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48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection

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ClinicalTrials.gov Identifier: NCT00089583
Recruitment Status : Completed
First Posted : August 10, 2004
Results First Posted : June 21, 2012
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus I
Interventions Drug: LEXIVA (GW433908)
Drug: Ritonavir
Enrollment 110
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 20 89
Completed 13 51
Not Completed 7 38
Reason Not Completed
Adverse Event             0             3
Insufficient Viral Load Response             5             5
Withdrawal by Subject             0             4
Participant (Par) Didn't Take Medication             1             0
Participant Refused Study Medication             0             2
Non-Compliance             0             4
Poor Medical Compliance/Adherence Issues             0             3
Participant Management Criteria Met             0             1
Reason Not Provided             0             1
Protocol Violation             0             3
Principal Investigator Decision             0             10
Start of Disallowed Medication             0             1
Necessity to Use Prohibited Drug             1             0
Participant Incarcerated             0             1
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 20 89 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 89 participants 109 participants
2.9  (1.07) 10.0  (4.49) 8.7  (4.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 89 participants 109 participants
Female
15
  75.0%
43
  48.3%
58
  53.2%
Male
5
  25.0%
46
  51.7%
51
  46.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 89 participants 109 participants
Arabic/North African 0 1 1
Black 0 43 43
South Asian 0 1 1
White/Caucasian 19 41 60
Race Not Specified 1 3 4
Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 89 participants 109 participants
<13 years (yrs); mildly symptomatic (S) 18 26 44
<13 yrs; moderately S 1 15 16
<13 yrs; severely S 0 10 10
<13 yrs; non-S 1 5 6
>=13 yrs; asymptomatic/lymphadenopathy/acute HIV 0 12 12
>=13 yrs; asymptomatic, not AIDS 0 14 14
>=13 yrs; AIDS 0 5 5
>=13 yrs; not reported 0 2 2
[1]
Measure Description: The adult/adolescent (>=13 years) HIV infection CDC classification system was based on 3 categories (Cat). Cat A, asymptomatic acute/primary HIV infection or persistent generalized lymphadenopathy. Cat B, symptomatic conditions not included in Cat A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Cat C, acquired immune deficiency syndrome (AIDS)-defining conditions. Infected children (<13 years) are classified into mutually exclusive categories per 3 parameters: infection, clinical, and immunologic status.
1.Primary Outcome
Title Plasma Amprenavir (APV) AUC (0-tau[τ])
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*µg/mL
2 to <6 yrs, 30 mg/kg BID; n=9, 0
22.3
(15.3 to 32.6)
NA [1] 
(NA to NA)
2 to <6 yrs, 40 mg/kg BID; n=7, 0
24.1
(15.2 to 38.0)
NA [1] 
(NA to NA)
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
55.3
(37.9 to 80.7)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
NA [1] 
(NA to NA)
32.3
(23.0 to 45.3)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
NA [1] 
(NA to NA)
48.4
(38.1 to 61.4)
6 to <12 yrs, 700/100 mg BID; n=0, 3
NA [1] 
(NA to NA)
37.6
(22.2 to 63.8)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
21.8
(18.0 to 26.3)
12 to 18 yrs, 18/3 mg BID; n=0, 3
NA [1] 
(NA to NA)
41.7
(16.2 to 108)
12 to 18 yrs, 700/100 mg BID; n=0, 13
NA [1] 
(NA to NA)
35.3
(28.2 to 44.1)
[1]
No participants were analyzed at this dose in this age group.
2.Primary Outcome
Title Plasma APV Cmax
Hide Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Micrograms per milliliter (µg/mL)
2 to <6 yrs, 30 mg/kg BID; n=9, 0
7.15
(5.05 to 10.10)
NA [1] 
(NA to NA)
2 to <6 yrs, 40 mg/kg BID; n=7, 0
6.52
(4.47 to 9.51)
NA [1] 
(NA to NA)
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
8.66
(6.08 to 12.30)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10
NA [1] 
(NA to NA)
4.34
(3.16 to 5.96)
6 to <12.yrs, 18/3 mg/kg BID; n=0, 12
NA [1] 
(NA to NA)
6.40
(5.02 to 8.15)
6 to <12 yrs, 700/100 mg BID; n=0, 3
NA [1] 
(NA to NA)
5.85
(3.94 to 8.70)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
3.92
(2.44 to 6.29)
12 to 18 yrs, 18/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
4.91
(2.69 to 8.97)
12 to 18 yrs, 700/100 mg BID; n=0, 13
NA [1] 
(NA to NA)
4.93
(3.83 to 6.34)
[1]
No participants were analyzed at this dose in this age group.
