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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by St Vincent's Hospital, Sydney
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: October 7, 2012
Last verified: October 2012

October 6, 2011
October 7, 2012
October 2011
Not Provided
Change in neurocognitive Function [ Time Frame: Change from baseline neuropsychological exam, to 6 and 12 month exam ] [ Designated as safety issue: No ]
To compare the overall neuropsychological performance, defined as a reliable change score index (RCI).
Same as current
Complete list of historical versions of study NCT01449006 on ClinicalTrials.gov Archive Site
Change in CSF Neopterin Concentration [ Time Frame: Change in CSF neopterin concentration from baseline to 12 months ] [ Designated as safety issue: No ]
To determine if there is improvement in CSF neopterin concentrations with the addition of Maraviroc.
Same as current
Not Provided
Not Provided
 
A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac)
A Randomised Controlled Clinical Trial of the Efficacy of HAART Intensification With Maraviroc in HIV Virally Suppressed Patients With Cognitive Impairment

HIV related cognitive impairment still occurs despite highly active antiretroviral therapy (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease; leading to varying degrees of cognitive impairment, recently termed HIV associated neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in both blood and CSF.

Patients with HIV Associated Neurocognitive Disorders (HAND) who are virally suppressed in both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART) regimen may have significant cognitive improvement with HAART intensification with the medication Maraviroc; compared to those who remain on their existing regimen.

This study will be a prospective, interventional, randomised and unblinded controlled clinical trial. The aim of this study will be to determine whether HAART intensification with the medication Maraviroc, leads to significant improvement in HIV associated neurocognitive disorders (HAND).

Patients with the recent progression (within 6 months) of HAND (validated by neuropsychological assessment) on HAART, who are virally suppressed (<50 copies per ml) in blood and CSF will be randomised to have their existing HAART regimen intensified with Maraviroc, or not. The control arm will remain on their medication regimen as prescribed. The target is to enrol 70 patients into the control group, and 70 patients into the Maraviroc intensification group.

Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebrospinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the effectiveness of adding Maraviroc, will include further neuropsychological assessment at 6 months, and neuropsychological assessment, and CSF assessment again at 12 months.

Neuropsychological testing completed at 6 and 12 months will be completed by a "blind assessor", in that they will have no knowledge of which arm (treatment or control) the participant is enrolled in.

An evaluation (neuropsychological testing) will be performed should the patient deteriorate during the course of the study, as recognised by the patient's managing physician.

At the end of the study protocol (12 months) the patient's HAART therapy will be managed by their primary physician.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Human Immunodeficiency Virus (HIV)
  • HIV Associated Neurocognitive Disorders (HAND)
Drug: 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.
Other Names:
  • Maraviroc
  • Celsentri
  • No Intervention: Standard of care HAART regimen
    Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
  • Experimental: 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.
    Intervention: Drug: Maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
140
Not Provided
Not Provided

Inclusion Criteria:

  • HIV Positive
  • On HAART, with plasma viral load < 50 copies/ml for previous 12 months or more
  • Able to provide informed consent
  • HAND diagnosis, with symptom progression within previous 6 months

Exclusion Criteria:

  • Non-HIV related neurological disorders and active CNS opportunistic infection (as assessed by full blood count, electrolytes, creatinine, glucose, LFT's, cryptococcal antigen, VDRL, MRI brain scan and CSF analysis for cell count, protein, glucose, culture, VDRL and cryptococcal antigen)
  • Psychiatric disorders on the psychiatric axis
  • Current major depression
  • Current substance use disorder, or severe substance use disorder within 12 months of study entry
  • Active HCV (detectable HCV RNA)
  • History of loss of consciousness > 1 hour
  • Non-proficient in English
  • Medications known to pharmacologically interact with ARV's
  • Currently taking an entry inhibitor
  • Pregnancy (as assessed by the urine pregnancy test)
Both
18 Years and older
No
Contact: Bruce J Brew, MBBS, PhD 61 2 8382 1111 ext 4100 bbrew@stvincents.com.au
Contact: Krista J Siefried, RN 61 2 8382 1111 ext 2668 ksiefried@stvincents.com.au
Australia
 
NCT01449006
11/066, 114560
Yes
Bruce Brew, St Vincent's Hospital
Bruce Brew
ViiV Healthcare
Not Provided
St Vincent's Hospital, Sydney
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP