Effect of Cenicriviroc on HIV Neurocognitive Impairment
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|ClinicalTrials.gov Identifier: NCT02128828|
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|AIDS Dementia Complex HIV-1-Associated Cognitive Motor Complex Human Immunodeficiency Virus||Drug: cenicriviroc||Phase 2|
HIV-associated neurocognitive disease (HAND), particularly in its milder form, is estimated to occur in greater than 30% of HIV infected individuals in the era of potent antiretroviral therapy. As even mild disease leads to functional consequences with decreased ability to live independently, HAND is of substantial public health concern. HIV-induced immune activation/inflammation of monocytes (MO) may be primarily responsible for the development of HAND.
Cenicriviroc is a combined CCR5 and CCR2 chemokine co-receptor antagonist. The investigators hypothesize that dual CCR5 and CCR2 blockade with the use of CVC will lead to measurable reductions in MO activation and lead to cognitive improvement by decreasing HIV infection of MO and by interrupting the trafficking of such MO into the central nervous system.
The investigators propose a single arm, 24-week trial of CVC in 24 subjects with HIV-1 infection suppressed on ART (plasma HIV RNA < 50 copies/ml) for 1 year or more with mild to moderate cognitive impairment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||H020: Single-Arm Open Label, Pilot Study of CCR5/CCR2 Inhibitor Cenicriviroc (CVC) for HIV Associated Neurocognitive Disorder (HAND)|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily
cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc
Other Name: TBR-652
- Change From Baseline to Week 24 in Global Neuropsychological Performance [ Time Frame: baseline, week 24 ]Raw scores from individual performance on 14 validated neuropsychological tests meant to assess various cognitive domains were converted into standardized z-scores adjusted for age, sex, and education. Z-scores from all tests were aggregated and averaged to determine each subject's Global Neuropsychological Performance Score; NPZ-Global). Z-scores follow a normal distribution with scores < '0' identifying poorer cognition than 'average' and scores > "0" identifying better cognition than average with -1 and +1 represented 1 SD below or higher than average.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128828
|United States, Hawaii|
|Clint Spencer Clinic|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Cecilia Shikuma, MD||University of Hawaii - Hawaii Center for AIDS (HICFA)|