Effect of Cenicriviroc on HIV Neurocognitive Impairment

Human Immunodeficiency Virus Clinical Trial

Official title: H020: Single-Arm Open Label, Pilot Study of CCR5/CCR2 Inhibitor Cenicriviroc (CVC) for HIV Associated Neurocognitive Disorder (HAND)

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS Dementia Complex
• Dementia
• HIV Infections
• HIV-1-Associated Cognitive Motor Complex
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

• NCT number: NCT02128828
• Study type: Interventional
• Source: University of Hawaii
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Completion date: June 2016