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
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
HIV Associated Neurocognitive Disorders (HAND)
Drug: Maraviroc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Clinical Trial of the Efficacy of HAART Intensification With Maraviroc in HIV Virally Suppressed Patients With Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 140
Study Start Date: October 2011
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449006

Contacts
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

Locations
Australia, New South Wales
St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Australia, Victoria
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bruce Brew
ViiV Healthcare
  More Information

No publications provided

Responsible Party: Bruce Brew, Professor, St Vincent's Hospital
ClinicalTrials.gov Identifier: NCT01449006     History of Changes
Other Study ID Numbers: 11/066, 114560
Study First Received: October 6, 2011
Last Updated: October 7, 2012
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by St Vincent's Hospital, Sydney:
HIV
HAND
Maraviroc
Neurocognitive
Neurology
Human Immunodeficiency Virus
HIV Associated Neurocognitive Disorders

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014