3.Primary Outcome
Title Plasma APV Cτ
Hide Description The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Micrograms per milliliter (µg/mL)
2 to <6 yrs, 30 mg/kg BID; n=19, 0
0.55
(0.41 to 0.75)
NA [1] 
(NA to NA)
2 to <6 yrs, 40 mg/kg BID; n=10, 0
0.70
(0.41 to 1.19)
NA [1] 
(NA to NA)
2 to <6 yrs, 23/3 mg/kg BID; n=0, 16
NA [1] 
(NA to NA)
3.39
(2.51 to 4.57)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 13
NA [1] 
(NA to NA)
2.24
(1.70 to 2.93)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 23
NA [1] 
(NA to NA)
2.42
(1.90 to 3.07)
6 to <12 yrs, 700/100 mg BID; n=0, 7
NA [1] 
(NA to NA)
1.81
(0.80 to 4.08)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 6
NA [1] 
(NA to NA)
1.45
(0.56 to 3.74)
12 to 18 yrs, 18/3 mg/kg BID; n=0, 10
NA [1] 
(NA to NA)
1.80
(1.22 to 2.67)
12 to 18 yrs, 700/100 mg BID; n=0, 40
NA [1] 
(NA to NA)
2.01
(1.74 to 2.32)
[1]
No participants were analyzed at this dose in this age group.
4.Primary Outcome
Title Plasma APV CL/F Following Dosing Expressed in mg/kg
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters/minute/kilogram (mL/min/kg)
2 to <6yrs, 30 mg/kg BID; n=9, 0
19.3
(13.2 to 28.2)
NA [1] 
(NA to NA)
2 to <6yrs, 40 mg/kg BID; n=7, 0
23.4
(14.9 to 36.8)
NA [1] 
(NA to NA)
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
6.06
(4.12 to 8.91)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
NA [1] 
(NA to NA)
6.48
(4.68 to 8.98)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
NA [1] 
(NA to NA)
5.27
(4.16 to 6.68)
6 to <12 yrs, 700/100 mg BID; n=0, 3
NA [1] 
(NA to NA)
5.94
(2.59 to 13.9)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
10.1
(8.35 to 12.3)
12 to 18 yrs, 18/3 mg BID; n=0, 3
NA [1] 
(NA to NA)
6.00
(2.37 to 15.2)
12 to 18 yrs, 700/100 mg BID; n=0, 13
NA [1] 
(NA to NA)
5.33
(4.26 to 6.68)
[1]
No participants were analyzed at this dose in this age group.
5.Primary Outcome
Title Plasma APV CL/F Following Dosing Expressed in mg
Hide Description 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).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters per minute (mL/min)
2 to <6yrs, 30 mg/kg BID; n=9, 0
269
(193 to 376)
NA [1] 
(NA to NA)
2 to <6yrs, 40 mg/kg BID; n=7, 0
330
(203 to 538)
NA [1] 
(NA to NA)
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
91
(60 to 139)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9
NA [1] 
(NA to NA)
195
(136 to 279)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
NA [1] 
(NA to NA)
149
(104 to 214)
6 to <12 yrs, 700/100 mg BID; n=0, 3
NA [1] 
(NA to NA)
266
(157 to 452)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
392
(355 to 432)
12 to 18 yrs, 18/3 mg BID; n=0, 3
NA [1] 
(NA to NA)
198
(47 to 838)
12 to 18 yrs, 700/100 mg BID; n=0, 13
NA [1] 
(NA to NA)
284
(227 to 354)
[1]
No participants were analyzed at this dose in this age group.
6.Primary Outcome
Title Plasma APV Tmax
Hide Description The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Median (Full Range)
Unit of Measure: hours
2 to <6yrs, 30 mg/kg BID; n=9, 0
1.17
(1.00 to 3.75)
NA [1] 
(NA to NA)
2 to <6yrs, 40 mg/kg BID; n=7, 0
1.00
(0.75 to 2.00)
NA [1] 
(NA to NA)
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
1.25
(1.00 to 4.00)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10
NA [1] 
(NA to NA)
2.00
(1.00 to 6.00)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12
NA [1] 
(NA to NA)
1.96
(0.50 to 4.00)
6 to <12 yrs, 700/100 mg BID; n=0, 3
NA [1] 
(NA to NA)
3.92
(1.00 to 4.02)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
1.00
(1.00 to 2.00)
12 to 18 yrs, 18/3 mg BID; n=0, 3
NA [1] 
(NA to NA)
1.50
(0.00 to 2.00)
12 to 18 yrs, 700/100 mg BID; n=0, 13
NA [1] 
(NA to NA)
2.00
(0.92 to 7.97)
[1]
No participants were analyzed at this dose in this age group.
7.Primary Outcome
Title Plasma APV t1/2
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 9 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours
2 to <6yrs, 30 mg/kg BID; n=9, 0
3.03
(2.09 to 4.41)
NA [1] 
(NA to NA)
2 to <6yrs, 40 mg/kg BID; n=5, 0
3.18
(2.14 to 4.73)
NA [1] 
(NA to NA)
2 to <6yrs, 23/3 mg/kg BID; n=0, 14
NA [1] 
(NA to NA)
5.21
(4.47 to 6.08)
6 to <12 yrs, 15/3 mg/kg BID; n=0, 7
NA [1] 
(NA to NA)
10.5
(8.36 to 13.1)
6 to <12 yrs, 18/3 mg/kg BID; n=0, 10
NA [1] 
(NA to NA)
8.41
(5.90 to 12.0)
6 to <12 yrs, 700/100 mg BID; n=0, 2
NA [1] 
(NA to NA)
7.43 [2] 
(NA to NA)
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4
NA [1] 
(NA to NA)
6.12
(3.67 to 10.2)
12 to 18 yrs, 18/3 mg BID; n=0, 4
NA [1] 
(NA to NA)
8.76
(2.79 to 27.5)
12 to 18 yrs, 700/100 mg BID; n=0, 11
NA [1] 
(NA to NA)
7.64
(4.84 to 12.0)
[1]
No participants were analyzed at this dose in this age group.
