Status:
COMPLETED
A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac)
Lead Sponsor:
Bruce Brew
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Human Immunodeficiency Virus (HIV)
HIV Associated Neurocognitive Disorders (HAND)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
- Non-HIV related neurological disorders and active central nervous system (CNS) opportunistic infection (as assessed by full blood count, electrolytes, creatinine, glucose, liver funciton tests, cryptococcal antigen, venereal disease research laboratory (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 Hepatitis C Virus (HCV) (detectable HCV RNA)
- History of loss of consciousness \> 1 hour
- Non-proficient in English
- Medications known to pharmacologically interact with antiretrovirals (ARVs)
- Currently taking an entry inhibitor
- Pregnancy (as assessed by the urine pregnancy test)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01449006
Start Date
October 1 2011
End Date
September 1 2014
Last Update
February 27 2019
Active Locations (2)
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1
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
2
The Alfred Hospital
Melbourne, Victoria, Australia, 3181