienced

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