[2]
When n<=2, 95% CI data will not be provided.
8.Primary Outcome
Title Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 20 89
Measure Type: Number
Unit of Measure: participants
0 4
9.Primary Outcome
Title Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Hide Description 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.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 18 69
Median (Inter-Quartile Range)
Unit of Measure: Millimoles per liter (mmol/L)
Triglycerides; n=17, 65
0.1
(-0.2 to 0.3)
0.2
(0.0 to 0.8)
Total cholesterol; n=17, 65
1.1
(0.8 to 1.5)
0.9
(0.2 to 1.6)
HDL cholesterol; n=17, 65
0.4
(0.3 to 0.7)
0.3
(0.1 to 0.4)
LDL cholesterol; n=17, 64
0.6
(0.3 to 1.0)
0.5
(-0.1 to 1.1)
Glucose; n=18, 69
0.0
(-0.3 to 0.6)
0.1
(-0.3 to 0.5)
10.Primary Outcome
Title Change From Baseline in Serum Lipase at Week 48
Hide Description 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.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 18 69
Median (Inter-Quartile Range)
Unit of Measure: Units per liter (U/L)
-2.0
(-5.0 to 0.0)
-1.0
(-7.0 to 4.0)
11.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48
Hide Description 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.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 18 70
Median (Inter-Quartile Range)
Unit of Measure: International units per liter (IU/L)
ALT
-3
(-14 to 19)
-7
(-16 to -1)
AST
-6
(-19 to 10)
-9
(-17 to -4)
12.Primary Outcome
Title Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Hide Description 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.
Time Frame Baseline (Day 1) until Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 20 87
Measure Type: Number
Unit of Measure: participants
ALT increased (inc.) (>5.0x ULN); n=20, 87 2 2
AST inc. (>5.0x ULN); n=20, 87 2 2
Cholesterol (Chol.) inc. (>7.77 mmol/L); n=16, 43 0 2
Hyperglycemia (>13.88 mmol/L); n=16, 58 0 0
Hypoglycemia (<2.22 mmol/L); n=16, 58 0 0
LDL Chol. inc. (>=4.91 mmol/L); n=16, 43 0 4
Triglycerides inc. (>8.48 mmol/L); n=16, 43 0 0
Lipase inc. (>3.0x ULN); n=19, 85 0 0
Leucopenia (<1.500 x 10^9/L); n=20, 84 0 0
Neutropenia (<0.750 x 10^9/L); n=20, 84 8 7
Hemoglobin > anemia (<1.16 mmol/L); n=20, 85 0 0
PC > thrombocytopenia (<50.000 x 10^9/L); n=20, 85 0 1
13.Secondary Outcome
Title Plasma Ritonavir (RTV) AUC (0-τ)
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*µg/mL
2 to <6 yrs, 3 mg/kg BID; n=0, 10
3.98
(2.28 to 6.94)
6 to <12 yrs, 3 mg/kg BID; n=0, 12
7.13
(5.37 to 9.46)
6 to <12 yrs, 100 mg BID; n=0, 6
6.46
(3.60 to 11.6)
12 to 18 yrs, 3 mg/kg BID; n=0, 1
5.74 [1] 
(NA to NA)
12 to 18 yrs, 100 mg BID; n=0, 15
6.13
(3.97 to 9.47)
[1]
Only one participant was analyzed at this dose in this age group.
14.Secondary Outcome
Title Plasma RTV Cmax
Hide Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 16
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
2 to <6 yrs, 3 mg/kg BID; n=0, 10
0.633
(0.341 to 1.18)
6 to <12 yrs, 3 mg/kg BID; n=0, 14
1.100
(0.779 to 1.54)
6 to <12.yrs, 100 mg BID; n=0, 6
0.980
(0.572 to 1.68)
12 to 18 yrs, 3 mg/kg BID; n=0, 3
0.750
(0.203 to 2.78)
12 to 18 yrs, 100 mg BID; n=0, 16
1.06
(0.679 to 1.67)
15.Secondary Outcome
Title Plasma RTV Cτ
Hide Description The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
2 to <6 yrs, 3 mg/kg BID; n=0, 16
0.224
(0.179 to 0.279)
6 to <12 yrs, 3 mg/kg BID; n=0, 24
0.297
(0.227 to 0.388)
6 to <12 yrs, 100 mg BID; n=0, 10
0.228
(0.103 to 0.507)
12 to 18 yrs, 3 mg/kg BID; n=0, 6
0.263
(0.135 to 0.510)
12 to 18 yrs, 100 mg BID; n=0, 41
0.220
(0.177 to 0.273)
16.Secondary Outcome
Title Plasma RTV CL/F Following Dosing Expressed in mg/kg
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min/kg
2 to <6yrs, 3 mg/kg BID; n=0, 10
12.9
(7.33 to 22.7)
6 to <12 yrs, 3 mg/kg BID; n=0, 12
6.81
(5.14 to 9.04)
6 to <12 yrs, 100 mg/kg BID; n=0, 12
5.94
(3.56 to 9.94)
12 to 18 yrs, 3 mg/kg BID; n=0, 1
8.61 [1] 
(NA to NA)
12 to 18 yrs, 100 mg BID; n=0, 15
5.59
(3.90 to 8.01)
[1]
Only one participant was analyzed at this dose in this age group.
