NCT00476671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

May 20, 2007

Last Update Submit

July 15, 2020

Conditions

Keywords

neuropsychiatricneurocognitivepsychiatricHIV related dementiaMCMDHIV-1Prevalence, risk factors of neurocognitive impairment and psychiatric comorbidities in HIV-1 infected patients with undetectable viral load in the HAART era.Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological testing score

    1 day

Study Arms (1)

1

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

Procedure: lumbar puncture, MRI, MRS

Interventions

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, 10330, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMC and plasma

MeSH Terms

Conditions

HIV InfectionsAIDS Dementia Complex

Interventions

Spinal PunctureMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Jintanat Ananworanich, MD, Ph.D

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations