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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Week 24 in Global Neuropsychological Performance