EUCTR2016-003741-29-ITActive, not recruitingPhase 1
MARAND-X Study: MARaviroc-based Treatment Switch in HIV-positive Patients with HAND: Consequences of Reducing Antiretroviral-associated NeurotoXicity - MARAND-X
A.S.L. TO 20 sites76 target enrollmentStarted: June 8, 2021Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 76
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 <50 copies/mL;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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;
Investigators
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