Status:
TERMINATED
Efficacy of Neuro-HAART in Patients With HIV
Lead Sponsor:
St Vincent's Hospital, Sydney
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV
Eligibility:
All Genders
18+ years
Brief Summary
Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related complications despite the use of highly active antiretroviral therapy (HAART). Such complications are termed HIV ...
Eligibility Criteria
Inclusion
- HIV positive with nadir cluster of differentiation 4 (CD4) count \<350 /microlitre (uL)
- Taking HAART with CNS Penetration Effectiveness (CPE) score of either ≤7.0 or ≥7.5 for 1 year or more. Changes in antiretrovirals (ARVs) within the last 12 months are allowed so long as the CPE score does not lead to a change groups
- Plasma HIV viral load \<50 copies / mL for preceding 12 months or longer
- Informed consent given by participant or legally appointed guardian
Exclusion
- Non-HIV related neurological disorders and active CNS opportunistic infection as assessed by full blood count, electrolytes, creatinine, glucose, liver function tests, cryptococcal antigen, venereal disease reaction level (VDRL), MRI brain scan and cerebrospinal fluid analyses for cell count, protein, glucose, culture, VDRL and cryptococcal antigen.
- Psychiatric disorders on the psychotic axis, current major depression, and current substance use disorder as assessed by the Study Enrolment Questionnaire for Eligibility
- Severe substance use disorders (within 12 months of study entry)
- Active Hepatitis C virus (HCV) (detectable HCV RNA because HCV per se can cause cognitive impairment)
- History of loss of consciousness \>1 hour
- Non-proficient in English as assessed by the "English as a second language questionnaire"
- Medications known pharmacologically to interact with ARVs
- Pregnancy as assessed by the urinary pregnancy test
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01434654
Start Date
September 1 2011
End Date
September 1 2014
Last Update
August 9 2016
Active Locations (2)
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1
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
2
The Alfred Hospital
Prahran, Victoria, Australia, 3181