Effect of Cenicriviroc on HIV Neurocognitive Impairment (NCT02128828) | Clinical Trial Compass
CompletedPhase 2
Effect of Cenicriviroc on HIV Neurocognitive Impairment
United States20 participantsStarted 2014-04
Plain-language summary
The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals with cognitive impairment. The investigators will study the effect of cenicriviroc on cognition in 24 subjects over a 24 week period.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 4.2.1.1 Documentation of HIV-1 infection by an FDA approved test at any time prior to study entry
* On ARV medication uninterrupted for \> 1 year leading up to the screening period
* Screening plasma HIV RNA \< 50 copies/ml within 3 months of entry
* Willingness for males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.
* Age 18 to 70 years
* Ability and willingness to provide written informed consent
* Mild to moderate cognitive impairment with global neuropsychological (NP) test (NPZglobal) score of \< -0.5 or a neurocognitive abnormality (\<-0.5) in at least one cognitive domain known to be typically affected by HIV OR unimpaired
* On antiretroviral (ARV) therapy consisting of nucleoside reverse transcriptase inhibitors, atazanavir with/or without ritonavir, darunavir plus ritonavir, dolutegravir, raltegravir or efavirenz.
Exclusion Criteria:
* Receiving or used a CCR5 antagonist within 6 months of study entry
* Plasma HIV RNA \> 100 copies/ml within 6 mo. of screening
* HIV-2
* Chronic hepatitis B (positive hepatitis B surface antigen)
* Chronic hepatitis C (positive hepatitis C antibody), except with proof of viral clearance and normal liver function tests
…
What they're measuring
1
Change From Baseline to Week 24 in Global Neuropsychological Performance