HIV Clinical Trial
Official title:
The Efficacy of Neuro-HAART in HIV Infected Individuals
Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related
complications despite the use of highly active antiretroviral therapy (HAART). Such
complications are termed HIV neurocognitive disorders (HAND) and comprise a spectrum from
asymptomatic neurocognitive impairment (ANI), through mild cognitive impairment (MCI) to
severe HIV dementia (HAD).
Prior to HAART approximately 30% of patients with advanced HIV disease had cognitive
impairment; with HAART the incidence of HAND has decreased but its prevalence increased. The
reasons for the ongoing development of cognitive impairment in HAART treated patients are
not clear. They might relate to virus induced brain injury prior to starting HAART, the
onset of a separate neurological process, toxicity related to HAART, or ongoing viral
infection in the brain.
It is clear that the ability of different antiretroviral drugs to penetrate the brain varies
but what is not established is whether these differences between drugs lead to different
neurological outcomes. The investigators propose to study HIV infected patients stable on
HAART for 12 months; subdividing the groups according to the brain penetrance of their drug
combination. Patients would undergo neuropsychological assessment and MRI brain scan at the
start of the study and after 12 months. At study initiation a lumbar puncture would be
performed so that drugs levels could be measured in CSF.
Differences in neuropsychological tests and MRI would be sought between treatment groups to
establish whether HAART with better CNS penetration is associated with better outcome and
fewer MRI changes.
n/a
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