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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00089583
First received: August 6, 2004
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: February 24, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus I
Interventions: Drug: LEXIVA (GW433908)
Drug: Ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.

Participant Flow:   Overall Study
    FPV Treatment Group     FPV/RTV Treatment Group  
STARTED     20     89  
COMPLETED     13     51  
NOT COMPLETED     7     38  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
Total Total of all reporting groups

Baseline Measures
    FPV Treatment Group     FPV/RTV Treatment Group     Total  
Number of Participants  
[units: participants]
  20     89     109  
Age  
[units: Years]
Mean ± Standard Deviation
  2.9  ± 1.07     10.0  ± 4.49     8.7  ± 4.93  
Gender  
[units: Participants]
     
Female     15     43     58  
Male     5     46     51  
Race/Ethnicity, Customized  
[units: 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]
[units: 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] 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.



  Outcome Measures
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1.  Primary:   Plasma Amprenavir (APV) AUC (0-tau[τ])   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma Amprenavir (APV) AUC (0-tau[τ])
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma Amprenavir (APV) AUC (0-tau[τ])  
[units: hr*µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6 yrs, 30 mg/kg BID; n=9, 0     22.3  
  ( 15.3 to 32.6 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 40 mg/kg BID; n=7, 0     24.1  
  ( 15.2 to 38.0 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  55.3  
  ( 37.9 to 80.7 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9     NA  
  ( NA to NA ) [1]
  32.3  
  ( 23.0 to 45.3 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [1]
  48.4  
  ( 38.1 to 61.4 )  
6 to <12 yrs, 700/100 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  37.6  
  ( 22.2 to 63.8 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  21.8  
  ( 18.0 to 26.3 )  
12 to 18 yrs, 18/3 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  41.7  
  ( 16.2 to 108 )  
12 to 18 yrs, 700/100 mg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  35.3  
  ( 28.2 to 44.1 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma Amprenavir (APV) AUC (0-tau[τ])



2.  Primary:   Plasma APV Cmax   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV Cmax
Measure Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma APV Cmax  
[units: Micrograms per milliliter (µg/mL)]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6 yrs, 30 mg/kg BID; n=9, 0     7.15  
  ( 5.05 to 10.10 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 40 mg/kg BID; n=7, 0     6.52  
  ( 4.47 to 9.51 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  8.66  
  ( 6.08 to 12.30 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10     NA  
  ( NA to NA ) [1]
  4.34  
  ( 3.16 to 5.96 )  
6 to <12.yrs, 18/3 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [1]
  6.40  
  ( 5.02 to 8.15 )  
6 to <12 yrs, 700/100 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  5.85  
  ( 3.94 to 8.70 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  3.92  
  ( 2.44 to 6.29 )  
12 to 18 yrs, 18/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  4.91  
  ( 2.69 to 8.97 )  
12 to 18 yrs, 700/100 mg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  4.93  
  ( 3.83 to 6.34 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma APV Cmax



3.  Primary:   Plasma APV Cτ   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV Cτ
Measure Description The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     40  
Plasma APV Cτ  
[units: Micrograms per milliliter (µg/mL)]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6 yrs, 30 mg/kg BID; n=19, 0     0.55  
  ( 0.41 to 0.75 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 40 mg/kg BID; n=10, 0     0.70  
  ( 0.41 to 1.19 )  
  NA  
  ( NA to NA ) [1]
2 to <6 yrs, 23/3 mg/kg BID; n=0, 16     NA  
  ( NA to NA ) [1]
  3.39  
  ( 2.51 to 4.57 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  2.24  
  ( 1.70 to 2.93 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 23     NA  
  ( NA to NA ) [1]
  2.42  
  ( 1.90 to 3.07 )  
6 to <12 yrs, 700/100 mg BID; n=0, 7     NA  
  ( NA to NA ) [1]
  1.81  
  ( 0.80 to 4.08 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 6     NA  
  ( NA to NA ) [1]
  1.45  
  ( 0.56 to 3.74 )  
12 to 18 yrs, 18/3 mg/kg BID; n=0, 10     NA  
  ( NA to NA ) [1]
  1.80  
  ( 1.22 to 2.67 )  
12 to 18 yrs, 700/100 mg BID; n=0, 40     NA  
  ( NA to NA ) [1]
  2.01  
  ( 1.74 to 2.32 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma APV Cτ



