Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X)

• Status: Terminated
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Neurocognitive disorders are still highly prevalent in the HAART era; despite a dramatic reduction in dementia cases, 15-50% of patients may develop mild or asymptomatic neurocognitive disorders (HIV-associated neurocognitive disorders, HAND).

Among other hypothesis neurotoxicity of antiretrovirals has been postulated but its impact is unknown.

Our hypothesis is that using drugs with reduced in vitro neurotoxicity may improve cognition in HIV-positive patients withHAND.

76 patients with HAND will be randomized to either continue their treatment or switch to emtricitabine, darunavir/cobicistat, maraviroc. Patients will be re-tested 6 months later.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Giovanni Di Perri
• Treatments: Cobicistat; Darunavir; Emtricitabine; Maraviroc

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 HIV RNA <50 copies/mL;

• CSF HIV RNA <50 copies/mL;

• R5-tropic virus as detected by a genotype or phenotype based test before starting HAART or genotype-based test performed on HIV DNA in the previous 12 months;

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.