Trial Outcomes & Findings for An Interaction Study to Assess Drug Levels in Healthy Adult Subjects (NCT NCT00614991)
NCT ID: NCT00614991
Last Updated: 2016-01-29
Results Overview
APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens
Results posted on
2016-01-29
Participant Flow
Participant milestones
| Measure |
Group A
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
|
Group B
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
7
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
|
Group B
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Group A
n=5 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
|
Group B
n=6 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
n=7 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
|
Group D
n=7 Participants
Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
n=6 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
n=6 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Total
n=37 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
37 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimensAPV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
Cmin (ng/mL)
|
0.67 ng/mL
Interval 0.49 to 0.93
|
0.67 ng/mL
Interval 0.5 to 0.9
|
0.83 ng/mL
Interval 0.57 to 1.23
|
—
|
—
|
—
|
|
Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
Cmax (ng/mL)
|
0.83 ng/mL
Interval 0.71 to 0.98
|
0.75 ng/mL
Interval 0.59 to 0.96
|
1.27 ng/mL
Interval 1.02 to 1.58
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimensAPV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
|
0.81 ng•h/mL
Interval 0.71 to 0.93
|
0.75 ng•h/mL
Interval 0.58 to 0.97
|
1.13 ng•h/mL
Interval 0.95 to 1.35
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimensAPV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
|
1.26 L/H
Interval 1.08 to 1.46
|
1.43 L/H
Interval 1.08 to 1.89
|
1.05 L/H
Interval 0.8 to 1.38
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimensRAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.
Cmin (ng/mL)
|
0.32 ng/mL
Interval 0.15 to 0.66
|
0.46 ng/mL
Interval 0.26 to 0.82
|
0.59 ng/mL
Interval 0.27 to 1.3
|
—
|
—
|
—
|
|
Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.
Cmax (ng/mL)
|
0.95 ng/mL
Interval 0.64 to 1.43
|
0.44 ng/mL
Interval 0.3 to 0.66
|
0.85 ng/mL
Interval 0.58 to 1.24
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimensAPV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
|
0.71 ng•h/mL
Interval 0.54 to 0.94
|
0.46 ng•h/mL
Interval 0.34 to 0.63
|
0.70 ng•h/mL
Interval 0.52 to 0.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimensAPV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F
Outcome measures
| Measure |
Group A & B
n=11 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=14 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=12 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
|
1.02 L/h
Interval 0.88 to 1.19
|
2.30 L/h
Interval 1.52 to 3.47
|
1.46 L/h
Interval 0.96 to 2.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 through Day 49Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were: * RAL 400mg BID alone * FPV 1400mg BID alone * FPV 700mg/RTV 100 mg BID alone * FPV 1400mg/RTV 100mg QD alone * FPV 1400mg BID combined with RAL 400mg BID * FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID * FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004.
Outcome measures
| Measure |
Group A & B
n=5 Participants
Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=6 Participants
Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=7 Participants
Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
n=7 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
n=6 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
n=6 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Adverse Events
|
0 participants
|
4 participants
|
6 participants
|
5 participants
|
5 participants
|
4 participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group E
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group F
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=5 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
|
Group B
n=6 participants at risk
Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
n=7 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
|
Group D
n=7 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
|
Group E
n=6 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
|
Group F
n=6 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
33.3%
2/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
28.6%
2/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Headache
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
28.6%
2/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Dizzy
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Dry mouth/loss of appetite
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Sinus infection/Flu like symptoms
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
28.6%
2/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Numbness of mouth/lips/tongue
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Increased urination
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
14.3%
1/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Nausea/Vomiting/Diarrhea
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
50.0%
3/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
71.4%
5/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
71.4%
5/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
50.0%
3/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
50.0%
3/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Sleep disturbance
|
0.00%
0/5 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/7 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.7%
1/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/6 • Reported Adverse Events (AE) included events starting on or after Day 0 through Day 49.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
Additional Information
David Condoluci
Garden State Infectious Disease Associates
Phone: 856-566-3190
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place