Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV
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ClinicalTrials.gov Identifier: NCT00782808
Recruitment Status :
First Posted : October 31, 2008
Last Update Posted : September 26, 2014
South East Asia Research Collaboration with Hawaii
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will be performed at SEARCH in real-time with less than one-week turn around time. All individuals will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will work with the primary care physician to facilitate initiation of standard ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.
To determine the long-term relationship between cognition and HIV DNA in circulating PBMCs and monocytes (CD14+ PBMCs) among patients initiating HAART for the first time [ Time Frame: After March 30, 2016 ]
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Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening. Consequently, all participants will have plasma CD4 counts at less than 250 cells.
HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening.
Consequently, all participants will have plasma CD4 counts at less than 250 cells.
Head injury with loss of consciousness greater than 1 hour or cognitive sequela
Current/past illicit drug use or positive drug screen for methamphetamines, amphetamines, or cocaine at screening or entry.
Any of the following laboratory abnormalities:
PT/PTT > the upper limit of normal (ULN) or INR > 1.1
Hemoglobin < 9.0 mg/dL
ALT > 5x ULN
serum creatinine > 2x ULN or creatinine clearance < 30 cc per min by Cockroft-Gault formula
Acute illness within 30 days prior, persistent and active AIDS-defining OI of any organ system or autoimmune disease.
Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection
CNS opportunistic infection, past or present (Patients diagnosed with opportunistic infection after CSF examination will be excluded from further analysis. In such a situation, an additional patient will be enrolled)
History of pre-existing neurologic disease to include stroke, multiple sclerosis or psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, major depression, or post traumatic stress disorder. Patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
Known learning disability including dyslexia or unable to read or write basic Thai
Positive Hepatitis C serology (Hepatitis C Ab)
Confusion or other signs and symptoms of metabolic encephalopathy or delirium
Other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin B12 deficiency or neurosyphilis
Pregnancy or metal objects that would preclude MRI