Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00071760
First received: October 30, 2003
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: March 2, 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
Interventions: Drug: 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
59 unique participants (par.) received >=1 investigational product (IP) dose; however, 1 par. was not given a randomization number and therefore was not enrolled into the study. Thus, the number of par. enrolled in the protocol record=58. 5/59 par. receiving only single doses of IP are not included in the Intent-to-Treat Exposed Population (N=54).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Per protocol, the initial intention was to enroll par. to receive fosamprenavir; however, ultimately, no par. were enrolled into cohorts to receive repeat dosing of fosamprenavir without ritonavir boosting. The 59 par. who received >=1 IP dose were included in the Safety Population.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Participant Flow:   Overall Study
    FPV/RTV BID  
STARTED     54  
Ongoing     25  
COMPLETED     0  
NOT COMPLETED     54  
Adverse Event                 3  
Lost to Follow-up                 4  
Protocol Violation                 1  
Withdrawal by Subject                 3  
Insufficient Viral Load Response                 3  
Pulmonary Tuberculosis                 1  
Unavailability of RTV                 8  
Relocation                 1  
Investigator's Recommendation (Rec.)                 4  
Study Team Rec./Resistance                 1  
Ongoing                 25  



  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/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Baseline Measures
    FPV/RTV BID  
Number of Participants  
[units: participants]
  54  
Age  
[units: Months]
Mean ± Standard Deviation
  8.6  ± 6.43  
Gender  
[units: Participants]
 
Female     31  
Male     23  
Race/Ethnicity, Customized  
[units: participants]
 
Black     44  
White/Caucasian     2  
American Indian     8  



  Outcome Measures
  Hide All Outcome Measures

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. hours, hr.
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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  9     10  
Plasma Amprenavir (APV) AUC (0-tau[τ])  
[units: Hr per microgram/milliliter (hr*µg/mL)]
Geometric Mean ( 95% Confidence Interval )
   
45/10 mg/kg BID; n=9, 1     26.6  
  ( 15.2 to 46.8 )  
  64.51  
  ( NA to NA ) [1]
60/10 mg/kg BID; n=2, 2     54.2  
  ( NA to NA ) [2]
  26.22  
  ( NA to NA ) [2]
45/7 mg/kg BID; n=2, 10     35.08  
  ( NA to NA ) [2]
  27.5  
  ( 14.5 to 52.1 )  
60/7 mg/kg BID; n=0, 8     NA  
  ( NA to NA ) [3]
  48.4  
  ( 12.9 to 181.5 )  
[1] The 95% CI is not available because the number of participants analyzed is 1.
[2] The 95% CI is not available because the number of participants analyzed is 2.
[3] 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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  9     10  
Plasma APV Cmax  
[units: Micrograms per milliliter (µg/mL)]
Least Squares Mean ( 95% Confidence Interval )
   
45/10 mg/kg BID; n=9, 1     6.25  
  ( 3.82 to 10.2 )  
  21.82  
  ( NA to NA ) [1]
60/10 mg/kg BID; n=2, 2     10.44  
  ( NA to NA ) [2]
  7.47  
  ( NA to NA ) [2]
45/7 mg/kg BID; n=2, 10     8.20  
  ( NA to NA ) [2]
  5.84  
  ( 3.35 to 10.2 )  
60/7 mg/kg BID; n=0, 9     NA  
  ( NA to NA ) [3]
  10.4  
  ( 3.64 to 30.0 )  
[1] The 95% CI is not available because the number of participants analyzed is 1.
[2] The 95% CI is not available because the number of participants analyzed is 2.
[3] 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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  11     29  
Plasma APV Cτ  
[units: Micrograms per milliliter (µg/mL)]
Geometric Mean ( 95% Confidence Interval )
   
