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

Dementia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864292
• Other study ID #: SEARCH 001.1
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: May 2, 2011
• Start date: August 2007
• Est. completion date: April 2011

Study information

• Verified date: March 2009
• Source: South East Asia Research Collaboration with Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS
• Dementia

Locations

Country	Name	City	State
Thailand	South East Asia Research Collaboration with Hawaii	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
South East Asia Research Collaboration with Hawaii	Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand,