Status:
UNKNOWN
Neuroinflammation and Neurodegeneration in HIV-positive Subjects Switched and Initially Treated With INSTI
Lead Sponsor:
University of Novi Sad
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV I Infection
HIV Associated Lipodystrophy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
Since the HIV changed its course to the chronic disease, high incidence of metabolic syndrome both in HIV positive and negative subjects has become an issue. Given the successful peripheral suppressio...
Detailed Description
Serbia is low income country with epidemiology of HIV infection resembling those in developed countries, with average age of patients around 50 years and majority of them being the MSM population. Ano...
Eligibility Criteria
Inclusion
- Male (in order to eliminate the hormonal influences on the levels of brain metabolites),
- older than 18 years,
- HIV seropositivity confirmed on PCR testing,
- undetectable viral load for over one year,
- conventional magnetic resonance imaging (MRI) normal.
- In group I, the additional criterion would be stable cART not containing INSTI for over one year.
- In group II, the inclusion criteria will be the INSTI base regimen introduced at least one year prior to imaging.
Exclusion
- active infiltrative or infective/opportunistic neurological illness,
- chronic neurological diseases (multiple sclerosis, vascular and non-vascular dementia, other neurodegenerative conditions),
- active abuse of narcotic drugs,
- hepatitis B or C coinfection,
- deep white matter lesions (focal or diffuse, such as lacunar stroke, leukoaraiosis, infiltrative or infective foci, metastases etc.),
- International HIV Dementia Scale (IHDS) score \<10 (only neuro-asymptomatic subjects would be included in the study), and
- contraindications for MRI examination
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04887675
Start Date
May 1 2021
End Date
October 1 2022
Last Update
December 1 2021
Active Locations (1)
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1
Faculty of Medicine, University of Novi Sad
Novi Sad, Serbia, 21000