Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

NCT ID: NCT00476671

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

HIV infected adults with viral load \< 50 copies/ml on NNRTI based HAART

lumbar puncture, MRI, MRS

Intervention Type PROCEDURE

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

Interventions

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lumbar puncture, MRI, MRS

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hawaii

OTHER

Sponsor Role collaborator

SEARCH Research Foundation

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role collaborator

University of Missouri, Department of Psychology, Division of Neuroscience

OTHER

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jintanat Ananworanich, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration

Locations

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The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, , Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.hivnat.org

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Other Identifiers

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HIV-NAT 040

Identifier Type: -

Identifier Source: org_study_id

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