Trial record 1 of 12 for:    " May 18, 2007":" May 25, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00476671
First received: May 20, 2007
Last updated: October 19, 2008
Last verified: October 2008
  Purpose

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 Intervention
HIV Infections
Procedure: lumbar puncture, MRI, MRS

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • Neuropsychological testing score [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

PBMC and plasma


Estimated Enrollment: 100
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jintanat Ananworanich, HIV-NAT
ClinicalTrials.gov Identifier: NCT00476671     History of Changes
Other Study ID Numbers: HIV-NAT 040
Study First Received: May 20, 2007
Last Updated: October 19, 2008
Health Authority: Thailand: Ethical Committee

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014