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| Name | Class |
|---|---|
| Tobira Therapeutics, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cenicriviroc | Experimental | cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Shikuma, MD | University of Hawaii - Hawaii Center for AIDS (HICFA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clint Spencer Clinic | Honolulu | Hawaii | 96813 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cenicriviroc | cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily cenicriviroc: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cenicriviroc | cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily cenicriviroc: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | baseline, week 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cenicriviroc | cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily cenicriviroc: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cecilia Shikuma | University of Hawaii | 808 692-1328 | shikuma@hawaii.edu |
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| ID | Term |
|---|---|
| D015526 | AIDS Dementia Complex |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C506967 | cenicriviroc |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| Loose stools | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012897 | Slow Virus Diseases |