45/10 mg/kg BID; n=11, 15     0.86  
  ( 0.50 to 1.48 )  
  1.92  
  ( 1.42 to 2.58 )  
60/10 mg/kg BID; n=3, 5     0.60  
  ( NA to 127.50 ) [1]
  2.58  
  ( 1.29 to 5.17 )  
45/7 mg/kg BID; n=3, 29     0.44  
  ( 0.18 to 1.07 )  
  2.17  
  ( 1.69 to 2.80 )  
60/7 mg/kg BID; n=0, 12     NA  
  ( NA to NA ) [2]
  2.81  
  ( 1.69 to 4.67 )  
[1] Because of the small sample size, the lower limit of the confidence interval cannot be reliably calculated.
[2] 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 mL/Min/kg   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma APV CL/F Following Dosing Expressed in mL/Min/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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  9     10  
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg  
[units: Milliliters/minute/kilogram (mL/min/kg)]
Geometric Mean ( 95% Confidence Interval )
   
45/10 mg/kg BID; n=9, 1     22.9  
  ( 12.9 to 40.6 )  
  10.42  
  ( NA to NA ) [1]
60/10 mg/kg BID; n=2, 2     15.3  
  ( NA to NA ) [2]
  31.92  
  ( NA to NA ) [2]
45/7 mg/kg BID; n=2, 10     17.50  
  ( NA to NA ) [2]
  22.8  
  ( 12.0 to 43.1 )  
60/7 mg/kg BID; n=0, 8     NA  
  ( NA to NA ) [3]
  17.8  
  ( 4.75 to 66.7 )  
[1] The 95% CI is not available because the number of participants analyzed is 1.
[2] The 95% CI is not available because the number of participants analyzed is 2.
[3] No participants were analyzed at this dose in this age group.

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



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

Measure Type Primary
Measure Title Plasma APV CL/F Following Dosing Expressed in mL/Min
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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  9     10  
Plasma APV CL/F Following Dosing Expressed in mL/Min  
[units: mL/min]
Geometric Mean ( 95% Confidence Interval )
   
45/10 mg/kg BID; n=9, 1     135  
  ( 69.1 to 262 )  
  62.5  
  ( NA to NA ) [1]
60/10 mg/kg BID; n=2, 2     86.4  
  ( NA to NA ) [2]
  234.3  
  ( NA to NA ) [2]
45/7 mg/kg BID; n=2, 10     106.7  
  ( NA to NA ) [2]
  190  
  ( 93.2 to 386.2 )  
60/7 mg/kg BID; n=0, 8     NA  
  ( NA to NA ) [3]
  172  
  ( 46.3 to 638 )  
[1] The 95% CI is not available because the number of participants analyzed is 1.
[2] The 95% CI is not available because the number of participants analyzed is 2.
[3] No participants were analyzed at this dose in this age group.

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



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

Measure Type Primary
Measure Title Plasma Unbound APV Cτ
Measure Description Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or "free" APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state.
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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  7     16  
Plasma Unbound APV Cτ  
[units: µg/mL]
Mean ± Standard Deviation
   
45/10 mg/kg BID; n=7, 16     0.091  ± 0.083     0.087  ± 0.076  
60/10 mg/kg BID; n=1, 7     0.003  ± NA [1]   0.069  ± 0.052  
45/7 mg/kg BID; n=1, 16     0.027  ± NA [1]   0.150  ± 0.086  
60/7 mg/kg BID; n=0, 12     NA  ± NA [2]   0.290  ± 0.310  
[1] The standard deviation is not available because the number of participants analyzed is 1.
[2] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma Unbound APV Cτ



7.  Primary:   Plasma Unbound APV Percent Protein Binding (%Cτ)   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Plasma Unbound APV Percent Protein Binding (%Cτ)
Measure Description Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.
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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  7     16  
Plasma Unbound APV Percent Protein Binding (%Cτ)  
[units: Percentage of total APV Cτ unbound]
Mean ± Standard Deviation
   
45/10 mg/kg BID; n=7, 15     5.79  ± 2.05     6.56  ± 2.27  
60/10 mg/kg BID; n=1, 7     5.32  ± NA [1]   5.81  ± 1.68  
45/7 mg/kg BID; n=1, 16     7.55  ± NA [1]   8.23  ± 8.67  
60/7 mg/kg BID; n=0, 9     NA  ± NA [2]   9.20  ± 5.39  
[1] The standard deviation is not available because the number of participants analyzed is 1.
[2] No participants were analyzed at this dose in this age group.

No statistical analysis provided for Plasma Unbound APV Percent Protein Binding (%Cτ)



8.  Primary:   Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48   [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Primary
Measure Title Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48
Measure Description Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.
Time Frame Baseline (Day 1) and Weeks 4, 12, 24, 36, 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: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  49  
Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48  
[units: International units per liter (IU/L)]
Median ( Inter-Quartile Range )
 
ALT, Week 4; n=49     -7.0  
  ( -12.0 to -2.0 )  
ALT, Week 12; n=47     -4.0  
  ( -11.0 to 1.0 )  
ALT, Week 24; n=46     -7.5  
  ( -13.0 to 0.0 )  
ALT, Week 36; n=43     -5.0  
  ( -14.0 to 0.0 )  
ALT, Week 48; n=40     -4.0  
  ( -15.0 to 2.0 )  
AST, Week 4; n=49     -8.0  
  ( -18.0 to -3.0 )  
AST, Week 12; n=47     -9.0  
  ( -17.0 to 0.0 )  
AST, Week 24; n=46     -10.5  
  ( -18.0 to -1.0 )  
AST, Week 36; n=42     -11.5  
  ( -17.0 to -1.0 )  
AST, Week 48; n=39     -9.0  
  ( -22.0 to -1.0 )  

No statistical analysis provided for Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48



9.  Primary:   Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48   [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Primary
Measure Title Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48
Measure Description Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.
Time Frame Baseline (Day 1) and Weeks 4, 12, 24, 36, 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 were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  49  
Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48  
[units: Millimoles per liter (mmol/L)]
Median ( Inter-Quartile Range )
 
Cholesterol, Week 4; n=1     1.300  
  ( 1.300 to 1.300 )  
Cholesterol, Week 12; n=2     1.125  
  ( 0.400 to 1.850 )  
Cholesterol, Week 24; n=41     1.220  
  ( 0.880 to 2.230 )  
Cholesterol, Week 36; n=5     -0.140  
  ( -0.510 to 1.130 )  
Cholesterol, Week 48; n=35     1.460  
  ( 1.100 to 2.100 )  
Glucose, Week 4; n=49     -0.10  
  ( -0.60 to 0.30 )  
Glucose, Week 12; n=47     -0.10  
  ( -0.50 to 0.70 )  
Glucose, Week 24; n=46     -0.35  
  ( -1.00 to 0.30 )  
Glucose, Week 36; n=43     -0.20  
  ( -0.70 to 0.30 )  
Glucose, Week 48; n=40     -0.10  
  ( -0.55 to 0.30 )  
HDL, Week 4; n=1     0.400  
  ( 0.400 to 0.400 )  
HDL, Week 12; n=2     0.275  
  ( 0.150 to 0.400 )  
HDL, Week 24; n=41     0.250  
  ( 0.120 to 0.410 )  
HDL, Week 36; n=5     0.120  
  ( -0.300 to 0.200 )  
HDL, Week 48; n=35     0.270  
  ( 0.110 to 0.500 )  
LDL, Week 4; n=1     2.00  
  ( 2.00 to 2.00 )  
LDL, Week 12; n=2     0.82  
  ( 0.60 to 1.04 )  
LDL, Week 24; n=40     1.08  
  ( 0.53 to 1.79 )  
LDL, Week 36; n=5     0.65  
  ( 0.25 to 1.05 )  
LDL, Week 48; n=34     1.50  
  ( 1.20 to 1.65 )  
TG, Week 4; n=1     -2.360  
  ( -2.360 to -2.360 )  
TG, Week 12; n=2     0.070  
  ( -1.300 to 1.440 )  
TG, Week 24; n=41     -0.120  
  ( -0.730 to 0.650 )  
TG, Week 36; n=5     0.010  
  ( -0.390 to 0.140 )  
TG, Week 48; n=35     -0.340  
  ( -0.800 to 0.340 )  
Potassium, Week 4; n=49     -0.10  
  ( -0.40 to 0.30 )  
Potassium, Week 12; n=47     -0.20  
  ( -0.50 to 0.20 )  
Potassium, Week 24; n=46     -0.10  
  ( -0.40 to 0.30 )  
Potassium, Week 36; n=43     0  
  ( -0.60 to 0.40 )  
Potassium, Week 48; n=40     -0.25  
  ( -0.70 to -0.02 )  
Sodium, Week 4; n=49     0  
  ( -3.0 to 1.0 )  
Sodium, Week 12; n=47     0  
  ( -3.0 to 1.0 )  
Sodium, Week 24; n=46     0  
  ( -3.0 to 2.0 )  
Sodium, Week 36; n=43     -1.0  
  ( -3.0 to 1.0 )  
Sodium, Week 48; n=40     0  
  ( -2.5 to 3.0 )  