4.  Primary:   Plasma APV CL/F Following Dosing Expressed in mg/kg   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV CL/F Following Dosing Expressed in mg/kg
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma APV CL/F Following Dosing Expressed in mg/kg  
[units: Milliliters/minute/kilogram (mL/min/kg)]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6yrs, 30 mg/kg BID; n=9, 0     19.3  
  ( 13.2 to 28.2 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 40 mg/kg BID; n=7, 0     23.4  
  ( 14.9 to 36.8 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  6.06  
  ( 4.12 to 8.91 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9     NA  
  ( NA to NA ) [1]
  6.48  
  ( 4.68 to 8.98 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [1]
  5.27  
  ( 4.16 to 6.68 )  
6 to <12 yrs, 700/100 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  5.94  
  ( 2.59 to 13.9 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  10.1  
  ( 8.35 to 12.3 )  
12 to 18 yrs, 18/3 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  6.00  
  ( 2.37 to 15.2 )  
12 to 18 yrs, 700/100 mg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  5.33  
  ( 4.26 to 6.68 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma APV CL/F Following Dosing Expressed in mg/kg



5.  Primary:   Plasma APV CL/F Following Dosing Expressed in mg   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV CL/F Following Dosing Expressed in mg
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma APV CL/F Following Dosing Expressed in mg  
[units: Milliliters per minute (mL/min)]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6yrs, 30 mg/kg BID; n=9, 0     269  
  ( 193 to 376 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 40 mg/kg BID; n=7, 0     330  
  ( 203 to 538 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  91  
  ( 60 to 139 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 9     NA  
  ( NA to NA ) [1]
  195  
  ( 136 to 279 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [1]
  149  
  ( 104 to 214 )  
6 to <12 yrs, 700/100 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  266  
  ( 157 to 452 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  392  
  ( 355 to 432 )  
12 to 18 yrs, 18/3 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  198  
  ( 47 to 838 )  
12 to 18 yrs, 700/100 mg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  284  
  ( 227 to 354 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma APV CL/F Following Dosing Expressed in mg



6.  Primary:   Plasma APV Tmax   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV Tmax
Measure Description The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma APV Tmax  
[units: hours]
Median ( Full Range )
   
2 to <6yrs, 30 mg/kg BID; n=9, 0     1.17  
  ( 1.00 to 3.75 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 40 mg/kg BID; n=7, 0     1.00  
  ( 0.75 to 2.00 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  1.25  
  ( 1.00 to 4.00 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 10     NA  
  ( NA to NA ) [1]
  2.00  
  ( 1.00 to 6.00 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [1]
  1.96  
  ( 0.50 to 4.00 )  
6 to <12 yrs, 700/100 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  3.92  
  ( 1.00 to 4.02 )  
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  1.00  
  ( 1.00 to 2.00 )  
12 to 18 yrs, 18/3 mg BID; n=0, 3     NA  
  ( NA to NA ) [1]
  1.50  
  ( 0.00 to 2.00 )  
12 to 18 yrs, 700/100 mg BID; n=0, 13     NA  
  ( NA to NA ) [1]
  2.00  
  ( 0.92 to 7.97 )  
[1] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma APV Tmax



7.  Primary:   Plasma APV t1/2   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV t1/2
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  9     14  
Plasma APV t1/2  
[units: hours]
Geometric Mean ( 95% Confidence Interval )
   
