Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

Completed

• Conditions: HIV Infections
• Interventions: Procedure: lumbar puncture, MRI, MRS

• Registration Number: NCT00476671
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2008-04
• Study Completion: 2008-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	lumbar puncture, MRI, MRS	HIV infected adults with viral load \< 50 copies/ml on NNRTI based HAART

Primary Outcome Measures

Name	Time	Method
Neuropsychological testing score	1 day

Trial Locations

Locations (1)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT); 🇹🇭 Bangkok, Thailand