Trial Outcomes & Findings for 48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection (NCT NCT00089583)
NCT ID: NCT00089583
Last Updated: 2017-03-07
Results Overview
Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Week 48
Results posted on
2017-03-07
Participant Flow
A total of 110 participants (par.) were enrolled in the study; however, 1 par. withdrew from the study prior to the first dose of study drug and was not included in the Intent-to-Treat Exposed or Safety Populations. Therefore, 109 par. received \>=1 dose of study drug and are thus categorized as starting the study in the Participant Flow module.
Participant milestones
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
89
|
|
Overall Study
COMPLETED
|
13
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
38
|
Reasons for withdrawal
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Insufficient Viral Load Response
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Participant (Par) Didn't Take Medication
|
1
|
0
|
|
Overall Study
Participant Refused Study Medication
|
0
|
2
|
|
Overall Study
Non-Compliance
|
0
|
4
|
|
Overall Study
Poor Medical Compliance/Adherence Issues
|
0
|
3
|
|
Overall Study
Participant Management Criteria Met
|
0
|
1
|
|
Overall Study
Reason Not Provided
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Principal Investigator Decision
|
0
|
10
|
|
Overall Study
Start of Disallowed Medication
|
0
|
1
|
|
Overall Study
Necessity to Use Prohibited Drug
|
1
|
0
|
|
Overall Study
Participant Incarcerated
|
0
|
1
|
Baseline Characteristics
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
Baseline characteristics by cohort
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.9 Years
STANDARD_DEVIATION 1.07 • n=99 Participants
|
10.0 Years
STANDARD_DEVIATION 4.49 • n=107 Participants
|
8.7 Years
STANDARD_DEVIATION 4.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=99 Participants
|
43 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
19 participants
n=99 Participants
|
41 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Not Specified
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
<13 years (yrs); mildly symptomatic (S)
|
18 participants
n=99 Participants
|
26 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
<13 yrs; moderately S
|
1 participants
n=99 Participants
|
15 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
<13 yrs; severely S
|
0 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
<13 yrs; non-S
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
>=13 yrs; asymptomatic/lymphadenopathy/acute HIV
|
0 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
>=13 yrs; asymptomatic, not AIDS
|
0 participants
n=99 Participants
|
14 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
>=13 yrs; AIDS
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification
>=13 yrs; not reported
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.
Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
2 to <6 yrs, 30 mg/kg BID; n=9, 0
|
22.3 hr*µg/mL
Interval 15.3 to 32.6
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
2 to <6 yrs, 40 mg/kg BID; n=7, 0
|
24.1 hr*µg/mL
Interval 15.2 to 38.0
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
55.3 hr*µg/mL
Interval 37.9 to 80.7
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
32.3 hr*µg/mL
Interval 23.0 to 45.3
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
48.4 hr*µg/mL
Interval 38.1 to 61.4
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
6 to <12 yrs, 700/100 mg BID; n=0, 3
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
37.6 hr*µg/mL
Interval 22.2 to 63.8
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
21.8 hr*µg/mL
Interval 18.0 to 26.3
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
12 to 18 yrs, 18/3 mg BID; n=0, 3
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
41.7 hr*µg/mL
Interval 16.2 to 108.0
|
—
|
—
|
|
Plasma Amprenavir (APV) AUC (0-tau[τ])
12 to 18 yrs, 700/100 mg BID; n=0, 13
|
NA hr*µg/mL
No participants were analyzed at this dose in this age group.
|
35.3 hr*µg/mL
Interval 28.2 to 44.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
The maximum concentration at steady state (Cmax) was measured.
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV Cmax
2 to <6 yrs, 30 mg/kg BID; n=9, 0
|
7.15 Micrograms per milliliter (µg/mL)
Interval 5.05 to 10.1
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Cmax
2 to <6 yrs, 40 mg/kg BID; n=7, 0
|
6.52 Micrograms per milliliter (µg/mL)
Interval 4.47 to 9.51
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Cmax
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
8.66 Micrograms per milliliter (µg/mL)
Interval 6.08 to 12.3
|
—
|
—
|
|
Plasma APV Cmax
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
4.34 Micrograms per milliliter (µg/mL)
Interval 3.16 to 5.96
|
—
|
—
|
|
Plasma APV Cmax
6 to <12.yrs, 18/3 mg/kg BID; n=0, 12
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
6.40 Micrograms per milliliter (µg/mL)
Interval 5.02 to 8.15
|
—
|
—
|
|
Plasma APV Cmax
6 to <12 yrs, 700/100 mg BID; n=0, 3
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
5.85 Micrograms per milliliter (µg/mL)
Interval 3.94 to 8.7
|
—
|
—
|
|
Plasma APV Cmax
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
3.92 Micrograms per milliliter (µg/mL)
Interval 2.44 to 6.29
|
—
|
—
|
|
Plasma APV Cmax
12 to 18 yrs, 18/3 mg/kg BID; n=0, 4
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
4.91 Micrograms per milliliter (µg/mL)
Interval 2.69 to 8.97
|
—
|
—
|
|
Plasma APV Cmax
12 to 18 yrs, 700/100 mg BID; n=0, 13
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
4.93 Micrograms per milliliter (µg/mL)
Interval 3.83 to 6.34
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=40 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV Cτ
2 to <6 yrs, 30 mg/kg BID; n=19, 0
|
0.55 Micrograms per milliliter (µg/mL)
Interval 0.41 to 0.75
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Cτ
2 to <6 yrs, 40 mg/kg BID; n=10, 0
|
0.70 Micrograms per milliliter (µg/mL)
Interval 0.41 to 1.19
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Cτ
2 to <6 yrs, 23/3 mg/kg BID; n=0, 16
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
3.39 Micrograms per milliliter (µg/mL)
Interval 2.51 to 4.57
|
—
|
—
|
|
Plasma APV Cτ
6 to <12 yrs, 15/3 mg/kg BID; n=0, 13
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
2.24 Micrograms per milliliter (µg/mL)
Interval 1.7 to 2.93
|
—
|
—
|
|
Plasma APV Cτ
6 to <12 yrs, 18/3 mg/kg BID; n=0, 23
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
2.42 Micrograms per milliliter (µg/mL)
Interval 1.9 to 3.07
|
—
|
—
|
|
Plasma APV Cτ
6 to <12 yrs, 700/100 mg BID; n=0, 7
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
1.81 Micrograms per milliliter (µg/mL)
Interval 0.8 to 4.08
|
—
|
—
|
|
Plasma APV Cτ
12 to 18 yrs, 15/3 mg/kg BID; n=0, 6
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
1.45 Micrograms per milliliter (µg/mL)
Interval 0.56 to 3.74
|
—
|
—
|
|
Plasma APV Cτ
12 to 18 yrs, 700/100 mg BID; n=0, 40
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
2.01 Micrograms per milliliter (µg/mL)
Interval 1.74 to 2.32
|
—
|
—
|
|
Plasma APV Cτ
12 to 18 yrs, 18/3 mg/kg BID; n=0, 10
|
NA Micrograms per milliliter (µg/mL)
No participants were analyzed at this dose in this age group.
|
1.80 Micrograms per milliliter (µg/mL)
Interval 1.22 to 2.67
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
2 to <6yrs, 30 mg/kg BID; n=9, 0
|
19.3 Milliliters/minute/kilogram (mL/min/kg)
Interval 13.2 to 28.2
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
2 to <6yrs, 40 mg/kg BID; n=7, 0
|
23.4 Milliliters/minute/kilogram (mL/min/kg)
Interval 14.9 to 36.8
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
6.06 Milliliters/minute/kilogram (mL/min/kg)
Interval 4.12 to 8.91
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
6.48 Milliliters/minute/kilogram (mL/min/kg)
Interval 4.68 to 8.98
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
5.27 Milliliters/minute/kilogram (mL/min/kg)
Interval 4.16 to 6.68
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
6 to <12 yrs, 700/100 mg BID; n=0, 3
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
5.94 Milliliters/minute/kilogram (mL/min/kg)
Interval 2.59 to 13.9
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
10.1 Milliliters/minute/kilogram (mL/min/kg)
Interval 8.35 to 12.3
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
12 to 18 yrs, 18/3 mg BID; n=0, 3
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
6.00 Milliliters/minute/kilogram (mL/min/kg)
Interval 2.37 to 15.2
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg/kg
12 to 18 yrs, 700/100 mg BID; n=0, 13
|
NA Milliliters/minute/kilogram (mL/min/kg)
No participants were analyzed at this dose in this age group.
|
5.33 Milliliters/minute/kilogram (mL/min/kg)
Interval 4.26 to 6.68
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV CL/F Following Dosing Expressed in mg
2 to <6yrs, 30 mg/kg BID; n=9, 0
|
269 Milliliters per minute (mL/min)
Interval 193.0 to 376.0
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
2 to <6yrs, 40 mg/kg BID; n=7, 0
|
330 Milliliters per minute (mL/min)
Interval 203.0 to 538.0
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
91 Milliliters per minute (mL/min)
Interval 60.0 to 139.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
195 Milliliters per minute (mL/min)
Interval 136.0 to 279.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
149 Milliliters per minute (mL/min)
Interval 104.0 to 214.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
6 to <12 yrs, 700/100 mg BID; n=0, 3
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
266 Milliliters per minute (mL/min)
Interval 157.0 to 452.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
392 Milliliters per minute (mL/min)
Interval 355.0 to 432.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
12 to 18 yrs, 18/3 mg BID; n=0, 3
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
198 Milliliters per minute (mL/min)
Interval 47.0 to 838.0
|
—
|
—
|
|
Plasma APV CL/F Following Dosing Expressed in mg
12 to 18 yrs, 700/100 mg BID; n=0, 13
|
NA Milliliters per minute (mL/min)
No participants were analyzed at this dose in this age group.
|
284 Milliliters per minute (mL/min)
Interval 227.0 to 354.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV Tmax
2 to <6yrs, 30 mg/kg BID; n=9, 0
|
1.17 hours
Interval 1.0 to 3.75
|
NA hours
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Tmax
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
|
NA hours
No participants were analyzed at this dose in this age group.
|
1.25 hours
Interval 1.0 to 4.0
|
—
|
—
|
|
Plasma APV Tmax
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10
|
NA hours
No participants were analyzed at this dose in this age group.
|
2.00 hours
Interval 1.0 to 6.0
|
—
|
—
|
|
Plasma APV Tmax
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
|
NA hours
No participants were analyzed at this dose in this age group.
|
1.96 hours
Interval 0.5 to 4.0
|
—
|
—
|
|
Plasma APV Tmax
6 to <12 yrs, 700/100 mg BID; n=0, 3
|
NA hours
No participants were analyzed at this dose in this age group.
|
3.92 hours
Interval 1.0 to 4.02
|
—
|
—
|
|
Plasma APV Tmax
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA hours
No participants were analyzed at this dose in this age group.
|
1.00 hours
Interval 1.0 to 2.0
|
—
|
—
|
|
Plasma APV Tmax
2 to <6yrs, 40 mg/kg BID; n=7, 0
|
1.00 hours
Interval 0.75 to 2.0
|
NA hours
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV Tmax
12 to 18 yrs, 18/3 mg BID; n=0, 3
|
NA hours
No participants were analyzed at this dose in this age group.
|
1.50 hours
Interval 0.0 to 2.0
|
—
|
—
|
|
Plasma APV Tmax
12 to 18 yrs, 700/100 mg BID; n=0, 13
|
NA hours
No participants were analyzed at this dose in this age group.
|
2.00 hours
Interval 0.92 to 7.97
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: PK Population. Only those participants contributing data were analyzed.
The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.
Outcome measures
| Measure |
FPV Treatment Group
n=9 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma APV t1/2
2 to <6yrs, 30 mg/kg BID; n=9, 0
|
3.03 hours
Interval 2.09 to 4.41
|
NA hours
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV t1/2
2 to <6yrs, 40 mg/kg BID; n=5, 0
|
3.18 hours
Interval 2.14 to 4.73
|
NA hours
No participants were analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma APV t1/2
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
|
NA hours
No participants were analyzed at this dose in this age group.
|
5.21 hours
Interval 4.47 to 6.08
|
—
|
—
|
|
Plasma APV t1/2
6 to <12 yrs, 15/3 mg/kg BID; n=0, 7
|
NA hours
No participants were analyzed at this dose in this age group.
|
10.5 hours
Interval 8.36 to 13.1
|
—
|
—
|
|
Plasma APV t1/2
6 to <12 yrs, 700/100 mg BID; n=0, 2
|
NA hours
No participants were analyzed at this dose in this age group.
|
7.43 hours
When n\<=2, 95% CI data will not be provided.
|
—
|
—
|
|
Plasma APV t1/2
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
|
NA hours
No participants were analyzed at this dose in this age group.
|
6.12 hours
Interval 3.67 to 10.2
|
—
|
—
|
|
Plasma APV t1/2
6 to <12 yrs, 18/3 mg/kg BID; n=0, 10
|
NA hours
No participants were analyzed at this dose in this age group.
|
8.41 hours
Interval 5.9 to 12.0
|
—
|
—
|
|
Plasma APV t1/2
12 to 18 yrs, 18/3 mg BID; n=0, 4
|
NA hours
No participants were analyzed at this dose in this age group.
|
8.76 hours
Interval 2.79 to 27.5
|
—
|
—
|
|
Plasma APV t1/2
12 to 18 yrs, 700/100 mg BID; n=0, 11
|
NA hours
No participants were analyzed at this dose in this age group.
|
7.64 hours
Interval 4.84 to 12.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)
|
0 participants
|
4 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: Safety Population. Only those participants contributing data were analyzed.
Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=18 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=69 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Triglycerides; n=17, 65
|
0.1 Millimoles per liter (mmol/L)
Interval -0.2 to 0.3
|
0.2 Millimoles per liter (mmol/L)
Interval 0.0 to 0.8
|
—
|
—
|
|
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Total cholesterol; n=17, 65
|
1.1 Millimoles per liter (mmol/L)
Interval 0.8 to 1.5
|
0.9 Millimoles per liter (mmol/L)
Interval 0.2 to 1.6
|
—
|
—
|
|
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
HDL cholesterol; n=17, 65
|
0.4 Millimoles per liter (mmol/L)
Interval 0.3 to 0.7
|
0.3 Millimoles per liter (mmol/L)
Interval 0.1 to 0.4
|
—
|
—
|
|
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
LDL cholesterol; n=17, 64
|
0.6 Millimoles per liter (mmol/L)
Interval 0.3 to 1.0
|
0.5 Millimoles per liter (mmol/L)
Interval -0.1 to 1.1
|
—
|
—
|
|
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Glucose; n=18, 69
|
0.0 Millimoles per liter (mmol/L)
Interval -0.3 to 0.6
|
0.1 Millimoles per liter (mmol/L)
Interval -0.3 to 0.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: Safety Population. Only those participants contributing data were analyzed.
Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=18 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=69 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Change From Baseline in Serum Lipase at Week 48
|
-2.0 Units per liter (U/L)
Interval -5.0 to 0.0
|
-1.0 Units per liter (U/L)
Interval -7.0 to 4.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: Safety Population. Only those participants contributing data were analyzed.
Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=18 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=70 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48
ALT
|
-3 International units per liter (IU/L)
Interval -14.0 to 19.0
|
-7 International units per liter (IU/L)
Interval -16.0 to -1.0
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48
AST
|
-6 International units per liter (IU/L)
Interval -19.0 to 10.0
|
-9 International units per liter (IU/L)
Interval -17.0 to -4.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) until Week 48Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
A toxicity was considered TE if it was \> than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells \[WBCs\]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is "severe"; Grade 4 is "potentially life-threatening." ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count.
Outcome measures
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=87 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
ALT increased (inc.) (>5.0x ULN); n=20, 87
|
2 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
AST inc. (>5.0x ULN); n=20, 87
|
2 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Cholesterol (Chol.) inc. (>7.77 mmol/L); n=16, 43
|
0 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Hyperglycemia (>13.88 mmol/L); n=16, 58
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Hypoglycemia (<2.22 mmol/L); n=16, 58
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
LDL Chol. inc. (>=4.91 mmol/L); n=16, 43
|
0 participants
|
4 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Triglycerides inc. (>8.48 mmol/L); n=16, 43
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Neutropenia (<0.750 x 10^9/L); n=20, 84
|
8 participants
|
7 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Hemoglobin > anemia (<1.16 mmol/L); n=20, 85
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
PC > thrombocytopenia (<50.000 x 10^9/L); n=20, 85
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Lipase inc. (>3.0x ULN); n=19, 85
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Leucopenia (<1.500 x 10^9/L); n=20, 84
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.
Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=15 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma Ritonavir (RTV) AUC (0-τ)
2 to <6 yrs, 3 mg/kg BID; n=0, 10
|
—
|
3.98 hr*µg/mL
Interval 2.28 to 6.94
|
—
|
—
|
|
Plasma Ritonavir (RTV) AUC (0-τ)
6 to <12 yrs, 3 mg/kg BID; n=0, 12
|
—
|
7.13 hr*µg/mL
Interval 5.37 to 9.46
|
—
|
—
|
|
Plasma Ritonavir (RTV) AUC (0-τ)
12 to 18 yrs, 3 mg/kg BID; n=0, 1
|
—
|
5.74 hr*µg/mL
Only one participant was analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma Ritonavir (RTV) AUC (0-τ)
12 to 18 yrs, 100 mg BID; n=0, 15
|
—
|
6.13 hr*µg/mL
Interval 3.97 to 9.47
|
—
|
—
|
|
Plasma Ritonavir (RTV) AUC (0-τ)
6 to <12 yrs, 100 mg BID; n=0, 6
|
—
|
6.46 hr*µg/mL
Interval 3.6 to 11.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
The maximum concentration at steady state (Cmax) was measured.
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=16 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV Cmax
2 to <6 yrs, 3 mg/kg BID; n=0, 10
|
—
|
0.633 µg/mL
Interval 0.341 to 1.18
|
—
|
—
|
|
Plasma RTV Cmax
6 to <12 yrs, 3 mg/kg BID; n=0, 14
|
—
|
1.100 µg/mL
Interval 0.779 to 1.54
|
—
|
—
|
|
Plasma RTV Cmax
6 to <12.yrs, 100 mg BID; n=0, 6
|
—
|
0.980 µg/mL
Interval 0.572 to 1.68
|
—
|
—
|
|
Plasma RTV Cmax
12 to 18 yrs, 3 mg/kg BID; n=0, 3
|
—
|
0.750 µg/mL
Interval 0.203 to 2.78
|
—
|
—
|
|
Plasma RTV Cmax
12 to 18 yrs, 100 mg BID; n=0, 16
|
—
|
1.06 µg/mL
Interval 0.679 to 1.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=41 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV Cτ
6 to <12 yrs, 100 mg BID; n=0, 10
|
—
|
0.228 µg/mL
Interval 0.103 to 0.507
|
—
|
—
|
|
Plasma RTV Cτ
12 to 18 yrs, 3 mg/kg BID; n=0, 6
|
—
|
0.263 µg/mL
Interval 0.135 to 0.51
|
—
|
—
|
|
Plasma RTV Cτ
12 to 18 yrs, 100 mg BID; n=0, 41
|
—
|
0.220 µg/mL
Interval 0.177 to 0.273
|
—
|
—
|
|
Plasma RTV Cτ
2 to <6 yrs, 3 mg/kg BID; n=0, 16
|
—
|
0.224 µg/mL
Interval 0.179 to 0.279
|
—
|
—
|
|
Plasma RTV Cτ
6 to <12 yrs, 3 mg/kg BID; n=0, 24
|
—
|
0.297 µg/mL
Interval 0.227 to 0.388
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=15 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV CL/F Following Dosing Expressed in mg/kg
2 to <6yrs, 3 mg/kg BID; n=0, 10
|
—
|
12.9 mL/min/kg
Interval 7.33 to 22.7
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg/kg
6 to <12 yrs, 3 mg/kg BID; n=0, 12
|
—
|
6.81 mL/min/kg
Interval 5.14 to 9.04
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg/kg
6 to <12 yrs, 100 mg/kg BID; n=0, 12
|
—
|
5.94 mL/min/kg
Interval 3.56 to 9.94
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg/kg
12 to 18 yrs, 3 mg/kg BID; n=0, 1
|
—
|
8.61 mL/min/kg
Only one participant was analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg/kg
12 to 18 yrs, 100 mg BID; n=0, 15
|
—
|
5.59 mL/min/kg
Interval 3.9 to 8.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=15 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV CL/F Following Dosing Expressed in mg
2 to <6yrs, 3 mg/kg BID; n=0, 10
|
—
|
195 mL/min
Interval 108.0 to 353.0
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg
6 to <12 yrs, 3 mg/kg BID; n=0, 12
|
—
|
190 mL/min
Interval 142.0 to 253.0
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg
6 to <12 yrs, 100 mg/kg BID; n=0, 6
|
—
|
258 mL/min
Interval 144.0 to 463.0
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg
12 to 18 yrs, 3 mg/kg BID; n=0, 1
|
—
|
279 mL/min
Only one participant was analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma RTV CL/F Following Dosing Expressed in mg
12 to 18 yrs, 100 mg BID; n=0, 15
|
—
|
272 mL/min
Interval 176.0 to 420.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=15 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV Tmax
2 to <6 yrs, 3 mg/kg BID; n=0, 10
|
—
|
3.92 hours
Interval 1.0 to 4.07
|
—
|
—
|
|
Plasma RTV Tmax
6 to <12 yrs, 3 mg/kg BID; n=0, 14
|
—
|
4.00 hours
Interval 0.5 to 11.92
|
—
|
—
|
|
Plasma RTV Tmax
6 to <12 yrs, 100 mg BID; n=0, 6
|
—
|
4.01 hours
Interval 1.0 to 11.92
|
—
|
—
|
|
Plasma RTV Tmax
12 to 18 yrs, 3 mg/kg BID; n=0, 3
|
—
|
5.92 hours
Interval 2.03 to 6.0
|
—
|
—
|
|
Plasma RTV Tmax
12 to 18 yrs, 100 mg BID; n=0, 16
|
—
|
3.96 hours
Interval 0.92 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.
Outcome measures
| Measure |
FPV Treatment Group
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=14 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Plasma RTV t1/2
2 to <6 yrs, 3 mg/kg BID; n=0, 10
|
—
|
3.43 hours
Interval 2.61 to 4.51
|
—
|
—
|
|
Plasma RTV t1/2
6 to <12 yrs, 3 mg/kg BID; n=0, 11
|
—
|
3.39 hours
Interval 2.88 to 4.0
|
—
|
—
|
|
Plasma RTV t1/2
6 to <12 yrs, 100 mg BID; n=0, 5
|
—
|
3.97 hours
Interval 3.17 to 4.97
|
—
|
—
|
|
Plasma RTV t1/2
12 to 18 yrs, 3 mg/kg BID; n=0, 1
|
—
|
2.84 hours
Only one participant was analyzed at this dose in this age group.
|
—
|
—
|
|
Plasma RTV t1/2
12 to 18 yrs, 100 mg BID; n=0, 14
|
—
|
3.64 hours
Interval 3.09 to 4.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: PK Population
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving \>=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received \<1week's treatment with a PI) and -experienced (received \>1week prior PI therapy with no more than 3 PIs before trial enrollment) par.
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA \<400 copies/mL. Virologic failure: (1) HIV-1 RNA \>=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 \>=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.
Outcome measures
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, virological (V) success; n=20, 49
|
12 participants
|
36 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, V failure (1); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
8 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, V failure (2); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
7 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, V failure (3); n=20, 49
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, V failure (4); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
3 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, No V data at Week 48 (a); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
1 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, No V data at Week 48 (b); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
0 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, No V data at Week 48 (c); n=20, 49
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, V success; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
19 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, V failure (1); n=20, 49
|
4 participants
|
3 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, V failure (2); n=20, 49
|
2 participants
|
4 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, V failure (3); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
0 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve;, V failure (4); n=20, 49
|
1 participants
|
3 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, No V data at Week 48 (a); n=20, 49
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-naïve, No V data Week 48 (b); n=20, 49
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
PI-exp, No V data at Week 48 (c); n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1week prior PI therapy with no more than 3 PIs before trial enrollment) par.
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.
Outcome measures
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-naïve, Baseline; n=20, 49
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-naïve, Week 2; n=20, 49
|
3 participants
|
9 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-naïve, Week 12; n=20, 49
|
13 participants
|
35 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-exp, Week 12; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
19 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-naïve, Week 48; n=20, 49
|
12 participants
|
36 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-exp, Week 48; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
19 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-naïve, Week 24; n=20, 49
|
13 participants
|
35 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-exp, Week 24; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
22 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-exp, Baseline; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
0 participants
|
—
|
—
|
|
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
PI-exp, Week 2; n=0, 40
|
NA participants
No participants were analyzed for this population at this time point.
|
5 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Outcome measures
| Measure |
FPV Treatment Group
n=20 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=88 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Baseline; n=0, 39
|
NA log10 copies/mL
No participants were analyzed for this population at this time point.
|
4.53 log10 copies/mL
Interval 4.08 to 5.12
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 2; n=14, 39
|
3.27 log10 copies/mL
Interval 2.65 to 3.89
|
3.06 log10 copies/mL
Interval 2.72 to 3.39
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 2; n=0, 33
|
NA log10 copies/mL
No participants were analyzed for this population at this time point.
|
3.04 log10 copies/mL
Interval 2.66 to 3.49
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 12; n=19, 46
|
2.03 log10 copies/mL
Interval 1.69 to 2.56
|
1.94 log10 copies/mL
Interval 1.69 to 2.27
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 12; n=0, 34
|
NA log10 copies/mL
No participants were analyzed for this population at this time point.
|
2.20 log10 copies/mL
Interval 1.69 to 3.72
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 24; n=18, 44
|
1.85 log10 copies/mL
Interval 1.69 to 2.6
|
1.69 log10 copies/mL
Interval 1.69 to 1.95
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 24; n=0, 35
|
NA log10 copies/mL
No participants were analyzed for this population at this time point.
|
1.80 log10 copies/mL
Interval 1.69 to 3.29
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 48; n=0, 33
|
NA log10 copies/mL
No participants were analyzed for this population at this time point.
|
1.69 log10 copies/mL
Interval 1.69 to 3.51
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Baseline; n=20, 49
|
5.13 log10 copies/mL
Interval 4.88 to 5.6
|
4.72 log10 copies/mL
Interval 4.27 to 5.2
|
—
|
—
|
|
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 48; n=18, 44
|
1.85 log10 copies/mL
Interval 1.69 to 2.6
|
1.69 log10 copies/mL
Interval 1.69 to 1.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=79 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 2; n=14, 39
|
-1.91 log10/copies
Interval -2.26 to -1.55
|
-1.84 log10/copies
Interval -2.17 to -1.49
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 2; n=0, 32
|
NA log10/copies
No participants were analyzed for this population at this time point.
|
-1.58 log10/copies
Interval -1.97 to -0.7
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 24; n=18, 44
|
-3.16 log10/copies
Interval -3.41 to -2.46
|
-2.87 log10/copies
Interval -3.48 to -2.31
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 24; n=0, 35
|
NA log10/copies
No participants were analyzed for this population at this time point.
|
-2.28 log10/copies
Interval -3.04 to -1.21
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 12; n=19, 46
|
-3.04 log10/copies
Interval -3.21 to -2.7
|
-2.77 log10/copies
Interval -3.22 to -2.28
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 12; n=0, 33
|
NA log10/copies
No participants were analyzed for this population at this time point.
|
-2.23 log10/copies
Interval -2.85 to -1.34
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 48; n=18, 44
|
-3.02 log10/copies
Interval -3.41 to -2.46
|
-2.83 log10/copies
Interval -3.51 to -2.14
|
—
|
—
|
|
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 48; n=0, 33
|
NA log10/copies
No participants were analyzed for this population at this time point.
|
-2.14 log10/copies
Interval -3.04 to -0.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=79 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 12; n=0, 33
|
NA participants
No participants were analyzed for this population at this time point.
|
26 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 24; n=18, 44
|
18 participants
|
41 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 24; n=0, 35
|
NA participants
No participants were analyzed for this population at this time point.
|
29 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 48; n=18, 44
|
17 participants
|
40 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 48; n=0, 33
|
NA participants
No participants were analyzed for this population at this time point.
|
24 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 2; n=14, 39
|
13 participants
|
35 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-exp, Week 2; n=0, 32
|
NA participants
No participants were analyzed for this population at this time point.
|
22 participants
|
—
|
—
|
|
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
PI-naïve, Week 12; n=19, 46
|
19 participants
|
41 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-exp, Week 12; n= 0, 31
|
NA Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 0
No participants were analyzed for this population at this time point.
|
720 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 379.84 • Interval 380.0 to 870.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-naïve, Baseline; n= 19, 49
|
810 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 387.42 • Interval 460.0 to 1000.0
|
370 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 399.39 • Interval 200.0 to 670.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-naïve, Week 12; n= 19, 46
|
1040 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 606.25 • Interval 600.0 to 1440.0
|
581 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 555.52 • Interval 310.0 to 890.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-exp, Week 2; n= 0, 32
|
NA Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 0
No participants were analyzed for this population at this time point.
|
605 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 444.63 • Interval 270.0 to 755.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-exp, Week 24; n= 0, 34
|
NA Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 0
No participants were analyzed for this population at this time point.
|
620 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 420.62 • Interval 370.0 to 790.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-naïve, Week 2; n= 13, 41
|
820 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 370.81 • Interval 760.0 to 1120.0
|
450 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 575.73 • Interval 300.0 to 781.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-naïve, Week 24; n= 18, 44
|
1260 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 482.92 • Interval 1050.0 to 1640.0
|
609 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 509.24 • Interval 341.0 to 905.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-naïve, Week 48; n= 18, 42
|
1080 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 611.28 • Interval 570.0 to 1400.0
|
670 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 568.20 • Interval 433.0 to 910.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-exp, Baseline; n= 0, 40
|
NA Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 0
No participants were analyzed for this population at this time point.
|
440 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 562.00 • Interval 220.0 to 685.0
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
PI-exp, Week 48; n= 0, 29
|
NA Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 0
No participants were analyzed for this population at this time point.
|
540 Cells per cubic millimeter (cells/cu mm)
Inter-Quartile Range 297.80 • Interval 350.0 to 640.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=78 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-naïve, Week 12; n=19, 46
|
170 cells/cu mm
Interval 50.0 to 490.0
|
180 cells/cu mm
Interval 60.0 to 269.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-naïve, Week 24; n=18, 44
|
350 cells/cu mm
Interval 110.0 to 640.0
|
184 cells/cu mm
Interval 53.0 to 367.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-naïve, Week 48; n=17, 42
|
340 cells/cu mm
Interval -40.0 to 470.0
|
217 cells/cu mm
Interval 100.0 to 398.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-exp, Week 2; n=0, 32
|
NA cells/cu mm
No participants were analyzed for this population at this time point.
|
90 cells/cu mm
Interval 2.0 to 190.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-exp, Week 12; n=0, 31
|
NA cells/cu mm
No participants were analyzed for this population at this time point.
|
200 cells/cu mm
Interval 70.0 to 340.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-exp, Week 48; n=0, 29
|
NA cells/cu mm
No participants were analyzed for this population at this time point.
|
180 cells/cu mm
Interval 0.0 to 270.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-naïve, Week 2; n=13, 41
|
20 cells/cu mm
Interval -20.0 to 180.0
|
60 cells/cu mm
Interval 0.0 to 160.0
|
—
|
—
|
|
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
PI-exp, Week 24; n=0, 34
|
NA cells/cu mm
No participants were analyzed for this population at this time point.
|
150 cells/cu mm
Interval 10.0 to 260.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 12, 24, and 48Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-naïve, Baseline; n=19, 49
|
19 Percentage of TLs that are CD4+ cells
Interval 18.0 to 27.0
|
21 Percentage of TLs that are CD4+ cells
Interval 14.0 to 29.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-naïve, Week 12; n=19, 46
|
27 Percentage of TLs that are CD4+ cells
Interval 24.0 to 33.0
|
25 Percentage of TLs that are CD4+ cells
Interval 17.0 to 33.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-naïve, Week 48; n=18, 42
|
32 Percentage of TLs that are CD4+ cells
Interval 27.0 to 34.0
|
29 Percentage of TLs that are CD4+ cells
Interval 24.0 to 36.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-exp, Baseline; n=0, 40
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
24 Percentage of TLs that are CD4+ cells
Interval 11.0 to 30.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-exp, Week 12; n=0, 31
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
23 Percentage of TLs that are CD4+ cells
Interval 15.0 to 34.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-exp, Week 24; n=0, 34
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
23 Percentage of TLs that are CD4+ cells
Interval 17.0 to 34.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-exp, Week 48; n=0, 29
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
24 Percentage of TLs that are CD4+ cells
Interval 15.0 to 32.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-naïve, Week 2; n=13, 41
|
24 Percentage of TLs that are CD4+ cells
Interval 22.0 to 25.0
|
23 Percentage of TLs that are CD4+ cells
Interval 18.0 to 30.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-naïve, Week 24; n=18, 44
|
31 Percentage of TLs that are CD4+ cells
Interval 26.0 to 34.0
|
28 Percentage of TLs that are CD4+ cells
Interval 19.0 to 36.0
|
—
|
—
|
|
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
PI-exp, Week 2; n=0, 32
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
22 Percentage of TLs that are CD4+ cells
Interval 14.0 to 33.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 12, 24, 48Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.
Outcome measures
| Measure |
FPV Treatment Group
n=19 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=78 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-naïve, Week 2; n=13, 41
|
3 Percentage of TLs that are CD4+ cells
Interval 0.0 to 5.0
|
1 Percentage of TLs that are CD4+ cells
Interval -1.0 to 4.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-naïve, Week 12; n=19, 46
|
6 Percentage of TLs that are CD4+ cells
Interval 2.0 to 7.0
|
5 Percentage of TLs that are CD4+ cells
Interval 1.0 to 7.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-naïve, Week 24; n=18, 44
|
7 Percentage of TLs that are CD4+ cells
Interval 3.0 to 11.0
|
8 Percentage of TLs that are CD4+ cells
Interval 4.0 to 10.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-naïve, Week 48; n=17, 42
|
8 Percentage of TLs that are CD4+ cells
Interval 4.0 to 11.0
|
10 Percentage of TLs that are CD4+ cells
Interval 5.0 to 14.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-exp, Week 2; n=0, 32
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
2 Percentage of TLs that are CD4+ cells
Interval 0.0 to 5.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-exp, Week 12; n=0, 31
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
3 Percentage of TLs that are CD4+ cells
Interval 2.0 to 7.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-exp, Week 24; n=0, 34
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
5 Percentage of TLs that are CD4+ cells
Interval 1.0 to 8.0
|
—
|
—
|
|
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
PI-exp, Week 48; n=0, 29
|
NA Percentage of TLs that are CD4+ cells
No participants were analyzed for this population at this time point.
|
6 Percentage of TLs that are CD4+ cells
Interval 2.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.
A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.
Outcome measures
| Measure |
FPV Treatment Group
n=3 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=1 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
n=3 Participants
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
n=8 Participants
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any HIV NRTI Mutation
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NRTI mutation M184V
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any HIV NNRTI Mutation
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NNRTI Mutation V179D/E
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any HIV Major PI Mutations
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation M46M/I
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation M46M/L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I50I/V
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I54I/L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I54I/M
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I54I/M/V
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation Q58Q/E
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation V82A/V
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation V82F/I
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I84I/V
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any Minor HIV PI Mutations
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation L10L/F
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation K20K/R
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation L33L/F
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation K43K/T
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation F53F/L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation F53L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation I62I/V
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation A71I/V
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation I85I/V
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: After Week 48 through Week 240Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.
A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.
Outcome measures
| Measure |
FPV Treatment Group
n=1 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=1 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
n=5 Participants
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any HIV NRTI Mutation
|
1 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NRTI mutation M41L
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NRTI mutation M184V
|
1 Participants
|
0 Participants
|
—
|
2 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any Major HIV NNRTI Mutation
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NNRTI Mutation K103N
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any Minor HIV NNRTI Mutation
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any HIV Major PI Mutations
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation V32I
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation M46L
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I47IV
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation T74P
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV Major PI Mutation I84I/V
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Any Minor HIV PI Mutations
|
1 Participants
|
0 Participants
|
—
|
2 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation L10F
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation L33F
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation I62I/V
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Minor HIV PI Mutation I85V
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NRTI mutation M184I
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NRTI mutation T215S/Y
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
HIV NNRTI Mutation V179D/E
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 48 WeeksPopulation: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable
A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.
Outcome measures
| Measure |
FPV Treatment Group
n=3 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=1 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
n=3 Participants
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
n=8 Participants
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Lamivudine
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any NRTI
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Abacavir
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Didanosine
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Emtricitabine
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any NNRTI
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any PI
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Unboosted Fosamprenavir
|
2 participants
|
NA participants
These participants took RTV-boosted FPV.
|
NA participants
These participants took RTV-boosted FPV.
|
NA participants
These participants took RTV-boosted FPV.
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Ritonavir- boosted Fosamprenavir
|
NA participants
These participants took unboosted FPV.
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Ritonavir
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 60 through Week 240Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable
A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.
Outcome measures
| Measure |
FPV Treatment Group
n=1 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=1 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
n=5 Participants
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any NRTI
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Abacavir
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Didanosine
|
0 Participants
|
1 Participants
|
—
|
3 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Emtricitabine
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Lamivudine
|
1 Participants
|
1 Participants
|
—
|
2 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Zidovudine
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any NNRTI
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Delaviridine
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Efavirenz
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Nevirapine
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Any PI
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Unboosted Fosamprenavir
|
1 Participants
|
NA Participants
These participants took RTV-boosted FPV.
|
—
|
NA Participants
These participants took RTV-boosted FPV
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Ritonavir- boosted Fosamprenavir
|
NA Participants
These participants took unboosted FPV.
|
0 Participants
|
—
|
1 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Nelfinavir
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Tipranavir
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 12, 24, and 48Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.
Outcome measures
| Measure |
FPV Treatment Group
n=17 Participants
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=59 Participants
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
PI Naïve, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
PI Experienced, ART Experienced, FPV/RTV Treatment Group
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
|
|---|---|---|---|---|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 12, 2 to <6 yrs; n= 16, 16
|
15 participants
|
14 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 12, 6 to <12 yrs; n= 0, 24
|
NA participants
No participants were analyzed for this population at this time point.
|
20 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 12, 12 to 18 yrs; n= 0, 15
|
NA participants
No participants were analyzed for this population at this time point.
|
11 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 24, Total Population; n= 16, 54
|
16 participants
|
43 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 24, 2 to <6 yrs; n= 16, 14
|
16 participants
|
11 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 24, 6 to <12 yrs; n= 0, 24
|
NA participants
No participants were analyzed for this population at this time point.
|
23 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 2, Total Population; n= 17, 59
|
15 participants
|
49 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 2, 2 to <6 years (yrs); n= 17, 16
|
15 participants
|
15 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 24, 12 to 18 yrs; n= 0, 16
|
NA participants
No participants were analyzed for this population at this time point.
|
9 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 48, Total Population; n= 15, 53
|
13 participants
|
42 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 48, 2 to <6 yrs; n= 15, 14
|
13 participants
|
13 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 48, 6 to <12 yrs; n= 0, 23
|
NA participants
No participants were analyzed for this population at this time point.
|
20 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 48, 12 to 18 yrs; n= 0, 16
|
NA participants
No participants were analyzed for this population at this time point.
|
9 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 2, 6 to <12 yrs; n= 0, 25
|
NA participants
No participants were analyzed for this population at this time point.
|
22 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 2, 12 to 18 yrs; n= 0, 18
|
NA participants
No participants were analyzed for this population at this time point.
|
12 participants
|
—
|
—
|
|
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
Week 12, Total Population; n= 16, 55
|
15 participants
|
45 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: PK Population
No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.
Outcome measures
Outcome data not reported
Adverse Events
FPV Treatment Group
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
FPV/RTV Treatment Group
Serious events: 13 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FPV Treatment Group
n=20 participants at risk
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 participants at risk
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
15.0%
3/20
|
6.7%
6/89
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20
|
2.2%
2/89
|
|
Infections and infestations
Respiratory tract infection
|
5.0%
1/20
|
1.1%
1/89
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20
|
1.1%
1/89
|
|
Infections and infestations
Ear infection
|
0.00%
0/20
|
1.1%
1/89
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20
|
0.00%
0/89
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/20
|
1.1%
1/89
|
|
Infections and infestations
Measles
|
0.00%
0/20
|
1.1%
1/89
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/20
|
1.1%
1/89
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20
|
1.1%
1/89
|
|
General disorders
Adverse drug reaction
|
0.00%
0/20
|
1.1%
1/89
|
|
General disorders
Pyrexia
|
0.00%
0/20
|
1.1%
1/89
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20
|
1.1%
1/89
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20
|
1.1%
1/89
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/20
|
1.1%
1/89
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20
|
1.1%
1/89
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/20
|
1.1%
1/89
|
Other adverse events
| Measure |
FPV Treatment Group
n=20 participants at risk
Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
|
FPV/RTV Treatment Group
n=89 participants at risk
HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
60.0%
12/20
|
31.5%
28/89
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20
|
37.1%
33/89
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20
|
29.2%
26/89
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20
|
22.5%
20/89
|
|
General disorders
Pyrexia
|
5.0%
1/20
|
21.3%
19/89
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20
|
18.0%
16/89
|
|
Infections and infestations
Respiratory tract infection
|
60.0%
12/20
|
4.5%
4/89
|
|
Infections and infestations
Rhinitis
|
10.0%
2/20
|
16.9%
15/89
|
|
Infections and infestations
Bronchitis
|
15.0%
3/20
|
13.5%
12/89
|
|
Infections and infestations
Ear infection
|
15.0%
3/20
|
12.4%
11/89
|
|
Nervous system disorders
Headache
|
0.00%
0/20
|
15.7%
14/89
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20
|
15.7%
14/89
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
|
11.2%
10/89
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20
|
11.2%
10/89
|
|
Infections and infestations
Otitis media
|
0.00%
0/20
|
12.4%
11/89
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
|
10.1%
9/89
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20
|
9.0%
8/89
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20
|
9.0%
8/89
|
|
Infections and infestations
Gasrtroenteritis
|
0.00%
0/20
|
7.9%
7/89
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20
|
7.9%
7/89
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20
|
7.9%
7/89
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20
|
9.0%
8/89
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20
|
5.6%
5/89
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20
|
6.7%
6/89
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20
|
6.7%
6/89
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/20
|
6.7%
6/89
|
Additional Information
GSK Response Center
ViiV Healthcare
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER