Status:
COMPLETED
HIV-1 Specific Immune Responses in Thai Individuals With HIV Dementia
Lead Sponsor:
SEARCH Research Foundation
Conditions:
HIV Infections
Eligibility:
All Genders
20+ years
Brief Summary
A total of 60 participants will be enrolled. They will be in 3 groups 1. ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV 2. ARV-naïve, HIV-positive ≥ 20 year of age w...
Detailed Description
This application focuses on the role of cellular immune responses in HIV dementia (HAD) versus non-HAD individuals in a cognitively characterized cohort followed for one year. Increasing evidence lin...
Eligibility Criteria
Inclusion
- Group Thai HAD individuals
- 20 years of age
- not currently receiving nor have ever received antiretroviral medications
- not explained by opportunistic infections or causes other than HIV on the basis of clinical assessment and neuropsychological testing and eligible for inclusion.
- Group Thai Non-HAD individuals
- will be matched with a seropositive Thai patient with similar age (same decade), education (less than high school degree, high school degree +/- some college, college degree +), gender, and CD4 group
- HIV positive
- not currently receiving nor have ever received antiretroviral medications.
- Group Thai Non-HAD individuals will be matched with a Thai seronegative patient by age (same decade), and education (less than high school degree, high school degree +/- some college, college degree+), and gender.
Exclusion
- Head injury with loss of consciousness greater than 1 hour
- Current or past illicit drug use (less then 5 years) or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics at either screening or entry.
- Inability to provide informed consent or lack of designated surrogate who can provide consent
- The following laboratory values:
- 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 to entry, persistent and active AIDS- defining opportunistic infection or autoimmune disease. Stable treated opportunistic infections on maintenance therapy, minor infections such as oral thrush and Kaposi's Sarcoma limited to the skin will be allowed.
- Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection.\*
- History of pre-existing neurologic disease to include stroke, multiple sclerosis
- History of psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, or post traumatic stress disorder. Patients with active major depression will be excluded as well - patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
- Known learning disability including dyslexia.
- Positive Hepatitis C serology (Hepatitic C Ab)
- Confusion or other signs and symptoms of metabolic encephalopathy or delirium
- Mass consistent with opportunistic infection or tumor on CT or MRI of the head, or focal neurological deficit on examination consistent with possible brain lesion.\*
- Other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin B12 deficiency or neurosyphilis.
- Pregnancy.
- Not willing to take an MRI.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00777426
Start Date
September 1 2008
End Date
October 1 2013
Last Update
September 26 2014
Active Locations (1)
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1
SEARCH Thailand
Bangkok, Bangkok, Thailand, 10330