2 to <6yrs, 30 mg/kg BID; n=9, 0     3.03  
  ( 2.09 to 4.41 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 40 mg/kg BID; n=5, 0     3.18  
  ( 2.14 to 4.73 )  
  NA  
  ( NA to NA ) [1]
2 to <6yrs, 23/3 mg/kg BID; n=0, 14     NA  
  ( NA to NA ) [1]
  5.21  
  ( 4.47 to 6.08 )  
6 to <12 yrs, 15/3 mg/kg BID; n=0, 7     NA  
  ( NA to NA ) [1]
  10.5  
  ( 8.36 to 13.1 )  
6 to <12 yrs, 18/3 mg/kg BID; n=0, 10     NA  
  ( NA to NA ) [1]
  8.41  
  ( 5.90 to 12.0 )  
6 to <12 yrs, 700/100 mg BID; n=0, 2     NA  
  ( NA to NA ) [1]
  7.43  
  ( NA to NA ) [2]
12 to 18 yrs, 15/3 mg/kg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  6.12  
  ( 3.67 to 10.2 )  
12 to 18 yrs, 18/3 mg BID; n=0, 4     NA  
  ( NA to NA ) [1]
  8.76  
  ( 2.79 to 27.5 )  
12 to 18 yrs, 700/100 mg BID; n=0, 11     NA  
  ( NA to NA ) [1]
  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.

No statistical analysis provided for Plasma APV t1/2



8.  Primary:   Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  20     89  
Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)  
[units: participants]
  0     4  

No statistical analysis provided for Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)



9.  Primary:   Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Primary
Measure Title Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  18     69  
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48  
[units: Millimoles per liter (mmol/L)]
Median ( Inter-Quartile Range )
   
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 )  

No statistical analysis provided for Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48



10.  Primary:   Change From Baseline in Serum Lipase at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Primary
Measure Title Change From Baseline in Serum Lipase at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  18     69  
Change From Baseline in Serum Lipase at Week 48  
[units: Units per liter (U/L)]
Median ( Inter-Quartile Range )
  -2.0  
  ( -5.0 to 0.0 )  
  -1.0  
  ( -7.0 to 4.0 )  

No statistical analysis provided for Change From Baseline in Serum Lipase at Week 48



11.  Primary:   Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Primary
Measure Title Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  18     70  
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48  
[units: International units per liter (IU/L)]
Median ( Inter-Quartile Range )
   
ALT     -3  
  ( -14 to 19 )  
  -7  
  ( -16 to -1 )  
AST     -6  
  ( -19 to 10 )  
  -9  
  ( -17 to -4 )  

No statistical analysis provided for Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48



12.  Primary:   Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities   [ Time Frame: Baseline (Day 1) until Week 48 ]

Measure Type Primary
Measure Title Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  20     87  
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities  
[units: 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  

No statistical analysis provided for Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities



13.  Secondary:   Plasma Ritonavir (RTV) AUC (0-τ)   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma Ritonavir (RTV) AUC (0-τ)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     15  
Plasma Ritonavir (RTV) AUC (0-τ)  
[units: hr*µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
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  
  ( NA to NA ) [1]
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.

No statistical analysis provided for Plasma Ritonavir (RTV) AUC (0-τ)



14.  Secondary:   Plasma RTV Cmax   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV Cmax
Measure Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     16  
Plasma RTV Cmax  
[units: µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
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 )  

No statistical analysis provided for Plasma RTV Cmax



15.  Secondary:   Plasma RTV Cτ   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV Cτ
Measure Description The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     41  
Plasma RTV Cτ  
[units: µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
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 )  

No statistical analysis provided for Plasma RTV Cτ



16.  Secondary:   Plasma RTV CL/F Following Dosing Expressed in mg/kg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV CL/F Following Dosing Expressed in mg/kg
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     15  
Plasma RTV CL/F Following Dosing Expressed in mg/kg  
[units: mL/min/kg]
Geometric Mean ( 95% Confidence Interval )
   
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  
  ( NA to NA ) [1]
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.

