Efficacy of Neuro-HAART in Patients With HIV (HANDobs)

This study has been terminated.
(Slower than expected recruitment)
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Bruce Brew, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT01434654
First received: September 12, 2011
Last updated: July 6, 2016
Last verified: July 2016
Results First Received: February 9, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from St Vincent's Hospital and/or referred from tertiary sexual health centres over the period January 2012 to June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 randomised 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 randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.

Participant Flow:   Overall Study
    Non Neuro-HAART (Low CNS Penetrance)     Neuro-HAART (High CNS Penetrance)  
STARTED     7     12  
COMPLETED     5     12  
NOT COMPLETED     2     0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data presented reflect baseline demographic and clinical characteristics for participants included in the primary analysis.

Reporting Groups
  Description
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 randomised 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 randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
Total Total of all reporting groups

Baseline Measures
    Non Neuro-HAART (Low CNS Penetrance)     Neuro-HAART (High CNS Penetrance)     Total  
Number of Participants  
[units: participants]
  5     12     17  
Age  
[units: years]
Mean (Standard Deviation)
  50.2  (7.8)     55.4  (8.6)     53.9  (8.5)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     5     12     17  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     4     11     15  
Asian     1     1     2  
Region of Enrollment  
[units: participants]
     
Australia     5     12     17  
Education  
[units: years]
Mean (Standard Deviation)
  14.4  (3.4)     12.2  (2.7)     12.8  (2.7)  
Premorbid intelligence quotient (IQ) [1]
[units: units on a scale]
Mean (Standard Deviation)
  104.2  (18.7)     102.5  (12.6)     103.0  (14.1)  
Nadir cluster of differentiation 4 (CD4)  
[units: cells/mm3]
Median (Inter-Quartile Range)
  400  
  (300.25 to 499.75)  
  115  
  (42.5 to 207.5)  
  200  
  (70 to 330)  
Current CD4  
[units: cells/mm3]
Median (Inter-Quartile Range)
  943  
  (752.5 to 1133.5)  
  583  
  (386.25 to 979.75)  
  684  
  (403.25 to 964.75)  
HIV-Associated Neurocognitive Disorder (HAND) status  
[units: participants]
     
Normal/Unimpaired     1     2     3  
Asymptomatic Neurocognitive Impairment (ANI)     2     7     9  
Mild Neurocognitive Disorder (MND)     1     3     4  
HIV-Associated Dementia (HAD)     1     0     1  
[1] Full-scale IQ based on National Adult Reading Test (NART) error score. NART is a test of reading ability that has been extensively validated for use as a proxy measure of pre-morbid intellectual functioning. Full-Scale IQ score is expressed as a Standard Score with Mean=100 and Standard Deviation=15. Possible values range from 69-131. Higher scores indicate better performance.



  Outcome Measures
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1.  Primary:   Change in Neurocognitive Functioning   [ Time Frame: Change from baseline Neuropsychological testing at 6 and 12 months ]

2.  Secondary:   Change in MRS Cerebral Metabolite Ratios in Basal Ganglia   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Change in MRS Cerebral Metabolite Ratios in Frontal White Matter   [ Time Frame: Baseline and 12 months ]

4.  Secondary:   Cerebrospinal Fluid   [ Time Frame: Baseline to 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lower than expected participant recruitment rate and early termination led to a small sample size and underpowered statistical analyses


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Bruce Brew
Organization: St Vincent's Hospital, Sydney
phone: +61 2 8382 1111 ext 4100
e-mail: b.brew@unsw.edu.au



Responsible Party: Bruce Brew, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT01434654     History of Changes
Other Study ID Numbers: 09/192
COL114560 ( Other Grant/Funding Number: VIIV Healthcare )
Study First Received: September 12, 2011
Results First Received: February 9, 2016
Last Updated: July 6, 2016
Health Authority: Australia: Human Research Ethics Committee