17.Secondary Outcome
Title Plasma RTV CL/F Following Dosing Expressed in mg
Hide Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min
2 to <6yrs, 3 mg/kg BID; n=0, 10
195
(108 to 353)
6 to <12 yrs, 3 mg/kg BID; n=0, 12
190
(142 to 253)
6 to <12 yrs, 100 mg/kg BID; n=0, 6
258
(144 to 463)
12 to 18 yrs, 3 mg/kg BID; n=0, 1
279 [1] 
(NA to NA)
12 to 18 yrs, 100 mg BID; n=0, 15
272
(176 to 420)
[1]
Only one participant was analyzed at this dose in this age group.
18.Secondary Outcome
Title Plasma RTV Tmax
Hide Description The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 15
Median (Full Range)
Unit of Measure: hours
2 to <6 yrs, 3 mg/kg BID; n=0, 10
3.92
(1.00 to 4.07)
6 to <12 yrs, 3 mg/kg BID; n=0, 14
4.00
(0.50 to 11.92)
6 to <12 yrs, 100 mg BID; n=0, 6
4.01
(1.00 to 11.92)
12 to 18 yrs, 3 mg/kg BID; n=0, 3
5.92
(2.03 to 6.00)
12 to 18 yrs, 100 mg BID; n=0, 16
3.96
(0.92 to 6.00)
19.Secondary Outcome
Title Plasma RTV t1/2
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours
2 to <6 yrs, 3 mg/kg BID; n=0, 10
3.43
(2.61 to 4.51)
6 to <12 yrs, 3 mg/kg BID; n=0, 11
3.39
(2.88 to 4.00)
6 to <12 yrs, 100 mg BID; n=0, 5
3.97
(3.17 to 4.97)
12 to 18 yrs, 3 mg/kg BID; n=0, 1
2.84 [1] 
(NA to NA)
12 to 18 yrs, 100 mg BID; n=0, 14
3.64
(3.09 to 4.29)
[1]
Only one participant was analyzed at this dose in this age group.
20.Secondary Outcome
Title Plasma FPV AUC (0-τ)
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Plasma FPV Cmax and Cτ
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Plasma FPV CL/F Following Dosing Expressed in mg/kg
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Plasma FPV CL/F Following Dosing Expressed in mg
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Plasma FPV Tmax
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Plasma FPV t1/2
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 20 89
Measure Type: Number
Unit of Measure: participants
PI-naïve, virological (V) success; n=20, 49 12 36
PI-exp, V success; n=0, 40 NA [1]  19
PI-naïve, V failure (1); n=20, 49 4 3
PI-exp, V failure (1); n=0, 40 NA [1]  8
PI-naïve, V failure (2); n=20, 49 2 4
PI-exp, V failure (2); n=0, 40 NA [1]  7
PI-naïve, V failure (3); n=20, 49 1 0
PI-exp, V failure (3); n=0, 40 NA [1]  0
PI-naïve;, V failure (4); n=20, 49 1 3
PI-exp, V failure (4); n=0, 40 NA [1]  3
PI-naïve, No V data at Week 48 (a); n=20, 49 0 1
PI-exp, No V data at Week 48 (a); n=0, 40 NA [1]  1
PI-naïve, No V data Week 48 (b); n=20, 49 0 1
PI-exp, No V data at Week 48 (b); n=0, 40 NA [1]  0
PI-naïve, No V data at Week 48 (c); n=20, 49 0 1
PI-exp, No V data at Week 48 (c); n=0, 40 NA [1]  2
[1]
No participants were analyzed for this population at this time point.
27.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 20 89
Measure Type: Number
Unit of Measure: participants
PI-naïve, Baseline; n=20, 49 0 0
PI-exp, Baseline; n=0, 40 NA [1]  0
PI-naïve, Week 2; n=20, 49 3 9
PI-exp, Week 2; n=0, 40 NA [1]  5
PI-naïve, Week 12; n=20, 49 13 35
PI-exp, Week 12; n=0, 40 NA [1]  19
PI-naïve, Week 24; n=20, 49 13 35
PI-exp, Week 24; n=0, 40 NA [1]  22
PI-naïve, Week 48; n=20, 49 12 36
PI-exp, Week 48; n=0, 40 NA [1]  19
[1]
No participants were analyzed for this population at this time point.
28.Secondary Outcome
Title Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
Hide Description Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 20 88
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
PI-naïve, Baseline; n=20, 49
5.13
(4.88 to 5.60)
4.72
(4.27 to 5.20)
PI-exp, Baseline; n=0, 39
NA [1] 
(NA to NA)
4.53
(4.08 to 5.12)
PI-naïve, Week 2; n=14, 39
3.27
(2.65 to 3.89)
3.06
(2.72 to 3.39)
PI-exp, Week 2; n=0, 33
NA [1] 
(NA to NA)
3.04
(2.66 to 3.49)
PI-naïve, Week 12; n=19, 46
2.03
(1.69 to 2.56)
1.94
(1.69 to 2.27)
PI-exp, Week 12; n=0, 34
NA [1] 
(NA to NA)
2.20
(1.69 to 3.72)
PI-naïve, Week 24; n=18, 44
1.85
(1.69 to 2.60)
1.69
(1.69 to 1.95)
PI-exp, Week 24; n=0, 35
NA [1] 
(NA to NA)
1.80
(1.69 to 3.29)
PI-naïve, Week 48; n=18, 44
1.85
(1.69 to 2.60)
1.69
(1.69 to 1.82)
PI-exp, Week 48; n=0, 33
NA [1] 
(NA to NA)
1.69
(1.69 to 3.51)
[1]
No participants were analyzed for this population at this time point.
29.Secondary Outcome
Title Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
Hide Description 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.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 79
Median (Inter-Quartile Range)
Unit of Measure: log10/copies
PI-naïve, Week 2; n=14, 39
-1.91
(-2.26 to -1.55)
-1.84
(-2.17 to -1.49)
PI-exp, Week 2; n=0, 32
NA [1] 
(NA to NA)
-1.58
(-1.97 to -0.70)
PI-naïve, Week 12; n=19, 46
-3.04
(-3.21 to -2.70)
-2.77
(-3.22 to -2.28)
PI-exp, Week 12; n=0, 33
NA [1] 
(NA to NA)
-2.23
(-2.85 to -1.34)
PI-naïve, Week 24; n=18, 44
-3.16
(-3.41 to -2.46)
-2.87
(-3.48 to -2.31)
PI-exp, Week 24; n=0, 35
NA [1] 
(NA to NA)
-2.28
(-3.04 to -1.21)
PI-naïve, Week 48; n=18, 44
-3.02
(-3.41 to -2.46)
-2.83
(-3.51 to -2.14)
PI-exp, Week 48; n=0, 33
NA [1] 
(NA to NA)
-2.14
(-3.04 to -0.92)
[1]
No participants were analyzed for this population at this time point.
30.Secondary Outcome
Title 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)
Hide Description Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 79
Measure Type: Number
Unit of Measure: participants
PI-naïve, Week 2; n=14, 39 13 35
PI-exp, Week 2; n=0, 32 NA [1]  22
PI-naïve, Week 12; n=19, 46 19 41
PI-exp, Week 12; n=0, 33 NA [1]  26
PI-naïve, Week 24; n=18, 44 18 41
PI-exp, Week 24; n=0, 35 NA [1]  29
PI-naïve, Week 48; n=18, 44 17 40
PI-exp, Week 48; n=0, 33 NA [1]  24
[1]
No participants were analyzed for this population at this time point.
31.Secondary Outcome
Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
Hide Description 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.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 89
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeter (cells/cu mm)
PI-naïve, Baseline; n= 19, 49
810
(460 to 1000)
370
(200 to 670)
PI-naïve, Week 2; n= 13, 41
820
(760 to 1120)
450
(300 to 781)
PI-naïve, Week 12; n= 19, 46
1040
(600 to 1440)
581
(310 to 890)
PI-naïve, Week 24; n= 18, 44
1260
(1050 to 1640)
609
(341 to 905)
PI-naïve, Week 48; n= 18, 42
1080
(570 to 1400)
670
(433 to 910)
PI-exp, Baseline; n= 0, 40
NA [1] 
(NA to NA)
440
(220 to 685)
PI-exp, Week 2; n= 0, 32
NA [1] 
(NA to NA)
605
(270 to 755)
PI-exp, Week 12; n= 0, 31
NA [1] 
(NA to NA)
720
(380 to 870)
PI-exp, Week 24; n= 0, 34
NA [1] 
(NA to NA)
620
(370 to 790)
PI-exp, Week 48; n= 0, 29
NA [1] 
(NA to NA)
540
(350 to 640)
[1]
No participants were analyzed for this population at this time point.
32.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
Hide Description 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.
Time Frame Baseline and Weeks 2, 12, 24, and 48
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Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 78
Median (Inter-Quartile Range)
Unit of Measure: cells/cu mm
PI-naïve, Week 2; n=13, 41
20
(-20 to 180)
60
(0 to 160)
PI-naïve, Week 12; n=19, 46
170
(50 to 490)
180
(60 to 269)
PI-naïve, Week 24; n=18, 44
350
(110 to 640)
184
(53 to 367)
PI-naïve, Week 48; n=17, 42
340
(-40 to 470)
217
(100 to 398)
PI-exp, Week 2; n=0, 32
NA [1] 
(NA to NA)
90
(2 to 190)
PI-exp, Week 12; n=0, 31
NA [1] 
(NA to NA)
200
(70 to 340)
PI-exp, Week 24; n=0, 34
NA [1] 
(NA to NA)
150
(10 to 260)
PI-exp, Week 48; n=0, 29
NA [1] 
(NA to NA)
180
(0 to 270)
[1]
No participants were analyzed for this population at this time point.
33.Secondary Outcome
Title Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
Hide Description 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.
Time Frame Baseline and Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 89
Median (Inter-Quartile Range)
Unit of Measure: Percentage of TLs that are CD4+ cells
PI-naïve, Baseline; n=19, 49
19
(18 to 27)
21
(14 to 29)
PI-naïve, Week 2; n=13, 41
24
(22 to 25)
23
(18 to 30)
PI-naïve, Week 12; n=19, 46
27
(24 to 33)
25
(17 to 33)
PI-naïve, Week 24; n=18, 44
31
(26 to 34)
28
(19 to 36)
PI-naïve, Week 48; n=18, 42
32
(27 to 34)
29
(24 to 36)
PI-exp, Baseline; n=0, 40
NA [1] 
(NA to NA)
24
(11 to 30)
PI-exp, Week 2; n=0, 32
NA [1] 
(NA to NA)
22
(14 to 33)
PI-exp, Week 12; n=0, 31
NA [1] 
(NA to NA)
23
(15 to 34)
PI-exp, Week 24; n=0, 34
NA [1] 
(NA to NA)
23
(17 to 34)
PI-exp, Week 48; n=0, 29
NA [1] 
(NA to NA)
24
(15 to 32)
[1]
No participants were analyzed for this population at this time point.
34.Secondary Outcome
Title Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
Hide Description 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.
Time Frame Baseline and Week 2, 12, 24, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 19 78
Median (Inter-Quartile Range)
Unit of Measure: Percentage of TLs that are CD4+ cells
PI-naïve, Week 2; n=13, 41
3
(0 to 5)
1
(-1 to 4)
PI-naïve, Week 12; n=19, 46
6
(2 to 7)
5
(1 to 7)
PI-naïve, Week 24; n=18, 44
7
(3 to 11)
8
(4 to 10)
PI-naïve, Week 48; n=17, 42
8
(4 to 11)
10
(5 to 14)
PI-exp, Week 2; n=0, 32
NA [1] 
(NA to NA)
2
(0 to 5)
PI-exp, Week 12; n=0, 31
NA [1] 
(NA to NA)
3
(2 to 7)
PI-exp, Week 24; n=0, 34
NA [1] 
(NA to NA)
5
(1 to 8)
PI-exp, Week 48; n=0, 29
NA [1] 
(NA to NA)
6
(2 to 10)
[1]
No participants were analyzed for this population at this time point.
35.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Hide Description 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.
Time Frame Week 48
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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.
Arm/Group Title ART-Naïve, FPV Treatment Group ART-Naïve, FPV/RTV Treatment Group PI Naïve, ART Experienced, FPV/RTV Treatment Group PI Experienced, ART Experienced, FPV/RTV Treatment Group
Hide Arm/Group Description:
Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
Overall Number of Participants Analyzed 3 1 3 8
Measure Type: Number
Unit of Measure: participants
Any HIV NRTI Mutation 3 0 0 1
HIV NRTI mutation M184V 3 0 0 1
Any HIV NNRTI Mutation 0 0 0 1
HIV NNRTI Mutation V179D/E 0 0 0 1
Any HIV Major PI Mutations 2 0 1 1
HIV Major PI Mutation M46M/I 0 0 1 0
HIV Major PI Mutation M46M/L 1 0 0 0
HIV Major PI Mutation I50I/V 1 0 1 1
HIV Major PI Mutation I54I/L 1 0 0 0
HIV Major PI Mutation I54I/M 0 0 0 1
HIV Major PI Mutation I54I/M/V 0 0 1 0
HIV Major PI Mutation Q58Q/E 1 0 0 0
HIV Major PI Mutation V82A/V 1 0 0 0
HIV Major PI Mutation V82F/I 0 0 0 1
HIV Major PI Mutation I84I/V 0 0 1 0
Any Minor HIV PI Mutations 2 0 1 1
Minor HIV PI Mutation L10L/F 0 0 1 0
Minor HIV PI Mutation K20K/R 1 0 0 0
Minor HIV PI Mutation L33L/F 1 0 1 0
Minor HIV PI Mutation K43K/T 0 0 0 1
Minor HIV PI Mutation F53F/L 1 0 0 0
Minor HIV PI Mutation F53L 1 0 0 0
Minor HIV PI Mutation I62I/V 0 0 1 0
Minor HIV PI Mutation A71I/V 0 0 1 0
Minor HIV PI Mutation I85I/V 0 0 1 1
36.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Hide Description 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.
