NCT01434654: HANDobs

The Efficacy of Neuro-HAART in HIV Infected Individuals

Terminated Results posted Last updated 6 July 2016

What this trial tests

trial in HIV in 19 participants. Terminated before completion.

Timeline

1 September 2011

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	St Vincent's Hospital, Sydney
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	19
Start date	1 September 2011
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	2 locations across Australia

Conditions studied

• HIV — all drugs for HIV →

Sponsor

St Vincent's Hospital, Sydney

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Neurocognitive Functioning
  Time frame: Change from baseline Neuropsychological testing at 6 and 12 months
  Change in overall neurocognitive performance, defined as a global neurocognitive z-score, after a 12-month period of observation, between HIV positive patients taking antiretroviral regimens categorized as being either of high or low CNS penetration. To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, Standard Dev

Sponsor's own description

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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.