Efficacy of Neuro-HAART in Patients With HIV (HANDobs)
|First Received Date ICMJE||September 12, 2011|
|Last Updated Date||October 7, 2012|
|Start Date ICMJE||September 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Neurocognitive Function [ Time Frame: Change from baseline Neuropsychological testing, at 12 months ] [ Designated as safety issue: No ]
To compare the change in summary neuropsychological 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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01434654 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy of Neuro-HAART in Patients With HIV|
|Official Title ICMJE||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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
Cerbrospinal fluid and bloods
|Sampling Method||Non-Probability Sample|
HIV positive participants on HAART who attend outpatient primary care clinics.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||170|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Australia|
|NCT Number ICMJE||NCT01434654|
|Other Study ID Numbers ICMJE||09/192, COL114560|
|Has Data Monitoring Committee||No|
|Responsible Party||Bruce Brew, St Vincent's Hospital, Sydney|
|Study Sponsor ICMJE||St Vincent's Hospital, Sydney|
|Collaborators ICMJE||ViiV Healthcare|
|Information Provided By||St Vincent's Hospital, Sydney|
|Verification Date||October 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP