Trial Outcomes & Findings for An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects (NCT NCT00802074)
NCT ID: NCT00802074
Last Updated: 2016-01-29
Results Overview
Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). 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
45 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 Period2- 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
|
9
|
8
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
6
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
0
|
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 Period2- 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
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Group A
n=7 Participants
Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group B
n=7 Participants
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group C
n=6 Participants
Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group E
n=7 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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group F
n=7 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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18-25
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
20 participants
n=8 Participants
|
|
Age, Customized
26-33
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
Age, Customized
34-41
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Age, Customized
42-49
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Age, Customized
50 and older
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
7 participants
n=8 Participants
|
41 participants
n=8 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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). 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.
Outcome measures
| Measure |
Group A & B
n=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
Cmin/Cmax: Fasting 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)
|
0.57 ng/mL
Interval 0.43 to 0.76
|
0.81 ng/mL
Interval 0.58 to 1.13
|
0.50 ng/mL
Interval 0.34 to 0.74
|
—
|
—
|
—
|
|
Cmin/Cmax: Fasting 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)
|
0.73 ng/mL
Interval 0.53 to 1.01
|
0.86 ng/mL
Interval 0.64 to 1.15
|
0.82 ng/mL
Interval 0.67 to 0.99
|
—
|
—
|
—
|
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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). 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.
Outcome measures
| Measure |
Group A & B
n=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
AUC: Fasting 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.
|
0.64 ng•h/mL
Interval 0.47 to 0.88
|
0.84 ng•h/mL
Interval 0.64 to 1.08
|
0.76 ng•h/mL
Interval 0.59 to 0.97
|
—
|
—
|
—
|
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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). 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.
Outcome measures
| Measure |
Group A & B
n=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
CL/F: Fasting 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.
|
1.57 L/h
Interval 1.14 to 2.16
|
1.05 L/h
Interval 0.74 to 1.5
|
1.63 L/h
Interval 1.22 to 2.18
|
—
|
—
|
—
|
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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL 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=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
Cmin (ng/mL)
|
0.62 ng/mL
Interval 0.43 to 0.89
|
0.64 ng/mL
Interval 0.43 to 0.97
|
0.75 ng/mL
Interval 0.59 to 0.96
|
—
|
—
|
—
|
|
Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
Cmax (ng/mL)
|
0.72 ng/mL
Interval 0.41 to 1.26
|
0.49 ng/mL
Interval 0.25 to 0.97
|
1.06 ng/mL
Interval 0.62 to 1.81
|
—
|
—
|
—
|
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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL 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=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
|
0.63 ng*h/mL
Interval 0.4 to 0.99
|
0.45 ng*h/mL
Interval 0.24 to 0.84
|
0.85 ng*h/mL
Interval 0.54 to 1.33
|
—
|
—
|
—
|
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 regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL 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=14 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=13 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=14 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
|
1.46 L/h
Interval 0.92 to 2.2
|
2.00 L/h
Interval 1.1 to 3.62
|
1.18 L/h
Interval 0.77 to 1.79
|
—
|
—
|
—
|
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 AE's for each sequence and not for each regimen. 3The 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=7 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=7 Participants
Group C Period 1-Raltegravir 400mg BID Period2- 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=6 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 + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group E
n=7 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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
Group F
n=7 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
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Adverse Events
|
3 participants
|
3 participants
|
4 participants
|
4 participants
|
5 participants
|
5 participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 4 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: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=7 participants at risk
Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
|
Group B
n=7 participants at risk
Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
|
Group C
n=6 participants at risk
Period 1-Raltegravir 400mg BID Period2- 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 + Ritonavir 100mg BID
|
Group E
n=7 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=7 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
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting/Diarrhea
|
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.
|
42.9%
3/7 • 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.
|
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.
|
57.1%
4/7 • 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.
|
57.1%
4/7 • 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.
|
57.1%
4/7 • 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.
|
|
General disorders
fatigue
|
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.
|
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.
|
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.
|
|
General disorders
numbness of lips/tongue/mouth
|
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.
|
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.
|
42.9%
3/7 • 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.
|
|
Nervous system disorders
headache/migraine
|
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.
|
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.
|
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.
|
|
General disorders
cold symptoms/uri/fever
|
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.
|
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.
|
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.
|
|
Gastrointestinal disorders
Itching
|
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.
|
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.
|
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.
|
|
General disorders
frequent urination
|
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%
0/7 • 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%
0/7 • 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.
|
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