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

March 17, 2009
May 2, 2011
August 2007
April 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00864292 on ClinicalTrials.gov Archive Site
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Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic

  • AIDS
  • Dementia
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  • HIV-infected, no dementia
    Patients with HIV-infection but no dementia
  • HIV-infected, dementia
    Patients with HIV-infection and dementia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00864292
SEARCH 001.1
No
Victor Valcour, John A. Burns School of Medicine, Honolulu, Hawaii
South East Asia Research Collaboration with Hawaii
Thai Red Cross AIDS Research Centre
Principal Investigator: Jintanat Ananworanich, PhD South East Asia Research Collaboration with Hawaii
South East Asia Research Collaboration with Hawaii
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP