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Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects

This study has been completed.
Sponsor:
Collaborator:
Thai Red Cross AIDS Research Centre
Information provided by:
South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00864292
First received: March 17, 2009
Last updated: May 2, 2011
Last verified: March 2009
History of Changes
  Purpose

Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.

At each visit, patients will undergo the following

  1. Assessment of function including activity of daily living questionnaire
  2. History of medical illnesses, medication history
  3. Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
  4. Neuropsychological assessment:
  5. Thai Depression Inventory.
  6. HIV viral load and storage of blood for proviral DNA level

Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.


Condition
AIDS
Dementia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Dementia HIV/AIDS
U.S. FDA Resources

Further study details as provided by South East Asia Research Collaboration with Hawaii:

Enrollment: 60
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected, no dementia
Patients with HIV-infection but no dementia
HIV-infected, dementia
Patients with HIV-infection and dementia

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864292

Locations
Thailand
South East Asia Research Collaboration with Hawaii
Bangkok, Thailand, 10330
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Thai Red Cross AIDS Research Centre
Investigators
Principal Investigator: Jintanat Ananworanich, PhD South East Asia Research Collaboration with Hawaii
  More Information

No publications provided

Responsible Party: Victor Valcour, John A. Burns School of Medicine, Honolulu, Hawaii
ClinicalTrials.gov Identifier: NCT00864292     History of Changes
Other Study ID Numbers: SEARCH 001.1
Study First Received: March 17, 2009
Last Updated: May 2, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 05, 2013