Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1
July 15, 2020 updated by: The HIV Netherlands Australia Thailand Research Collaboration
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10330
- The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV infected adults with viral < 50 copies/ml on NNRTI based HAART
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
HIV infected adults with viral load < 50 copies/ml on NNRTI based HAART
|
lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neuropsychological testing score
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jintanat Ananworanich, MD, Ph.D, The HIV Netherlands Australia Thailand Research Collaboration
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
May 20, 2007
First Submitted That Met QC Criteria
May 21, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIV-NAT 040
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.