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A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) (HANDmac)

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Bruce Brew, St Vincent's Hospital
ClinicalTrials.gov Identifier:
NCT01449006
First received: October 6, 2011
Last updated: April 13, 2016
Last verified: April 2016
Results First Received: February 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Human Immunodeficiency Virus (HIV)
HIV Associated Neurocognitive Disorders (HAND)
Intervention: Drug: Maraviroc

  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
Two enrolled participants failed screening (1 HCV+, 1 not cognitively impaired)

Reporting Groups
  Description
Standard of Care HAART Regimen Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
Maraviroc

Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.

Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet.


Participant Flow:   Overall Study
    Standard of Care HAART Regimen     Maraviroc  
STARTED     8     9  
COMPLETED     5     9  
NOT COMPLETED     3     0  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 0  
Protocol Violation                 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
Standard of Care HAART Regimen Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
Maraviroc

Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.

Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet.

Total Total of all reporting groups

Baseline Measures
    Standard of Care HAART Regimen     Maraviroc     Total  
Number of Participants  
[units: participants]
  5     9     14  
Age  
[units: years]
Mean (Standard Deviation)
  60  (9.4)     52.2  (3.7)     55  (7.1)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     5     9     14  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     5     9     14  
Region of Enrollment  
[units: participants]
     
Australia     5     9     14  
Education  
[units: years]
Mean (Standard Deviation)
  11.6  (2.3)     12.3  (2.8)     12.1  (2.6)  
Premorbid intelligence quotient (IQ) [1]
[units: units on a scale]
Mean (Standard Deviation)
  104.4  (18.9)     102.2  (16.3)     103  (16.6)  
Nadir cluster of differentiation 4 (CD4)  
[units: cells/mm3]
Median (Inter-Quartile Range)
  310  
  (51 to 390)  
  150  
  (33.5 to 253.5)  
  174.5  
  (36.8 to 312.5)  
Current CD4  
[units: cells/mm3]
Median (Inter-Quartile Range)
  980  
  (548 to 1041)  
  499  
  (338 to 827.5)  
  625.5  
  (400.8 to 979.3)  
HAND Status  
[units: participants]
     
Asymptomatic Neurocognitive Impairment (ANI)     1     1     2  
Mild Neurocognitive Disorder (MND)     2     8     10  
HIV-Associated Dementia (HAD)     2     0     2  
[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. Values range from 69-131. Higher scores indicate better performance.



  Outcome Measures
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1.  Primary:   Change in Neurocognitive Functioning   [ Time Frame: Baseline, 6-months and 12-months ]

2.  Secondary:   Change in CSF Neopterin Concentration   [ Time Frame: Baseline and 12-months ]

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

4.  Secondary:   Change in MRS Cerebral Metabolite Ratios in Frontal White Matter   [ Time Frame: Baseline and 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
  1. Small pilot sample size (N=17).
  2. Unrepresentative of international HAND populations.
  3. Open-label design may have contributed to loss to follow-up in controls.
  4. Modified intention-to-treat design potentially introduced bias into analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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, Australia
phone: 61 2 8382 1111 ext 4100
e-mail: bruce.brew@svha.org.au


Publications of Results:

Responsible Party: Bruce Brew, St Vincent's Hospital
ClinicalTrials.gov Identifier: NCT01449006     History of Changes
Other Study ID Numbers: 11/066
114560 ( Other Grant/Funding Number: VIIV Healthcare Australia )
Study First Received: October 6, 2011
Results First Received: February 9, 2016
Last Updated: April 13, 2016
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration