HIV-infection, HIV-associated neurocognitive disorders MedDRA version: 21.1 Level: LLT Classification code 10001516 Term: AIDS-dementia complex System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10002725 Term: Anti-HIV positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: CELSENTRI - 300 MG COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (PVC/ALU) 60 COMPRESSE
Product Name: CELSENTRI
Product Code: MARAVIROC
Pharmaceutical Form: Coated tablet
CAS Number: 37
Sponsors
A.S.L. TO 2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age above >18 years; • Confirmed HIV-positivity; • Diagnosed with HAND according to the Frascati Criteria; • On combination antiretroviral treatment; • No evidence of major resistance associated mutations on previous plasma or CSF samples; • Plasma and CSF HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • the use of drugs having major drug-to-drug interaction with maraviroc (for instance rifampicin); • the use of efavirenz- or darunavir-containing regimens at baseline; • confounding comorbidities that may influence or affect the diagnosis of HAND including developmental disability, history of traumatic brain injury or of cerebrovascular accident; • a previous diagnosis of central nervous system opportunistic, autoimmune, neurodegenerative or neoplastic disease; • severe untreated depression; • active alcohol or recreational substance abuse (in the previous 3 months); • not fluent in Italian or unable to complete the neurocognitive tests. • the presence of CXCR4 or dual mixed tropic virus;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The change in neurocognitive function in patients randomized to a less neurotoxic regimen (maraviroc, emtricitbaine, darunavir);Secondary Objective: The change in surrogate markers of cerebral function (MRI with resting state fMRI, EEG, lumbar puncture) in patients randomized to a less neurotoxic regimen (maraviroc, emtricitbaine, darunavir); The correlation of such effect to plasma and CSF concentrations of antiretorvirals.;Primary end point(s): 6-month variation in global deficit score in NPZ-8 complete neurocognitive tests according to the study arm;;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change in neuronal integrity, perfusion and connectivity using MRI and resting state fMRI in the two arms; change in EEG waves using a EEG with LIORETA software in the two arms; change in CSF HIV RNA in the two arms; change in CSF biomarkers (neuronal damage, immune activation and astrocytosis) in the two arms; change in intima media thickness in the two arms; change in serum TMA/TMAO in thw two arms; Association of changes in primary and secondary endpoints with plasma and CSF concentrations of antiretrovirals;Timepoint(s) of evaluation of this end point: 6 months; 6 months; 6 months; 6 months; 6 months; 6 months; 6 months | — |
Countries
Italy
Contacts
Public ContactCU 1p
A.S.L. TO2
Outcome results
None listed