Study of the use of anti_HIV drugs with reduced neuronal toxicity (including maraviroc) in patients with neurocogntive disorders

Phase 1

• Conditions: HIV-infection, HIV-associated neurocognitive disorders; MedDRA version: 21.1Level: LLTClassification code 10001516Term: AIDS-dementia complexSystem Organ Class: 100000004862; MedDRA version: 20.0Level: LLTClassification code 10002725Term: Anti-HIV positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-003741-29-IT
• Lead Sponsor: A.S.L. TO 2

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified