Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1 - Full Text View

Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1

This study is currently recruiting participants.
Verified by The HIV Netherlands Australia Thailand Research Collaboration, May 2007

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
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476671

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

MedlinePlus related topics:

AIDS Dementia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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.

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

Biospecimen Description:

PBMC and plasma

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2008
Estimated 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476671

Contacts


Contact: Jintanat Ananworanich, MD, Ph.D	662-652-3040	jintanat.a@hivnat.org

Locations


Thailand
	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Recruiting
	Bangkok, Thailand, 10330
	Contact: Jintanat Ananworanich, MD, Ph.D 662-652-3040 jintanat.a@hivnat.org
	Principal Investigator: Jintanat Ananworanich, MD, Ph.D

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

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

Responsible Party:	HIV-NAT ( Jintanat Ananworanich )
Study ID Numbers:	HIV-NAT 040
First Received:	May 20, 2007
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00476671
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

AIDS Dementia Complex

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Dementia

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 10, 2008