- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00713752
Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The Southeast Asia Research Collaboration with Hawaii (SEARCH) operates or collaborates on several neuroAIDS research protocols. To allow accurate interpretation of neuropsychological data, normative data that are obtained in a similar population are needed. Currently, there are limited such data available for this purpose.
The SEARCH 001 study evaluated the neurocognitive changes before and after highly active antiretroviral therapy in 30 HIV positive subjects and has also enrolled 230/300 proposed HIV-negative controls for this purpose. Normative data tables typically require many more individuals so that age and education strata can be established. We now propose to enroll up to 1000 HIV-seronegative individuals for this purpose.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bangkok, Thailand, 10330
- SEARCH Thailand
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 20-69
- Male or female
- Negative HIV antibody at screening
- Have the ability to understand the study and signed the informed consent form
Exclusion Criteria:
- Head injury with loss of consciousness greater than 1 hour
- Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
- Severe illness within 30 days prior to entry
- Current or recent fevers or meningeal signs.
- History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
- 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
- Confusion or other signs and symptoms of metabolic encephalopathy or delirium
- Focal neurological deficit on examination
- Examining physician's concern that participant may not be able to complete visit requirements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education
Tidsramme: July 31, 2014
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July 31, 2014
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To estimate the learning effect on these test at 6 months and 12 months.
Tidsramme: July 31, 2014
|
July 31, 2014
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Victor - Valcour, M.D., University of Hawaii
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SEARCH002
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