Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476671
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 |
ClinicalTrials.gov processed this record on March 03, 2015