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

SEARCH Research Foundation

Status: Completed

Conditions: AIDS; Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT00864292

SEARCH 001.1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

HIV-infected, no dementia

Description:

Patients with HIV-infection but no dementia

HIV-infected, dementia

Description:

Patients with HIV-infection and dementia