Time Frame After Week 48 through Week 240
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Hide Analysis Population Description
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.
Arm/Group Title ART-Naïve, FPV Treatment Group ART-Naïve, FPV/RTV Treatment Group PI Naïve, ART Experienced, FPV/RTV Treatment Group PI Experienced, ART Experienced, FPV/RTV Treatment Group
Hide Arm/Group Description:
Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
Overall Number of Participants Analyzed 1 1 0 5
Measure Type: Number
Unit of Measure: Participants
Any HIV NRTI Mutation 1 1 2
HIV NRTI mutation M41L 0 0 1
HIV NRTI mutation M184I 0 1 0
HIV NRTI mutation M184V 1 0 2
HIV NRTI mutation T215S/Y 0 0 1
Any Major HIV NNRTI Mutation 0 0 1
HIV NNRTI Mutation K103N 0 0 1
Any Minor HIV NNRTI Mutation 0 0 0
HIV NNRTI Mutation V179D/E 0 0 0
Any HIV Major PI Mutations 1 0 1
HIV Major PI Mutation V32I 0 0 1
HIV Major PI Mutation M46L 1 0 0
HIV Major PI Mutation I47IV 0 0 1
HIV Major PI Mutation T74P 1 0 0
HIV Major PI Mutation I84I/V 0 0 0
Any Minor HIV PI Mutations 1 0 2
Minor HIV PI Mutation L10F 1 0 0
Minor HIV PI Mutation L33F 0 0 1
Minor HIV PI Mutation I62I/V 0 0 1
Minor HIV PI Mutation I85V 1 0 0
37.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Hide Description 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.
Time Frame Baseline through 48 Weeks
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Hide Analysis Population Description
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
Arm/Group Title ART-Naïve, FPV Treatment Group ART-Naïve, FPV/RTV Treatment Group PI Naïve, ART-experienced, FPV/RTV Treatment Group PI-experienced, ART-experienced FPV/RTV Treatment Group
Hide Arm/Group Description:
Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
Overall Number of Participants Analyzed 3 1 3 8
Measure Type: Number
Unit of Measure: participants
Any NRTI 3 0 0 2
Abacavir 1 0 0 0
Didanosine 3 0 0 1
Emtricitabine 3 0 0 1
Lamivudine 3 0 0 1
Any NNRTI 0 0 0 0
Any PI 2 0 1 1
Unboosted Fosamprenavir 2 NA [1]  NA [1]  NA [1] 
Ritonavir- boosted Fosamprenavir NA [2]  0 1 1
Ritonavir 2 0 0 0
[1]
These participants took RTV-boosted FPV.
[2]
These participants took unboosted FPV.
38.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Hide Description 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.
Time Frame Week 60 through Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title ART-Naïve, FPV Treatment Group ART-Naïve, FPV/RTV Treatment Group PI Naïve, ART-experienced, FPV/RTV Treatment Group PI-experienced, ART-experienced FPV/RTV Treatment Group
Hide Arm/Group Description:
Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
Overall Number of Participants Analyzed 1 1 0 5
Measure Type: Number
Unit of Measure: Participants
Any NRTI 1 1 3
Abacavir 0 0 1
Didanosine 0 1 3
Emtricitabine 1 1 3
Lamivudine 1 1 2
Zidovudine 0 0 1
Any NNRTI 0 0 1
Delaviridine 0 0 1
Efavirenz 0 0 1
Nevirapine 0 0 1
Any PI 1 1 3
Unboosted Fosamprenavir 1 NA [1]  NA [2] 
Ritonavir- boosted Fosamprenavir NA [3]  0 1
Nelfinavir 0 1 0
Tipranavir 0 0 1
[1]
These participants took RTV-boosted FPV.
[2]
These participants took RTV-boosted FPV
[3]
These participants took unboosted FPV.
39.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Weeks 2, 12, 24, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 17 59
Measure Type: Number
Unit of Measure: participants
Week 2, Total Population; n= 17, 59 15 49
Week 2, 2 to <6 years (yrs); n= 17, 16 15 15
Week 2, 6 to <12 yrs; n= 0, 25 NA [1]  22
Week 2, 12 to 18 yrs; n= 0, 18 NA [1]  12
Week 12, Total Population; n= 16, 55 15 45
Week 12, 2 to <6 yrs; n= 16, 16 15 14
Week 12, 6 to <12 yrs; n= 0, 24 NA [1]  20
Week 12, 12 to 18 yrs; n= 0, 15 NA [1]  11
Week 24, Total Population; n= 16, 54 16 43
Week 24, 2 to <6 yrs; n= 16, 14 16 11
Week 24, 6 to <12 yrs; n= 0, 24 NA [1]  23
Week 24, 12 to 18 yrs; n= 0, 16 NA [1]  9
Week 48, Total Population; n= 15, 53 13 42
Week 48, 2 to <6 yrs; n= 15, 14 13 13
Week 48, 6 to <12 yrs; n= 0, 23 NA [1]  20
Week 48, 12 to 18 yrs; n= 0, 16 NA [1]  9
[1]
No participants were analyzed for this population at this time point.
