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

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ClinicalTrials.gov Identifier: NCT00071760
Recruitment Status : Active, not recruiting
First Posted : October 31, 2003
Results First Posted : August 23, 2012
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: GW433908
Drug: ritonavir
Enrollment 75
Recruitment Details 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 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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 54
Ongoing 25
Completed 0
Not Completed 54
Reason Not Completed
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
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 54 participants
8.6  (6.43)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
31
  57.4%
Male
23
  42.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Black 44
White/Caucasian 2
American Indian 8
1.Primary Outcome
Title Plasma Amprenavir (APV) AUC (0-tau[τ])
Hide Description Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where "τ" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hr per microgram/milliliter (hr*µg/mL)
45/10 mg/kg BID; n=9, 1
26.6
(15.2 to 46.8)
64.51 [1] 
(NA to NA)
60/10 mg/kg BID; n=2, 2
54.2 [2] 
(NA to NA)
26.22 [2] 
(NA to NA)
45/7 mg/kg BID; n=2, 10
35.08 [2] 
(NA to NA)
27.5
(14.5 to 52.1)
60/7 mg/kg BID; n=0, 8
NA [3] 
(NA to NA)
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.
2.Primary Outcome
Title Plasma APV Cmax
Hide Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Micrograms per milliliter (µg/mL)
45/10 mg/kg BID; n=9, 1
6.25
(3.82 to 10.2)
21.82 [1] 
(NA to NA)
60/10 mg/kg BID; n=2, 2
10.44 [2] 
(NA to NA)
7.47 [2] 
(NA to NA)
45/7 mg/kg BID; n=2, 10
8.20 [2] 
(NA to NA)
5.84
(3.35 to 10.2)
60/7 mg/kg BID; n=0, 9
NA [3] 
(NA to NA)
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.
3.Primary Outcome
Title Plasma APV Cτ
Hide Description The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: Micrograms per milliliter (µg/mL)
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 [1] 
(NA to 127.50)
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 [2] 
(NA to NA)
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.
4.Primary Outcome
Title Plasma APV CL/F Following Dosing Expressed in mL/Min/kg
Hide Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters/minute/kilogram (mL/min/kg)
45/10 mg/kg BID; n=9, 1
22.9
(12.9 to 40.6)
10.42 [1] 
(NA to NA)
60/10 mg/kg BID; n=2, 2
15.3 [2] 
(NA to NA)
31.92 [2] 
(NA to NA)
45/7 mg/kg BID; n=2, 10
17.50 [2] 
(NA to NA)
22.8
(12.0 to 43.1)
60/7 mg/kg BID; n=0, 8
NA [3] 
(NA to NA)
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.
5.Primary Outcome
Title Plasma APV CL/F Following Dosing Expressed in mL/Min
Hide Description Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min
45/10 mg/kg BID; n=9, 1
135
(69.1 to 262)
62.5 [1] 
(NA to NA)
60/10 mg/kg BID; n=2, 2
86.4 [2] 
(NA to NA)
234.3 [2] 
(NA to NA)
45/7 mg/kg BID; n=2, 10
106.7 [2] 
(NA to NA)
190
(93.2 to 386.2)
60/7 mg/kg BID; n=0, 8
NA [3] 
(NA to NA)
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.
6.Primary Outcome
Title Plasma Unbound APV Cτ
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: µg/mL
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 [1]   (NA) 0.069  (0.052)
45/7 mg/kg BID; n=1, 16 0.027 [1]   (NA) 0.150  (0.086)
60/7 mg/kg BID; n=0, 12 NA [2]   (NA) 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.
7.Primary Outcome
Title Plasma Unbound APV Percent Protein Binding (%Cτ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: Percentage of total APV Cτ unbound
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 [1]   (NA) 5.81  (1.68)
45/7 mg/kg BID; n=1, 16 7.55 [1]   (NA) 8.23  (8.67)
60/7 mg/kg BID; n=0, 9 NA [2]   (NA) 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.
8.Primary Outcome
Title Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Median (Inter-Quartile Range)
Unit of Measure: International units per liter (IU/L)
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)
9.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Median (Inter-Quartile Range)
Unit of Measure: Millimoles per liter (mmol/L)
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)
10.Primary Outcome
Title Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48
Hide Description Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.
Time Frame Baseline (Day 1) and Weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: Units per liter (U/L)
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)
11.Primary Outcome
Title Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: 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
12.Primary Outcome
Title Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: 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
13.Primary Outcome
Title Number of Participants Who Permanently Discontinued the Treatment Due to an AE
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Baseline (Day 1) until Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
1
14.Secondary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
Baseline 1
Week 4 11
Week 12 31
Week 24 40
Week 36 39
Week 48 35
15.Secondary Outcome
Title Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
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)
16.Secondary Outcome
Title Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
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)
17.Secondary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
Week 4 44
Week 12 46
Week 24 44
Week 36 41
Week 48 37
18.Secondary Outcome
Title Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48
Hide Description Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Median (Inter-Quartile Range)
Unit of Measure: Percentage of cells
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)
19.Secondary Outcome
Title Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48
Hide Description Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.
Time Frame Baseline and Weeks 4, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 48
Median (Inter-Quartile Range)
Unit of Measure: Percentage of cells
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)
20.Secondary Outcome
Title Number of Participants With the Indicated Virological Outcome at Week 48
Hide Description Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: 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
21.Secondary Outcome
Title Plasma Ritonavir (RTV) AUC (0-τ)
Hide 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
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Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*µg/mL
7 mg/kg BID; n=2, 22
1.921 [1] 
(NA to NA)
7.363
(4.769 to 11.369)
10 mg/kg BID; n=11, 2
12.952
(6.932 to 24.200)
18.750 [1] 
(NA to NA)
[1]
The 95% CI is not available because the number of participants analyzed is 2.
22.Secondary Outcome
Title Plasma RTV Cmax
Hide Description The maximum concentration at steady state (Cmax) was measured.
Time Frame Week 48
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Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 12 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
7 mg/kg BID, n=2, 23
0.404 [1] 
(NA to NA)
1.576
(0.991 to 2.506)
10 mg/kg BID, n=12, 2
2.388
(1.364 to 4.180)
3.823 [1] 
(NA to NA)
[1]
The 95% CI is not available because the number of participants analyzed is 2.
23.Secondary Outcome
Title Plasma RTV Cτ
Hide Description The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.
Time Frame Week 48
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Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 33
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
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)
24.Secondary Outcome
Title Plasma RTV CL/F Expressed in mL/Min/kg
Hide 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
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Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min/kg
7 mg/kg BID, n=2, 22
58.668 [1] 
(NA to NA)
14.960
(9.762 to 22.927)
10 mg/kg BID, n=11, 2
12.118
(6.435 to 22.818)
8.938 [1] 
(NA to NA)
[1]
The 95% CI is not available because the number of participants analyzed is 2.
25.Secondary Outcome
Title Plasma RTV CL/F Expressed in mL/Min
Hide 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
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Hide Analysis Population Description
PK Population. Only those participants contributing data were analyzed.
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 11 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min
7 mg/kg BID, n=2, 22
335.2 [1] 
(NA to NA)
134.1
(87.3 to 205.8)
10 mg/kg BID, n=11, 2
72.1
(38.7 to 134.3)
57.9 [1] 
(NA to NA)
[1]
The 95% CI is not available because the number of participants analyzed is 2.
26.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
Hide Description A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.
Time Frame Baseline through Week 48
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VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.
Arm/Group Title ART-naïve FPV/RTV Treatment Group PI-naïve, ART-experienced FPV/RTV Treatment Group PI-experienced, ART-experienced FPV/RTV Treatment Group
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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, 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, 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.
Overall Number of Participants Analyzed 2 3 2
Measure Type: Number
Unit of Measure: 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
27.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
Hide Description A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.
Time Frame Baseline through Week 48
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VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable
Arm/Group Title ART-naïve FPV/RTV Treatment Group ART-experienced, PI-naïve FPV/RTV Treatment Group PI-experienced, ART-experienced FPV/RTV Treatment Group
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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, 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, 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.
Overall Number of Participants Analyzed 2 3 2
Measure Type: Number
Unit of Measure: 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
28.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: 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
29.Secondary Outcome
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
Hide 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
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Safety Population
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: 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
30.Secondary Outcome
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
Hide 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
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Safety Population
Arm/Group Title FPV/RTV BID
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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.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: 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
31.Secondary Outcome
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
Hide Description No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.
Time Frame Week 48
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PK Population
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
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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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Plasma FPV AUC (0-τ)
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
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PK Population
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
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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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Plasma FPV Cmax and Cτ
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
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PK Population
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
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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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
34.Secondary Outcome
Title Plasma FPV CL/F Expressed in mL/Min/kg
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
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PK Population
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
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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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Plasma FPV CL/F Expressed in mL/Min
Hide Description The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time Frame Week 48
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Hide Analysis Population Description
PK Population
Arm/Group Title FPV/RTV BID: 4 Weeks to <6 Months FPV/RTV BID: 6 Months to <2 Years
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The FPV/RTV BID treatment group includes 5 participants who only received treatment at the single dose visits in APV20002 (Safety Population, n=59).
