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

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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Key information

Conditions

AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Brain Diseases Central Nervous System Diseases Communicable Diseases Dementia Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Nervous System Diseases Neurocognitive Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

South East Asia Research Collaboration with Hawaii

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

SEARCH Research Foundation

Other

Collaborators

Thai Red Cross AIDS Research Centre

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Mar 18, 2009
Registry last updated: May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed