Trial Outcomes & Findings for Effect of Cenicriviroc on HIV Neurocognitive Impairment (NCT NCT02128828)
NCT ID: NCT02128828
Last Updated: 2020-08-20
Results Overview
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.
COMPLETED
PHASE2
20 participants
baseline, week 24
2020-08-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Cenicriviroc on HIV Neurocognitive Impairment
Baseline characteristics by cohort
| Measure |
Cenicriviroc
n=17 Participants
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
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 24Raw 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.
Outcome measures
| Measure |
Cenicriviroc
n=17 Participants
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
|
|---|---|
|
Change From Baseline to Week 24 in Global Neuropsychological Performance
|
.24 units on a scale
Interval -0.03 to 0.46
|
Adverse Events
Cenicriviroc
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cenicriviroc
n=20 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20
|
|
Gastrointestinal disorders
Loose stools
|
10.0%
2/20
|
|
General disorders
Fatigue
|
20.0%
4/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place