Status:
TERMINATED
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV
Lead Sponsor:
St Vincent's Hospital, Sydney
Collaborating Sponsors:
Merck Sharp & Dohme LLC
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 de...
Eligibility Criteria
Inclusion
- HIV positive
- On HAART, with plasma HIV 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 (while on existing HAART regimen)
Exclusion
- 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 fluid analysis for cell count, protein, glucose, culture, VDRL and cryptococcal antigen)
- Psychiatric disorders on the psychotic axis
- Current major depression
- Current substance use disorder, or severe substance use disorders 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 Integrase Inhibitor
- Pregnancy (as assessed by the urine pregnancy test)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01448486
Start Date
October 1 2011
End Date
October 1 2013
Last Update
June 27 2016
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