Effect of Cenicriviroc on HIV Neurocognitive Impairment

NCT02128828 | Completed Phase 2 Results

• 1 other identifier: H020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AIDS Dementia Complex; HIV-1-Associated Cognitive Motor Complex; Human Immunodeficiency Virus

Keywords

AIDS Dementia Complex; HIV-1-Associated Cognitive Motor Complex; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in Global Neuropsychological Performance

  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.

  baseline, week 24

Study Arms (1)

cenicriviroc

EXPERIMENTAL

cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily

Drug: cenicriviroc

Interventions

cenicriviroc DRUG

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

Also known as: TBR-652

cenicriviroc

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Active or chronic liver disease
• Active or inadequately treated tuberculosis infection, or inadequate treatment for a positive purified protein derivative test. Adequate treatment meets current recommendations of the Center for Disease Control, NIH and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA) guidelines or other Center for Disease Control recommendations if patient was treated before the current recommendations or before coinfection with HIV.
• Prior/current diagnosis with other intracellular pathogens (Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
• Uncontrolled seizures
• Current or past malignancies excluding basal cell cancer and Kaposi's sarcoma (skin).
• Immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of entry.
• Requirement for acute therapy for AIDS-defining or other serious medical illnesses within 14 days of entry.
• Other chronic illnesses including hematologic, pulmonary, autoimmune diseases and endocrinopathies, except for stable controlled diabetes or cardiovascular disease in the view of the investigator and stable testosterone or thyroid therapy.
• Known hypersensitivity to CVC or its excipients
• Anticipated need for prescription medication not allowed in the study. Unwilling to stop eating grapefruit or using St. John's wort).

Sponsors & Collaborators

• University of Hawaii: lead
• Tobira Therapeutics, Inc.: collaborator

Study Sites (1)

Clint Spencer Clinic

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

AIDS Dementia Complex; Acquired Immunodeficiency Syndrome

Interventions

cenicriviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders; Slow Virus Diseases

Results Point of Contact

• Title: Dr. Cecilia Shikuma
• Organization: University of Hawaii

shikuma@hawaii.edu

808 692-1328

Study Officials

• Cecilia Shikuma, MD

  University of Hawaii - Hawaii Center for AIDS (HICFA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept of Medicine

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: May 1, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Locations

US (1)