40.Secondary Outcome
Title Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events
Hide Description No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description:
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).
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-&lt;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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FPV Treatment Group FPV/RTV Treatment Group
Hide Arm/Group Description 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). 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.
All-Cause Mortality
FPV Treatment Group FPV/RTV Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FPV Treatment Group FPV/RTV Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   5/20 (25.00%)   13/89 (14.61%) 
Gastrointestinal disorders     
Dental caries  1  0/20 (0.00%)  1/89 (1.12%) 
General disorders     
Adverse drug reaction  1  0/20 (0.00%)  1/89 (1.12%) 
Pyrexia  1  0/20 (0.00%)  1/89 (1.12%) 
Immune system disorders     
Drug hypersensitivity  1  3/20 (15.00%)  6/89 (6.74%) 
Infections and infestations     
Pneumonia  1  1/20 (5.00%)  2/89 (2.25%) 
Respiratory tract infection  1  1/20 (5.00%)  1/89 (1.12%) 
Cellulitis  1  0/20 (0.00%)  1/89 (1.12%) 
Ear infection  1  0/20 (0.00%)  1/89 (1.12%) 
Gastroenteritis  1  1/20 (5.00%)  0/89 (0.00%) 
Hepatitis B  1  0/20 (0.00%)  1/89 (1.12%) 
Measles  1  0/20 (0.00%)  1/89 (1.12%) 
Pyelonephritis  1  0/20 (0.00%)  1/89 (1.12%) 
Urinary tract infection  1  0/20 (0.00%)  1/89 (1.12%) 
Investigations     
Aspartate aminotransferase increased  1  0/20 (0.00%)  1/89 (1.12%) 
Blood creatine phosphokinase increased  1  0/20 (0.00%)  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/20 (0.00%)  1/89 (1.12%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/20 (0.00%)  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FPV Treatment Group FPV/RTV Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   18/20 (90.00%)   74/89 (83.15%) 
Ear and labyrinth disorders     
Ear pain  1  0/20 (0.00%)  7/89 (7.87%) 
Eye disorders     
Conjunctivitis  1  0/20 (0.00%)  8/89 (8.99%) 
Gastrointestinal disorders     
Vomiting  1  12/20 (60.00%)  28/89 (31.46%) 
Diarrhea  1  2/20 (10.00%)  26/89 (29.21%) 
Nausea  1  1/20 (5.00%)  10/89 (11.24%) 
Abdominal pain  1  0/20 (0.00%)  7/89 (7.87%) 
Dental caries  1  0/20 (0.00%)  6/89 (6.74%) 
General disorders     
Pyrexia  1  1/20 (5.00%)  19/89 (21.35%) 
Infections and infestations     
Upper respiratory tract infection  1  3/20 (15.00%)  20/89 (22.47%) 
Nasopharyngitis  1  1/20 (5.00%)  16/89 (17.98%) 
Respiratory tract infection  1  12/20 (60.00%)  4/89 (4.49%) 
Rhinitis  1  2/20 (10.00%)  15/89 (16.85%) 
Bronchitis  1  3/20 (15.00%)  12/89 (13.48%) 
Ear infection  1  3/20 (15.00%)  11/89 (12.36%) 
Otitis media  1  0/20 (0.00%)  11/89 (12.36%) 
Pharyngitis  1  1/20 (5.00%)  8/89 (8.99%) 
Gasrtroenteritis  1  0/20 (0.00%)  7/89 (7.87%) 
Tonsillitis  1  1/20 (5.00%)  6/89 (6.74%) 
Tinea capitis  1  0/20 (0.00%)  6/89 (6.74%) 
Nervous system disorders     
Headache  1  0/20 (0.00%)  14/89 (15.73%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/20 (5.00%)  33/89 (37.08%) 
Rhinorrhoea  1  1/20 (5.00%)  10/89 (11.24%) 
Oropharyngeal pain  1  0/20 (0.00%)  9/89 (10.11%) 
Nasal congestion  1  0/20 (0.00%)  8/89 (8.99%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/20 (0.00%)  14/89 (15.73%) 
Eczema  1  1/20 (5.00%)  5/89 (5.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
Other Publications:
Voronin E, Fortuny C, Perez-Tamarit D, et al. Pharmacokinetics, safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2 to 18 year-old children (48-week data, Study APV29005, a prospective, open-label, multi-centre, 48-week cohort study). Presented at: AIDS 2012 - 19th International AIDS Conference; July 22-27, 2012; Washington, DC.
Ross L, Cotton M, Cassim H, et al. HIV-1 drug resistance and mutational profile in fosamprenavir-treated HIV-infected children aged 2 months to 18 years at start of therapy. Presented at: AIDS 2012 - 19th International AIDS Conference; July 22-27, 2012; Washington DC.
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00089583     History of Changes
Other Study ID Numbers: APV29005
First Submitted: August 6, 2004
First Posted: August 10, 2004
Results First Submitted: February 24, 2012
Results First Posted: June 21, 2012
Last Update Posted: March 7, 2017