Trial Outcomes & Findings for Pharmacokinetics of JULUCA in Hemodialysis (NCT NCT04431518)
NCT ID: NCT04431518
Last Updated: 2024-06-05
Results Overview
Steady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
0 to 24 hours post-dose on the intensive study visit
Results posted on
2024-06-05
Participant Flow
Participant milestones
| Measure |
Hemodialysis Group
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of JULUCA in Hemodialysis
Baseline characteristics by cohort
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=99 Participants
|
57.25 years
n=107 Participants
|
57.375 years
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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 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
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 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
|
PRIMARY outcome
Timeframe: 0 to 24 hours post-dose on the intensive study visitSteady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Outcome measures
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
Dolutegravir (DTG) Ctau
|
1259 ng/mL
Standard Deviation 447
|
1666 ng/mL
Standard Deviation 415
|
PRIMARY outcome
Timeframe: 0 to 24 hours post-dose on the intensive study visitSteady-state plasma Ctau for rilpivirine at the intensive study visit, which occurred between days 11 and 14
Outcome measures
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
Rilpivirine (RPV) Ctau
|
50 ng/mL
Standard Deviation 17
|
77 ng/mL
Standard Deviation 47
|
SECONDARY outcome
Timeframe: 30 daysThe attributable grade 3 or 4 adverse events associated with use of DTG will be assessed during the study. Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Grade 3 indicates a severe event, and Grade 4 indicates a potentially life-threatening event.
Outcome measures
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
Safety of DTG
|
0 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on the intensive study visitSteady-state plasma AUC for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Outcome measures
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
DTG AUC
|
78095 h*ng/mL
Standard Deviation 28979
|
75301 h*ng/mL
Standard Deviation 23090
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on the intensive study visitSteady-state plasma Cmax for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Outcome measures
| Measure |
Hemodialysis Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 Participants
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
DTG Cmax
|
6346 ng/mL
Standard Deviation 2593
|
5984 ng/mL
Standard Deviation 2804
|
Adverse Events
Hemodialysis Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Normal Renal Function Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hemodialysis Group
n=4 participants at risk
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
Normal Renal Function Group
n=4 participants at risk
Receipt of JULUCA one pill per day up to 14 days
JULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
25.0%
1/4 • Number of events 1 • 30 days
|
0.00%
0/4 • 30 days
|
|
Nervous system disorders
headache
|
25.0%
1/4 • Number of events 1 • 30 days
|
0.00%
0/4 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pain
|
25.0%
1/4 • Number of events 1 • 30 days
|
25.0%
1/4 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place