No statistical analysis provided for Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48



10.  Primary:   Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48   [ Time Frame: Baseline (Day 1) and Weeks 4, 12, 24, and 48 ]

Measure Type Primary
Measure Title Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 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 the indicated time point minus the value at Baseline.
Time Frame Baseline (Day 1) and Weeks 4, 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 were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  8  
Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48  
[units: Units per liter (U/L)]
Median ( Inter-Quartile Range )
 
Week 4; n=1     -6.0  
  ( -6.0 to -6.0 )  
Week 12; n=1     5.0  
  ( 5.0 to 5.0 )  
Week 24; n=8     -4.0  
  ( -9.0 to 3.5 )  
Week 48; n=8     -3.0  
  ( -14.5 to 4.5 )  

No statistical analysis provided for Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48



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

Measure Type Primary
Measure Title Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities
Measure Description TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater 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. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.
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 were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  51  
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities  
[units: participants]
 
ALT >5.0x upper limit of normal (ULN); n=51     3  
AST >5.0x ULN; n=51     0  
Cholesterol >7.77 millimoles/liter (mmol/L); n=49     0  
Lipase increased >3.0x ULN; n=10     0  
Hypoglycemia <2.22 mmol/L; n=51     0  
Hyperglycemia >13.88 mmol/L; n=51     0  
Hemoglobin <1.16 mmol/L; n=51     1  
Platelet count <50.000x10^9/L; n=51     0  
Albumin <20 grams (g)/L; n=51     0  
Alkaline Phosphatase >5.0x ULN; n=51     4  
Creatine Kinase >=10x ULN; n=51     3  
Hyperkalemia >6.5 mmol/L; n=51     0  
Hypokalemia <2.5 mmol/L; n=51     0  
Hypernatremia >=155 mmol/L; n=51     0  
Hyponatremia <125 mmol/L; n=51     0  
Total Neutrophils (Ns) <0.750x10^9/L; n=51     5  

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



12.  Primary:   Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)   [ Time Frame: Baseline (Day 1) until Week 48 ]

Measure Type Primary
Measure Title Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (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. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.
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. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  59  
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)  
[units: participants]
 
Bronchopneumonia     4  
Gastroenteritis     4  
Neutropenia     2  
Pneumonia     2  
Urinary tract infection     2  
Blood creatinine phosphokinase increased     2  
Hypertension     2  
Bronchiolitis     1  
Bronchitis     1  
Lower respiratory tract infection     1  
Meningitis     1  
Meningitis bacterial     1  
Pneumonia viral     1  
ALT increased     1  
Transaminase increased     1  
Thrombocytopenia     1  
Greenstick fracture     1  
Herbal toxicity     1  
Pneumonitis chemical     1  
Hypernatremia     1  
Kwashiorkor     1  
Inflammation     1  
Anogenital warts     1  
Febrile convulsion     1  

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)



13.  Primary:   Number of Participants Who Permanently Discontinued the Treatment Due to an AE   [ Time Frame: Baseline (Day 1) until Week 48 ]

Measure Type Primary
Measure Title Number of Participants Who Permanently Discontinued the Treatment Due to an 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 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. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  59  
Number of Participants Who Permanently Discontinued the Treatment Due to an AE  
[units: participants]
  1  

No statistical analysis provided for Number of Participants Who Permanently Discontinued the Treatment Due to an AE



14.  Secondary:   Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Secondary
Measure Title Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)
Measure Description Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. 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 4, 12, 24, 36, 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: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  54  
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)  
[units: participants]
 
Baseline     1  
Week 4     11  
Week 12     31  
Week 24     40  
Week 36     39  
Week 48     35  

No statistical analysis provided for Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)



