Trial Outcomes & Findings for An Interaction Study to Assess Drug Levels in Healthy Adult Subjects (NCT NCT00764465)
NCT ID: NCT00764465
Last Updated: 2016-01-29
Results Overview
Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens
Results posted on
2016-01-29
Participant Flow
Participant milestones
| Measure |
Group A
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
|
Group B
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
7
|
7
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group A
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
|
Group B
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Group A
n=7 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
|
Group B
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
|
Group D
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
n=7 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
7 Participants
n=19 Participants
|
38 Participants
n=147 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
20 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
18 Participants
n=147 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=39 Participants
|
6 participants
n=41 Participants
|
6 participants
n=35 Participants
|
6 participants
n=31 Participants
|
6 participants
n=146 Participants
|
7 participants
n=19 Participants
|
38 participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).
Outcome measures
| Measure |
Group A & B
n=13 Participants
Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=12 Participants
Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=13 Participants
Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg 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 (Maraviroc) MVC 300mg BID.
Cmin
|
0.99 ng/mL
Interval 0.74 to 1.34
|
0.76 ng/mL
Interval 0.57 to 1.01
|
0.68 ng/mL
Interval 0.5 to 0.92
|
—
|
—
|
—
|
|
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 (Maraviroc) MVC 300mg BID.
Cmax
|
0.49 ng/mL
Interval 0.31 to 0.77
|
0.69 ng/mL
Interval 0.59 to 0.81
|
0.68 ng/mL
Interval 0.61 to 0.77
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimensAmprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).
Outcome measures
| Measure |
Group A & B
n=13 Participants
Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=12 Participants
Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=13 Participants
Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg 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 (Maraviroc) MVC 300mg BID.
|
0.56 ng•h/mL
Interval 0.36 to 0.86
|
0.74 ng•h/mL
Interval 0.64 to 0.85
|
0.79 ng•h/mL
Interval 0.67 to 0.93
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimensAmprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC 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 MVC 300mg 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 MVC 300mg 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=13 Participants
Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=12 Participants
Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=13 Participants
Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV
Cmin (ng/mL)
|
0.72 ng/mL
Interval 0.44 to 1.18
|
0.46 ng/mL
Interval 0.21 to 0.99
|
0.77 ng/mL
Interval 0.45 to 1.31
|
—
|
—
|
—
|
|
Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV
Cmax (ng/mL)
|
0.89 ng/mL
Interval 0.66 to 1.21
|
0.30 ng/mL
Interval 0.17 to 0.51
|
0.93 ng/mL
Interval 0.49 to 1.74
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimensAmprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC 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 MVC 300mg 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 MVC 300mg 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=13 Participants
Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=12 Participants
Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=13 Participants
Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
AUC: Steady-state Plasma MVC PK Following Administration of RTV
|
0.87 ng•h/mL
Interval 0.61 to 1.24
|
0.34 ng•h/mL
Interval 0.2 to 0.58
|
0.98 ng•h/mL
Interval 0.61 to 1.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 through Day 49Safety/tolerability data collected 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: * MVC 300mg BID alone * FPV 1400mg BID alone * FPV 700mg/RTV 100 mg BID alone * FPV 1400mg/RTV 100mg QD alone * FPV 1400mg BID combined with MVC 300mg BID * FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID * FPV 1400mg/RTV 100mg QD combined with MVC 300mg 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-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C & D
n=6 Participants
Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E & F
n=6 Participants
Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
Group D
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
n=6 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
n=7 Participants
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
4 participants
|
1 participants
|
3 participants
|
6 participants
|
4 participants
|
7 participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group E
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group F
Serious events: 0 serious events
Other events: 7 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-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
|
Group B
n=6 participants at risk
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
|
Group C
n=6 participants at risk
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
|
Group D
n=6 participants at risk
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
|
Group E
n=6 participants at risk
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
|
Group F
n=7 participants at risk
Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting/Diarrhea
|
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.
|
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.
|
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.
|
83.3%
5/6 • 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.
|
66.7%
4/6 • 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.
|
85.7%
6/7 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash/Itching
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
General disorders
Headache/Dizzy
|
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.
|
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.
|
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
Numbness of mouth/tongue/lips
|
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.
|
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.
|
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.
|
|
General disorders
lethargy
|
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.
|
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.
|
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
night sweats
|
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.
|
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.
|
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
Dry mouth or bad taste
|
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.
|
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.
|
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.
|
|
General disorders
Restless sleep/vivid dreams
|
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.
|
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.
|
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.
|
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.
|
|
Ear and labyrinth disorders
Ear infection
|
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.
|
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.
|
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
Increased 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%
0/6 • 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.
|
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.
|
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
Erectile Dysfunction
|
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.
|
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.
|
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
Back/leg pain
|
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.
|
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.
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60