Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476671
• Other study ID #: HIV-NAT 040
• Status: Completed
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Chulalongkorn University, South East Asia Research Collaboration with Hawaii, University of Hawaii, University of Missouri, Department of Psychology, Division of Neuroscience

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological testing score		1 day

External Links

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