15.  Secondary:   Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Secondary
Measure Title Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Measure Description Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.
Time Frame Baseline and Weeks 4, 12, 24, 36, 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 participants still enrolled in the study at a certain time point.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  54  
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)  
[units: log10 copies/mL]
Median ( Inter-Quartile Range )
 
Baseline, n=54     5.60  
  ( 5.00 to 6.15 )  
Week 4, n=49     3.11  
  ( 2.67 to 3.45 )  
Week 12, n=49     2.16  
  ( 1.69 to 3.08 )  
Week 24, n=47     1.69  
  ( 1.69 to 2.34 )  
Week 36, n=46     1.69  
  ( 1.69 to 2.08 )  
Week 48, n=42     1.69  
  ( 1.69 to 1.69 )  

No statistical analysis provided for Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)



16.  Secondary:   Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Measure Description Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.
Time Frame Baseline and Weeks 4, 12, 24, 36, 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 participants still enrolled in the study at a certain time point.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  49  
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)  
[units: log10 copies/mL]
Median ( Inter-Quartile Range )
 
Week 4, n=49     -2.34  
  ( -2.89 to -1.89 )  
Week 12, n=49     -3.13  
  ( -3.72 to -2.01 )  
Week 24, n=47     -3.62  
  ( -4.04 to -2.12 )  
Week 36, n=46     -3.55  
  ( -3.99 to -2.69 )  
Week 48, n=42     -3.66  
  ( -4.03 to -3.00 )  

No statistical analysis provided for Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)



17.  Secondary:   Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, 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 4, 12, 24, 36, and 48 (MSD=F Analysis)
Measure Description Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the 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 4, 12, 24, 36, 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.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  54  
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)  
[units: participants]
 
Week 4     44  
Week 12     46  
Week 24     44  
Week 36     41  
Week 48     37  

No statistical analysis provided for Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)



18.  Secondary:   Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Secondary
Measure Title Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, 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. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A 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 4, 12, 24, 36, 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.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  51  
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48  
[units: Percentage of cells]
Median ( Inter-Quartile Range )
 
Baseline, n=51     26  
  ( 18 to 34 )  
Week 4, n=51     28  
  ( 22 to 35 )  
Week 12, n=49     32  
  ( 24 to 36 )  
Week 24, n=48     32  
  ( 27 to 36 )  
Week 36, n=46     31  
  ( 26 to 38 )  
Week 48, n=42     29  
  ( 25 to 36 )  

No statistical analysis provided for Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48



19.  Secondary:   Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48   [ Time Frame: Baseline and Weeks 4, 12, 24, 36, and 48 ]

Measure Type Secondary
Measure Title Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, 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 indicated time points minus the value at Baseline.
Time Frame Baseline and Weeks 4, 12, 24, 36, 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. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  48  
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48  
[units: Percentage of cells]
Median ( Inter-Quartile Range )
 
Week 4, n=48     3.4  
  ( 0 to 6.3 )  
Week 12, n=46     4.5  
  ( 1 to 8 )  
Week 24, n=45     6.0  
  ( 1 to 11.1 )  
Week 36, n=43     6.1  
  ( 3 to 11.5 )  
Week 48, n=39     5.0  
  ( 1 to 8.9 )  

No statistical analysis provided for Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48



20.  Secondary:   Number of Participants With the Indicated Virological Outcome at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Virological Outcome 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 (withdrew consent, loss to follow-up, moved, etc.).
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.
ITT-E Population. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  54  
Number of Participants With the Indicated Virological Outcome at Week 48  
[units: participants]
 
Virological (V) success     35  
V failure (1)     5  
V failure (2)     2  
V failure (3)     2  
V failure (4)     3  
No V data at Week 48 (a)     2  
No V data at Week 48 (b)     5  

No statistical analysis provided for Number of Participants With the Indicated Virological Outcome at Week 48



21.  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 GSK Department of Clinical Pharmacology Modeling and Simulation conducted 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. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  11     22  
Plasma Ritonavir (RTV) AUC (0-τ)  
[units: hr*µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
7 mg/kg BID; n=2, 22     1.921  
  ( NA to NA ) [1]
  7.363  
  ( 4.769 to 11.369 )  
10 mg/kg BID; n=11, 2     12.952  
  ( 6.932 to 24.200 )  
  18.750  
  ( NA to NA ) [1]
[1] The 95% CI is not available because the number of participants analyzed is 2.

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



22.  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. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  12     23  
Plasma RTV Cmax  
[units: µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
7 mg/kg BID, n=2, 23     0.404  
  ( NA to NA ) [1]
  1.576  
  ( 0.991 to 2.506 )  
10 mg/kg BID, n=12, 2     2.388  
  ( 1.364 to 4.180 )  
  3.823  
  ( NA to NA ) [1]
[1] The 95% CI is not available because the number of participants analyzed is 2.

No statistical analysis provided for Plasma RTV Cmax



23.  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. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  15     33  
Plasma RTV Cτ  
[units: µg/mL]
Geometric Mean ( 95% Confidence Interval )
   
7 mg/kg BID, n=4, 33     0.0795  
  ( 0.0316 to 0.1996 )  
  0.2468  
  ( 0.1875 to 0.3249 )  
10 mg/kg BID, n=15, 19     0.1855  
  ( 0.1146 to 0.3003 )  
  0.4200  
  ( 0.2958 to 0.5962 )  

No statistical analysis provided for Plasma RTV Cτ



24.  Secondary:   Plasma RTV CL/F Expressed in mL/Min/kg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV CL/F Expressed in mL/Min/kg
Measure Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as 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. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  11     22  
Plasma RTV CL/F Expressed in mL/Min/kg  
[units: mL/min/kg]
Geometric Mean ( 95% Confidence Interval )
   
7 mg/kg BID, n=2, 22     58.668  
  ( NA to NA ) [1]
  14.960  
  ( 9.762 to 22.927 )  
10 mg/kg BID, n=11, 2     12.118  
  ( 6.435 to 22.818 )  
  8.938  
  ( NA to NA ) [1]
[1] The 95% CI is not available because the number of participants analyzed is 2.

No statistical analysis provided for Plasma RTV CL/F Expressed in mL/Min/kg



25.  Secondary:   Plasma RTV CL/F Expressed in mL/Min   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma RTV CL/F Expressed in mL/Min
Measure Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by 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. Only those participants contributing data were analyzed.

Reporting Groups
  Description
FPV/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  11     22  
Plasma RTV CL/F Expressed in mL/Min  
[units: mL/min]
Geometric Mean ( 95% Confidence Interval )
   
7 mg/kg BID, n=2, 22     335.2  
  ( NA to NA ) [1]
  134.1  
  ( 87.3 to 205.8 )  
10 mg/kg BID, n=11, 2     72.1  
  ( 38.7 to 134.3 )  
  57.9  
  ( NA to NA ) [1]
[1] The 95% CI is not available because the number of participants analyzed is 2.

No statistical analysis provided for Plasma RTV CL/F Expressed in mL/Min



26.  Secondary:   Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease   [ Time Frame: Baseline through 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 Baseline through 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/RTV Treatment Group ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
PI-naïve, ART-experienced FPV/RTV Treatment Group PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
PI-experienced, ART-experienced FPV/RTV Treatment Group PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.

Measured Values
    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]
  2     3     2  
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease  
[units: participants]
     
Any HIV NRTI Mutation     1     0     0  
HIV NRTI mutation M184V     1     0     0  
Any HIV NNRTI Mutation     0     0     1  
HIV NNRTI Mutation K101K/E     0     0     1  
Any HIV Major PI Mutations     0     0     0  
Any Minor HIV PI Mutations     2     0     1  
Minor HIV PI Mutation L10F     0     0     1  
Minor HIV PI Mutation L10I     1     0     0  
Minor HIV PI Mutation L33L/F     1     0     0  
Minor HIV PI Mutation L33F     0     0     1  

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



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

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 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 phenotype at both baseline and the indicated time of VF points were evaluable

Reporting Groups
  Description
ART-naïve FPV/RTV Treatment Group ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
ART-experienced, PI-naïve FPV/RTV Treatment Group PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
PI-experienced, ART-experienced FPV/RTV Treatment Group PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.

