Study to develop neuropsycological assesmentvalues in normal populatio
- Registration Number
- CTRI/2012/01/002389
- Lead Sponsor
- ational Institute of Allergy and Infectious Diseases NIAID USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 2400
4.1Step 1: Inclusion Criteria
4.1.1Absence of HIV-1 infection, as documented by a negative result of any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 30 days of study entry.
NOTE: The term ¡§licensed¡¨ refers to a kit that has been certified or licensed by an oversight body within that country and validated internally.
4.1.2Presented for HIV testing, at any location, within the last 30 days.
4.1.3Normal developmental history.
4.1.4Karnofsky performance score ?d 90 within 15 days prior to study entry.
4.1.5Men and women age ?d 18 years at study entry.
4.1.6Ability to provide the number of completed years of education.
4.1.7Ability and willingness of participant to provide informed consent.
4.3Step 2: Inclusion Criteria
4.3.1Absence of HIV-1 infection, as documented by a negative result from any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 30 days of Step 2 enrollment.
NOTE: The term ¡§licensed¡¨ refers to a kit that has been certified or licensed by an oversight body within that country and validated internally.
4.3.2 Completed Step 1 registration, assessments, and evaluations.
4.3.3 Willingness and ability to complete a second visit.
4.2Step 1: Exclusion Criteria
4.2.1Prior antiretroviral therapy.
4.2.2 Current illness that in the opinion of the investigator is likely to have an impact on neurological or neurocognitive functioning.
4.2.3Current use of medication that in the opinion of the investigator is likely to alter mental status or neurocognitive functioning including, but not limited to, sedative hypnotics, benzodiazepines, opioid analgesics, barbiturates, antipsychotics, or anticholinergics.
4.2.4History of physical illness or neurological, psychiatric, or developmental disorder that in the opinion of the investigator is likely to have an impact on the participant?s neurocognitive functioning, including, but not limited to, dementia, neurosyphilis, CNS tuberculosis, CNS mass lesions, stroke, epilepsy, head trauma, or transient ischemic attack.
4.2.5Active drug or alcohol use or dependence that interferes with social interactions, work, or other areas of functioning.
4.2.6Serious illness requiring systemic treatment and/or hospitalization within 15 days prior to study entry.
4.2.7Employment at the ACTG research clinic.
4.4Step 2: Exclusion Criteria
4.4.1Since Step 1 study visit, physical, neurological, or psychiatric illness, that in the opinion of the investigator is likely to have an impact on the participant?s neurocognitive functioning, including, but not limited to dementia, neurosyphilis, CNS tuberculosis, CNS mass lesions, stroke, epilepsy, head trauma, or transient ischemic attack.
4.4.2Active drug or alcohol use or dependence that interferes with social interactions, work, or other areas of functioning.
4.4.3Serious illness requiring systemic treatment and/or hospitalization within 15 days prior to Step 2 entry.
4.4.4Current use of medication that in the opinion of the investigator is likely to alter mental status or neurocognitive functioning including, but not limited to, sedative hypnotics, benzodiazepines, opioid analgesics, barbiturates, antipsychotics, or anticholinergics.
4.4.5Employment at the ACTG research clinic.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method