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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01434654




Registration number
NCT01434654
Ethics application status
Date submitted
12/09/2011
Date registered
15/09/2011
Date last updated
9/08/2016

Titles & IDs
Public title
Efficacy of Neuro-HAART in Patients With HIV
Scientific title
The Efficacy of Neuro-HAART in HIV Infected Individuals
Secondary ID [1] 0 0
COL114560
Secondary ID [2] 0 0
09/192
Universal Trial Number (UTN)
Trial acronym
HANDobs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non Neuro-HAART (low CNS penetrance) - Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.

Neuro-HAART (high CNS penetrance) - Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Neurocognitive Functioning
Timepoint [1] 0 0
Change from baseline Neuropsychological testing at 6 and 12 months
Secondary outcome [1] 0 0
Change in MRS Cerebral Metabolite Ratios in Basal Ganglia
Timepoint [1] 0 0
Baseline and 12 months
Secondary outcome [2] 0 0
Change in MRS Cerebral Metabolite Ratios in Frontal White Matter
Timepoint [2] 0 0
Baseline and 12 months
Secondary outcome [3] 0 0
Cerebrospinal Fluid
Timepoint [3] 0 0
Baseline to 12 Months

Eligibility
Key inclusion criteria
- HIV positive with nadir cluster of differentiation 4 (CD4) count <350 /microlitre (uL)

- Taking HAART with CNS Penetration Effectiveness (CPE) score of either =7.0 or =7.5 for
1 year or more. Changes in antiretrovirals (ARVs) within the last 12 months are
allowed so long as the CPE score does not lead to a change groups

- Plasma HIV viral load <50 copies / mL for preceding 12 months or longer

- Informed consent given by participant or legally appointed guardian
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-HIV related neurological disorders and active CNS opportunistic infection as
assessed by full blood count, electrolytes, creatinine, glucose, liver function tests,
cryptococcal antigen, venereal disease reaction level (VDRL), MRI brain scan and
cerebrospinal fluid analyses for cell count, protein, glucose, culture, VDRL and
cryptococcal antigen.

- Psychiatric disorders on the psychotic axis, current major depression, and current
substance use disorder as assessed by the Study Enrolment Questionnaire for
Eligibility

- Severe substance use disorders (within 12 months of study entry)

- Active Hepatitis C virus (HCV) (detectable HCV RNA because HCV per se can cause
cognitive impairment)

- History of loss of consciousness >1 hour

- Non-proficient in English as assessed by the "English as a second language
questionnaire"

- Medications known pharmacologically to interact with ARVs

- Pregnancy as assessed by the urinary pregnancy test

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ViiV Healthcare
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01434654
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce J Brew, MBBS, PhD
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01434654