No statistical analysis provided for Plasma RTV CL/F Following Dosing Expressed in mg/kg



17.  Secondary:   Plasma RTV CL/F Following Dosing Expressed in mg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV CL/F Following Dosing Expressed in mg
Measure Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     15  
Plasma RTV CL/F Following Dosing Expressed in mg  
[units: mL/min]
Geometric Mean ( 95% Confidence Interval )
   
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  
  ( NA to NA ) [1]
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.

No statistical analysis provided for Plasma RTV CL/F Following Dosing Expressed in mg



18.  Secondary:   Plasma RTV Tmax   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV Tmax
Measure Description The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     15  
Plasma RTV Tmax  
[units: hours]
Median ( Full Range )
   
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 )  

No statistical analysis provided for Plasma RTV Tmax



19.  Secondary:   Plasma RTV t1/2   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV t1/2
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     14  
Plasma RTV t1/2  
[units: hours]
Geometric Mean ( 95% Confidence Interval )
   
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  
  ( NA to NA ) [1]
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.

No statistical analysis provided for Plasma RTV t1/2



20.  Secondary:   Plasma FPV AUC (0-τ)   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV AUC (0-τ)
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV AUC (0-τ)          

No statistical analysis provided for Plasma FPV AUC (0-τ)



21.  Secondary:   Plasma FPV Cmax and Cτ   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV Cmax and Cτ
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV Cmax and Cτ          

No statistical analysis provided for Plasma FPV Cmax and Cτ



22.  Secondary:   Plasma FPV CL/F Following Dosing Expressed in mg/kg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV CL/F Following Dosing Expressed in mg/kg
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV CL/F Following Dosing Expressed in mg/kg          

No statistical analysis provided for Plasma FPV CL/F Following Dosing Expressed in mg/kg



23.  Secondary:   Plasma FPV CL/F Following Dosing Expressed in mg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV CL/F Following Dosing Expressed in mg
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV CL/F Following Dosing Expressed in mg          

No statistical analysis provided for Plasma FPV CL/F Following Dosing Expressed in mg



24.  Secondary:   Plasma FPV Tmax   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV Tmax
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV Tmax          

No statistical analysis provided for Plasma FPV Tmax



25.  Secondary:   Plasma FPV t1/2   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV t1/2
Measure Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV t1/2          

No statistical analysis provided for Plasma FPV t1/2



26.  Secondary:   Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  20     89  
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48  
[units: 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.

No statistical analysis provided for Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48



27.  Secondary:   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)   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure 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)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  20     89  
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)  
[units: 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.

No statistical analysis provided for 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)



28.  Secondary:   Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure Title Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  20     88  
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)  
[units: log10 copies/mL]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  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  
  ( NA to NA ) [1]
  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  
  ( NA to NA ) [1]
  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  
  ( NA to NA ) [1]
  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  
  ( NA to NA ) [1]
  1.69  
  ( 1.69 to 3.51 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)



29.  Secondary:   Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure Title Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     79  
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)  
[units: log10/copies]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  -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  
  ( NA to NA ) [1]
  -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  
  ( NA to NA ) [1]
  -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  
  ( NA to NA ) [1]
  -2.14  
  ( -3.04 to -0.92 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)



30.  Secondary:   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)   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure 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)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     79  
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)  
[units: 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.

No statistical analysis provided for 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)



31.  Secondary:   Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     89  
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48  
[units: Cells per cubic millimeter (cells/cu mm)]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  440  
  ( 220 to 685 )  
PI-exp, Week 2; n= 0, 32     NA  
  ( NA to NA ) [1]
  605  
  ( 270 to 755 )  
PI-exp, Week 12; n= 0, 31     NA  
  ( NA to NA ) [1]
  720  
  ( 380 to 870 )  
PI-exp, Week 24; n= 0, 34     NA  
  ( NA to NA ) [1]
  620  
  ( 370 to 790 )  
PI-exp, Week 48; n= 0, 29     NA  
  ( NA to NA ) [1]
  540  
  ( 350 to 640 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48



32.  Secondary:   Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     78  
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48  
[units: cells/cu mm]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  90  
  ( 2 to 190 )  
PI-exp, Week 12; n=0, 31     NA  
  ( NA to NA ) [1]
  200  
  ( 70 to 340 )  
PI-exp, Week 24; n=0, 34     NA  
  ( NA to NA ) [1]
  150  
  ( 10 to 260 )  
PI-exp, Week 48; n=0, 29     NA  
  ( NA to NA ) [1]
  180  
  ( 0 to 270 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48



33.  Secondary:   Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48   [ Time Frame: Baseline and Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure Title Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     89  
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48  
[units: Percentage of TLs that are CD4+ cells]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  24  
  ( 11 to 30 )  
PI-exp, Week 2; n=0, 32     NA  
  ( NA to NA ) [1]
  22  
  ( 14 to 33 )  
PI-exp, Week 12; n=0, 31     NA  
  ( NA to NA ) [1]
  23  
  ( 15 to 34 )  
PI-exp, Week 24; n=0, 34     NA  
  ( NA to NA ) [1]
  23  
  ( 17 to 34 )  
PI-exp, Week 48; n=0, 29     NA  
  ( NA to NA ) [1]
  24  
  ( 15 to 32 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48



34.  Secondary:   Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48   [ Time Frame: Baseline and Week 2, 12, 24, 48 ]

Measure Type Secondary
Measure Title Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  19     78  
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48  
[units: Percentage of TLs that are CD4+ cells]
Median ( Inter-Quartile Range )
   
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  
  ( NA to NA ) [1]
  2  
  ( 0 to 5 )  
PI-exp, Week 12; n=0, 31     NA  
  ( NA to NA ) [1]
  3  
  ( 2 to 7 )  
PI-exp, Week 24; n=0, 34     NA  
  ( NA to NA ) [1]
  5  
  ( 1 to 8 )  
PI-exp, Week 48; n=0, 29     NA  
  ( NA to NA ) [1]
  6  
  ( 2 to 10 )  
[1] No participants were analyzed for this population at this time point.

No statistical analysis provided for Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48



35.  Secondary:   Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ART-Naïve, FPV Treatment Group 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)
ART-Naïve, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Naïve, ART Experienced, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Experienced, ART Experienced, FPV/RTV Treatment Group HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  3     1     3     8  
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease  
[units: 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  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease



36.  Secondary:   Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease   [ Time Frame: After Week 48 through Week 240 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ART-Naïve, FPV Treatment Group 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)
ART-Naïve, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Naïve, ART Experienced, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Experienced, ART Experienced, FPV/RTV Treatment Group HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  1     1     0     5  
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease  
[units: 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  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease



37.  Secondary:   Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)   [ Time Frame: Baseline through 48 Weeks ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
ART-Naïve, FPV Treatment Group 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)
ART-Naïve, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Naïve, ART-experienced, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI-experienced, ART-experienced FPV/RTV Treatment Group HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  3     1     3     8  
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)  
[units: 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.

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)



38.  Secondary:   Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)   [ Time Frame: Week 60 through Week 240 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
ART-Naïve, FPV Treatment Group 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)
ART-Naïve, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI Naïve, ART-experienced, FPV/RTV Treatment Group HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
PI-experienced, ART-experienced FPV/RTV Treatment Group HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  1     1     0     5  
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)  
[units: 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.

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)



39.  Secondary:   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   [ Time Frame: Weeks 2, 12, 24, and 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  17     59  
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  
[units: 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.

No statistical analysis provided for 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



40.  Secondary:   Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events
Measure Description No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups
  Description
FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&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.

Measured Values
    FPV Treatment Group     FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  0     0  
Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events          

No statistical analysis provided for Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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