Measured Values
    ART-naïve FPV/RTV Treatment Group     ART-experienced, PI-naïve FPV/RTV Treatment Group     PI-experienced, ART-experienced FPV/RTV Treatment Group  
Number of Participants Analyzed  
[units: participants]
  2     3     2  
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)  
[units: participants]
     
Any NRTI     1     0     0  
Emtricitabine     1     0     0  
Lamivudine     1     0     0  
Any NNRTI     0     0     0  
Any PI     0     0     1  
Ritonavir-boosted Fosamprenavir     0     0     1  

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



28.  Secondary:   Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the 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 and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire
Measure Description A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant’s last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.
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/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  49  
Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire  
[units: participants]
 
Week 2, FPV=0 doses missed, n=49     45  
Week 12, FPV=0 doses missed, n=49     46  
Week 24, FPV=0 doses missed, n=46     42  
Week 48, FPV=0 doses missed, n=34     30  
Week 2, RTV=0 doses missed, n=49     45  
Week 12, RTV=0 doses missed, n=49     46  
Week 24, RTV=0 doses missed, n=46     42  
Week 48, RTV=0 doses missed, n=34     31  

No statistical analysis provided for Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire



29.  Secondary:   Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4   [ Time Frame: Weeks 2, 24, and 48/premature study discontinuation ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4
Measure Description P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G’s perception of the child’s assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.
Time Frame Weeks 2, 24, and 48/premature study discontinuation  
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

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  50  
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4  
[units: participants]
 
Week 2, color, dislike, n=50     8  
Week 2, color, neutral, n=50     20  
Week 2, color, like, n=50     22  
Week 24, color, dislike, n=44     8  
Week 24, color, neutral, n=44     12  
Week 24, color, like, n=44     24  
Week 48, color, dislike, n=35     12  
Week 48, color, neutral, n=35     8  
Week 48, color, like, n=35     15  
Week 2, texture, dislike, n=50     9  
Week 2, texture, neutral, n=50     17  
Week 2, texture, like, n=50     24  
Week 24, texture, dislike, n=44     10  
Week 24, texture, neutral, n=44     16  
Week 24, texture, like, n=44     18  
Week 48, texture, dislike, n=34     11  
Week 48, texture, neutral, n=34     8  
Week 48, texture, like, n=34     15  
Week 2, odor, dislike, n=50     8  
Week 2, odor, neutral, n=50     10  
Week 2, odor, like, n=50     32  
Week 24, odor, dislike, n=44     11  
Week 24, odor, neutral, n=44     10  
Week 24, odor, like, n=44     23  
Week 48, odor, dislike, n=35     10  
Week 48, odor, neutral, n=35     6  
Week 48, odor, like, n=35     19  
Week 2, general satisfaction, dislike, n=50     8  
Week 2, general satisfaction, neutral, n=50     11  
Week 2, general satisfaction, like, n=50     31  
Week 24, general satisfaction, dislike, n=44     10  
Week 24, general satisfaction, neutral, n=44     9  
Week 24, general satisfaction, like, n=44     25  
Week 48, general satisfaction, dislike, n=35     12  
Week 48, general satisfaction, neutral, n=35     5  
Week 48, general satisfaction, like, n=35     18  

No statistical analysis provided for Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4



30.  Secondary:   Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10   [ Time Frame: Weeks (W) 2, 24, and 48/premature study discontinuation ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10
Measure Description Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian’s perception of the child’s assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.
Time Frame Weeks (W) 2, 24, and 48/premature study discontinuation  
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

Reporting Groups
  Description
FPV/RTV BID Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.

Measured Values
    FPV/RTV BID  
Number of Participants Analyzed  
[units: participants]
  50  
Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10  
[units: participants]
 
