Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X) (NCT03163277) | Clinical Trial Compass
TerminatedPhase 4
Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X)
Stopped: Sloww accrual and COVID-19 related problems (impossible to perform LPs)
Italy38 participantsStarted 2017-05-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-month variation in global deficit score in NPZ-8 complete neurocognitive tests according to the study arm;