Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
A Randomised Controlled Clinical Trial of the Efficacy of HAART Intensification With Maraviroc in HIV Virally Suppressed Patients With Cognitive Impairment
HIV related cognitive impairment still occurs despite highly active antiretroviral therapy
(HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease;
leading to varying degrees of cognitive impairment, recently termed HIV associated
neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in
both blood and CSF.
Patients with HIV Associated Neurocognitive Disorders (HAND) who are virally suppressed in
both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral
therapy (HAART) regimen may have significant cognitive improvement with HAART intensification
with the medication Maraviroc; compared to those who remain on their existing regimen.
This study will be a prospective, interventional, randomised and unblinded controlled
clinical trial. The aim of this study will be to determine whether HAART intensification with
the medication Maraviroc, leads to significant improvement in HIV associated neurocognitive
disorders (HAND).
Patients with the recent progression (within 6 months) of HAND (validated by
neuropsychological assessment) on HAART, who are virally suppressed (<50 copies per ml) in
blood and CSF will be randomised to have their existing HAART regimen intensified with
Maraviroc, or not. The control arm will remain on their medication regimen as prescribed. The
target is to enrol 70 patients into the control group, and 70 patients into the Maraviroc
intensification group.
Patients will undergo baseline neuropsychological testing, MRI, blood tests, and
cerebrospinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the
effectiveness of adding Maraviroc, will include further neuropsychological assessment at 6
months, and neuropsychological assessment, MRI and CSF assessment again at 12 months.
Neuropsychological testing completed at 6 and 12 months will be completed by a "blind
assessor", in that they will have no knowledge of which arm (treatment or control) the
participant is enrolled in.
An evaluation (neuropsychological testing) will be performed should the patient deteriorate
during the course of the study, as recognised by the patient's managing physician.
At the end of the study protocol (12 months) the patient's HAART therapy will be managed by
their primary physician.
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