Trial Outcomes & Findings for Maraviroc Efficacy for Hepatitis C (NCT NCT02881762)
NCT ID: NCT02881762
Last Updated: 2024-05-01
Results Overview
Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2024-05-01
Participant Flow
Participants enrolled at the clinical research unit at the University of Maryland, Baltimore between June 2017 to April 2018
Participant milestones
| Measure |
Maraviroc First, Then No Maraviroc
Participants first received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. After a washout period of 4 weeks, they then received no maraviroc for 4 weeks.
|
No Maraviroc First, Then Maraviroc
Participants first received no maraviroc for 4 weeks. After a washout period of 4 weeks, they then received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. Participants are then seen for their last visit 4 weeks after their last dose of maraviroc.
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
5
|
5
|
|
First Intervention (4 Weeks)
COMPLETED
|
5
|
4
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (4 Weeks)
STARTED
|
5
|
4
|
|
Washout (4 Weeks)
COMPLETED
|
5
|
4
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
5
|
4
|
|
Second Intervention (4 Weeks)
COMPLETED
|
5
|
4
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Followup No Maraviroc First Only (4 Wks)
STARTED
|
5
|
4
|
|
Followup No Maraviroc First Only (4 Wks)
COMPLETED
|
5
|
4
|
|
Followup No Maraviroc First Only (4 Wks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Maraviroc First, Then No Maraviroc
Participants first received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. After a washout period of 4 weeks, they then received no maraviroc for 4 weeks.
|
No Maraviroc First, Then Maraviroc
Participants first received no maraviroc for 4 weeks. After a washout period of 4 weeks, they then received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. Participants are then seen for their last visit 4 weeks after their last dose of maraviroc.
|
|---|---|---|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Maraviroc Efficacy for Hepatitis C
Baseline characteristics by cohort
| Measure |
Maraviroc First, Then no Maraviroc
n=5 Participants
Participants first received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. After a washout period of 4 weeks, they then received no maraviroc for 4 weeks.
|
No Maraviroc First, Then Maraviroc
n=4 Participants
Participants first received no maraviroc for 4 weeks. After a washout period of 4 weeks, they then received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. Participants are then seen for their last visit 4 weeks after their last dose of maraviroc.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 3.1 • n=99 Participants
|
55.8 Years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
56.2 Years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Hepatitis C viral load
|
1734274 International Units/ml
STANDARD_DEVIATION 949012 • n=99 Participants
|
2411068 International Units/ml
STANDARD_DEVIATION 1093469 • n=107 Participants
|
2035071 International Units/ml
STANDARD_DEVIATION 1012880 • n=206 Participants
|
|
Alanine transaminase
|
39.6 International Units/ml
STANDARD_DEVIATION 21.2 • n=99 Participants
|
31.8 International Units/ml
STANDARD_DEVIATION 2.6 • n=107 Participants
|
36.1 International Units/ml
STANDARD_DEVIATION 15.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the final analysis
Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.
Outcome measures
| Measure |
Maraviroc
n=9 Participants
Participants who received Maraviroc daily either in the first 4 weeks or during week 8 to week 12
|
No Maraviroc
n=9 Participants
Participants who received No Maraviroc daily either the first 4 weeks or during weeks 8 to 12 of the study.
|
|---|---|---|
|
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
HCV viral load at baseline
|
2035071 International Units/ml
Standard Deviation 1012880
|
2027648 International Units/ml
Standard Deviation 1411027
|
|
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
HCV viral load at 4 weeks
|
2082302 International Units/ml
Standard Deviation 1673228
|
1216383 International Units/ml
Standard Deviation 769289.8
|
|
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
Change in HCV viral load at 4 weeks
|
47231 International Units/ml
Standard Deviation 805651.4
|
-811264 International Units/ml
Standard Deviation 1357476
|
SECONDARY outcome
Timeframe: 7 daysHCV viral load was measured before starting and at 7 days of maraviroc. Among participants that received Maraviroc in the first 4 weeks, HCV viral load was measured before first dose at day 0 and at day 7. Among participants that received Maraviroc in week 8 to 12, HCV viral load measured at day 56 before taking the first dose of Maraviroc and at day 63 (week 9) of study.
Outcome measures
| Measure |
Maraviroc
n=9 Participants
Participants who received Maraviroc daily either in the first 4 weeks or during week 8 to week 12
|
No Maraviroc
n=9 Participants
Participants who received No Maraviroc daily either the first 4 weeks or during weeks 8 to 12 of the study.
|
|---|---|---|
|
Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc
|
2035071 International Units/ml
Standard Deviation 1012880
|
2138768 International Units/ml
Standard Deviation 1732285
|
Adverse Events
Maraviroc
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
No Maraviroc
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc
n=9 participants at risk
Participants who received Maraviroc daily either in the first 4 weeks or during week 8 to week 12
|
No Maraviroc
n=9 participants at risk
Participants who received No Maraviroc daily either the first 4 weeks or during weeks 8 to 12 of the study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tibial plateau fracture
|
11.1%
1/9 • Number of events 1 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
0.00%
0/9 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
Other adverse events
| Measure |
Maraviroc
n=9 participants at risk
Participants who received Maraviroc daily either in the first 4 weeks or during week 8 to week 12
|
No Maraviroc
n=9 participants at risk
Participants who received No Maraviroc daily either the first 4 weeks or during weeks 8 to 12 of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
0.00%
0/9 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • Number of events 1 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
0.00%
0/9 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
|
Musculoskeletal and connective tissue disorders
Soft tissue injury
|
11.1%
1/9 • Number of events 1 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
0.00%
0/9 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
|
Skin and subcutaneous tissue disorders
Bruise
|
0.00%
0/9 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
11.1%
1/9 • Number of events 1 • Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place