 
Arm/Group Title FPV/RTV BID
Hide Arm/Group Description 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.
All-Cause Mortality
FPV/RTV BID
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FPV/RTV BID
Affected / at Risk (%)
Total   22/59 (37.29%) 
Blood and lymphatic system disorders   
Neutropenia  1  1/59 (1.69%) 
Gastrointestinal disorders   
Gastroenteritis  1  5/59 (8.47%) 
Abdominal symptom  1  1/59 (1.69%) 
Diarrhea  1  1/59 (1.69%) 
General disorders   
Inflammation  1  1/59 (1.69%) 
Infections and infestations   
Pneumonia  1  5/59 (8.47%) 
Bronchopneumonia  1  4/59 (6.78%) 
Urinary tract infection  1  2/59 (3.39%) 
Bronchiolitis  1  1/59 (1.69%) 
Bronchitis  1  1/59 (1.69%) 
Escherichia urinary tract infection  1  1/59 (1.69%) 
Lower respiratory tract infection  1  1/59 (1.69%) 
Mastoiditis  1  1/59 (1.69%) 
Meningitis  1  1/59 (1.69%) 
Meningitis bacterial  1  1/59 (1.69%) 
Otitis media chronic  1  1/59 (1.69%) 
Pneumonia viral  1  1/59 (1.69%) 
Injury, poisoning and procedural complications   
Greenstick fracture  1  1/59 (1.69%) 
Herbal toxicity  1  1/59 (1.69%) 
Pneumonitis chemical  1  1/59 (1.69%) 
Investigations   
Transaminases increased  1  1/59 (1.69%) 
Metabolism and nutrition disorders   
Hypernatremia  1  1/59 (1.69%) 
Kwashiorkor  1  1/59 (1.69%) 
Malnutrition  1  1/59 (1.69%) 
Nervous system disorders   
Convulsion  1  2/59 (3.39%) 
Febrile convulsion  1  1/59 (1.69%) 
Vascular disorders   
Hypertension  1  2/59 (3.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FPV/RTV BID
Affected / at Risk (%)
Total   50/59 (84.75%) 
Ear and labyrinth disorders   
Otorrhoea  1  5/59 (8.47%) 
Eye disorders   
Conjunctivitis  1  10/59 (16.95%) 
Gastrointestinal disorders   
Diarrhea  1  32/59 (54.24%) 
Vomiting  1  13/59 (22.03%) 
Aphthous stomatitis  1  3/59 (5.08%) 
Dental caries  1  3/59 (5.08%) 
General disorders   
Pyrexia  1  4/59 (6.78%) 
Infections and infestations   
Upper respiratory tract infection  1  21/59 (35.59%) 
Gastroenteritis  1  17/59 (28.81%) 
Nasopharyngitis  1  17/59 (28.81%) 
Pharyngitis  1  17/59 (28.81%) 
Otitis media  1  16/59 (27.12%) 
Rhinitis  1  15/59 (25.42%) 
Tonsillitis  1  10/59 (16.95%) 
Impetigo  1  7/59 (11.86%) 
Otitis media acute  1  7/59 (11.86%) 
Bronchitis  1  6/59 (10.17%) 
Bronchiolitis  1  5/59 (8.47%) 
Acarodermatitis  1  4/59 (6.78%) 
Folliculitis  1  3/59 (5.08%) 
Fungal skin infection  1  3/59 (5.08%) 
Oral candidiasis  1  3/59 (5.08%) 
Oral herpes  1  3/59 (5.08%) 
Tinea infection  1  3/59 (5.08%) 
Investigations   
Blood cholesterol increased  1  11/59 (18.64%) 
Blood triglycerides increased  1  5/59 (8.47%) 
Metabolism and nutrition disorders   
Failure to thrive  1  3/59 (5.08%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  10/59 (16.95%) 
Nasal congestion  1  3/59 (5.08%) 
Skin and subcutaneous tissue disorders   
Dermatitis diaper  1  7/59 (11.86%) 
Seborrhoeic dermatitis  1  7/59 (11.86%) 
Eczema  1  6/59 (10.17%) 
Rash  1  5/59 (8.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00071760     History of Changes
Other Study ID Numbers: APV20002
First Submitted: October 30, 2003
First Posted: October 31, 2003
Results First Submitted: March 2, 2012
Results First Posted: August 23, 2012
Last Update Posted: January 13, 2017