Status:
COMPLETED
Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV
Lead Sponsor:
SEARCH Research Foundation
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
HIV Infections
Eligibility:
All Genders
20+ years
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00782808
Start Date
March 1 2009
End Date
April 1 2014
Last Update
September 26 2014
Active Locations (1)
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1
SEARCH Thailand
Bangkok, Thailand