Trial Outcomes & Findings for Sustiva Levels With Use of a Gel Capsule (NCT NCT01087814)
NCT ID: NCT01087814
Last Updated: 2017-03-09
Results Overview
Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
5th day of taking drug
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
Efavirenz First, Then Over-encapsulated Efavirenz
This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
|
Over-encapsulated Efavirenz First, Then Efavirenz
This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
|
|---|---|---|
|
First Intervention (5 Days)
STARTED
|
8
|
7
|
|
First Intervention (5 Days)
COMPLETED
|
5
|
6
|
|
First Intervention (5 Days)
NOT COMPLETED
|
3
|
1
|
|
Second Intervention (5 Days)
STARTED
|
5
|
6
|
|
Second Intervention (5 Days)
COMPLETED
|
4
|
6
|
|
Second Intervention (5 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Efavirenz First, Then Over-encapsulated Efavirenz
This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
|
Over-encapsulated Efavirenz First, Then Efavirenz
This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
|
|---|---|---|
|
First Intervention (5 Days)
Withdrawal by Subject
|
3
|
1
|
|
Second Intervention (5 Days)
Physician Decision
|
1
|
0
|
Baseline Characteristics
Sustiva Levels With Use of a Gel Capsule
Baseline characteristics by cohort
| Measure |
Efavirenz
n=8 Participants
Both arms received both versions of the drug during the course of the study.
|
Over-encapsulated Efavirenz
n=7 Participants
Both arms received both versions of the drug over the course of the study.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.125 years
STANDARD_DEVIATION 8.45893 • n=5 Participants
|
25.875 years
STANDARD_DEVIATION 2.53194 • n=7 Participants
|
26 years
STANDARD_DEVIATION 6.03324 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5th day of taking drugSerum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
Outcome measures
| Measure |
Efavirenz (Tablet)
n=10 Participants
All subjects took efavirenz.
|
Over-encapsulated Efavirenz
n=10 Participants
All subjects took over-encapsulated efavirenz.
|
|---|---|---|
|
Serum Levels of Efavirenz
|
5151.11 ng/mL
Standard Deviation 765.67
|
4965.08 ng/mL
Standard Deviation 1285.48
|
Adverse Events
Efavirenz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Over-encapsulated Efavirenz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place