Week 2, Item 5, takes all/most med. easily, n=50     21  
Week 2, Item 5, problem taking a few med., n=50     20  
Week 2, Item 5, problem taking most med., n=50     8  
Week 2, Item 5, impossible to take med., n=50     1  
Week 24, Item 5, takes all/most med. easily, n=43     22  
Week 24, Item 5, problem taking a few med., n=43     15  
Week 24, Item 5, problem taking most med., n=43     5  
Week 24, Item 5, impossible to take med., n=43     1  
Week 48, Item 5, takes all/most med. easily, n=35     26  
Week 48, Item 5, problem taking a few med., n=35     9  
Week 48, Item 5, problem taking most med., n=35     0  
Week 48, Item 5, impossible to take med., n=35     0  
Week 2, Item 6, dislike, n=50     21  
Week 2, Item 6, neutral, n=50     14  
Week 2, Item 6, like, n=50     15  
Week 24, Item 6, dislike, n=43     23  
Week 24, Item 6, neutral, n=43     8  
Week 24, Item 6, like, n=43     12  
Week 48, Item 6, dislike, n=35     17  
Week 48, Item 6, neutral, n=35     7  
Week 48, Item 6, like, n=35     11  
Week 2, Item 7, no problem taking FPV, n=50     13  
Week 2, Item 7, few problems taking FPV, n=50     18  
Week 2, Item 7, problem taking most of time, n=50     15  
Week 2, Item 7, impossible to take, n=50     4  
Week 24, Item 7, no problem taking FPV, n=43     23  
Week 24, Item 7, few problems taking FPV, n=43     8  
Week 24, Item 7, problem taking most of time, n=43     12  
Week 24, Item 7, impossible to take, n=43     0  
Week 48, Item 7, no problem taking FPV, n=35     17  
Week 48, Item 7, few problems taking FPV, n=35     11  
Week 48, Item 7, problem taking most of time, n=35     4  
Week 48, Item 7, impossible to take, n=35     3  
Week 2, Item 8, swallows with no problem, n=50     19  
Week 2, Item 8, swallows with struggle, n=50     21  
Week 2, Item 8, spits out suspension, n=50     5  
Week 2, Item 8, vomits the suspension, n=50     5  
Week 24, Item 8, swallows with no problem, n=43     22  
Week 24, Item 8, swallows with struggle, n=43     16  
Week 24, Item 8, spits out suspension, n=43     5  
Week 24, Item 8, vomits the suspension, n=43     0  
Week 48, Item 8, swallows with no problem, n=35     22  
Week 48, Item 8, swallows with struggle, n=35     10  
Week 48, Item 8, spits out suspension, n=35     2  
Week 48, Item 8, vomits the suspension, n=35     1  
W2, I9, take more willingly than other med., n=50     6  
Week 2, Item 9, about the same, n=50     28  
W2, I9, not as willing to take as other med., n=50     16  
W24, I9, take more willingly than other med., n=42     4  
Week 24, Item 9, about the same, n=42     31  
W24, I9, not as willing to take as other med, n=42     7  
W48, I9, take more willingly than other med., n=35     10  
Week 48, Item 9, about the same, n=35     23  
W48, I9, not as willing to take as other med, n=35     2  
Week 2, Item 10, dislike, n=50     20  
Week 2, Item 10, neutral, n=50     14  
Week 2, Item 10, like, n=50     16  
Week 24, Item 10, dislike, n=44     20  
Week 24, Item 10, neutral, n=44     9  
Week 24, Item 10, like, n=44     15  
Week 48, Item 10, dislike, n=35     13  
Week 48, Item 10, neutral, n=35     11  
Week 48, Item 10, like, n=35     11  

No statistical analysis provided for Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10



31.  Secondary:   Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or 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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  0     0  
Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events          

No statistical analysis provided for Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events



32.  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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV AUC (0-τ)          

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



33.  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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV Cmax and Cτ          

No statistical analysis provided for Plasma FPV Cmax and Cτ



34.  Secondary:   Plasma FPV CL/F Expressed in mL/Min/kg   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV CL/F Expressed in mL/Min/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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV CL/F Expressed in mL/Min/kg          

No statistical analysis provided for Plasma FPV CL/F Expressed in mL/Min/kg



35.  Secondary:   Plasma FPV CL/F Expressed in mL/Min   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Plasma FPV CL/F Expressed in mL/Min
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/RTV BID: 4 Weeks to <6 Months Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
FPV/RTV BID: 6 Months to <2 Years Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Measured Values
    FPV/RTV BID: 4 Weeks to <6 Months     FPV/RTV BID: 6 Months to <2 Years  
Number of Participants Analyzed  
[units: participants]
  0     0  
Plasma FPV CL/F Expressed in mL/Min          

No statistical analysis provided for Plasma FPV CL/F Expressed in mL/Min




  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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