Trial Outcomes & Findings for Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects (NCT NCT00071760)

Last Updated: 2023-10-10

Results Overview

Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where "τ" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Week 48

Results posted on

2023-10-10

Participant Flow

The study was conducted between 23-Oct-2003 to 29-March-2022 in Argentina, Mexico, Portugal and South Africa. The cut off date for 48 week primary endpoint was July 5th 2011.

59 participants were enrolled in the study and received at least one dose of Fosamprenavir (FPV)/Ritonavir (RTV) (Safety Population). Five participants out of 59 only received single dose before discontinuing the study. 54 participants who received both single and multiple doses of FPV/RTV were included in Intent to Treat-Exposed (ITT-E) population.

Participant milestones

Participant milestones
Measure	Cohort 1, Arm A - 6 Months to <2 Years Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.
Overall Study STARTED	28	26
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1, Arm A - 6 Months to <2 Years Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	0	3
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Insufficient Viral Load Response	1	1
Overall Study Lack of availability of RTV	1	0
Overall Study Physician Decision	2	1
Overall Study Relocation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	Total n=54 Participants Total of all reporting groups
Age, Continuous	13.3 Months STANDARD_DEVIATION 5.6 • n=5 Participants	3.4 Months STANDARD_DEVIATION 0.95 • n=7 Participants	8.6 Months STANDARD_DEVIATION 6.43 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=10 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=9 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma Amprenavir (APV) AUC (0-tau[τ]) 60/10 mg/kg BID; n=2, 2	26.22 Hr per microgram/milliliter (hr*µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	54.2 Hr per microgram/milliliter (hr*µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma Amprenavir (APV) AUC (0-tau[τ]) 45/10 mg/kg BID; n=9, 1	64.51 Hr per microgram/milliliter (hr*µg/mL) The 95% CI is not available because the number of participants analyzed is 1.	26.6 Hr per microgram/milliliter (hr*µg/mL) Interval 15.2 to 46.8	—
Plasma Amprenavir (APV) AUC (0-tau[τ]) 45/7 mg/kg BID; n=2, 10	27.5 Hr per microgram/milliliter (hr*µg/mL) Interval 14.5 to 52.1	35.08 Hr per microgram/milliliter (hr*µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma Amprenavir (APV) AUC (0-tau[τ]) 60/7 mg/kg BID; n=0, 8	48.4 Hr per microgram/milliliter (hr*µg/mL) Interval 12.9 to 181.5	—	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

The maximum concentration at steady state (Cmax) was measured.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=10 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=9 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma APV Cmax 45/10 mg/kg BID; n=9, 1	21.82 Micrograms per milliliter (µg/mL) The 95% CI is not available because the number of participants analyzed is 1.	6.25 Micrograms per milliliter (µg/mL) Interval 3.82 to 10.2	—
Plasma APV Cmax 60/10 mg/kg BID; n=2, 2	7.47 Micrograms per milliliter (µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	10.44 Micrograms per milliliter (µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV Cmax 45/7 mg/kg BID; n=2, 10	5.84 Micrograms per milliliter (µg/mL) Interval 3.35 to 10.2	8.20 Micrograms per milliliter (µg/mL) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV Cmax 60/7 mg/kg BID; n=0, 9	10.4 Micrograms per milliliter (µg/mL) Interval 3.64 to 30.0	—	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=29 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=11 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma APV Cτ 60/10 mg/kg BID; n=3, 5	2.58 Micrograms per milliliter (µg/mL) Interval 1.29 to 5.17	0.60 Micrograms per milliliter (µg/mL) Interval to 127.5 Because of the small sample size, the lower limit of the confidence interval cannot be reliably calculated.	—
Plasma APV Cτ 45/10 mg/kg BID; n=11, 15	1.92 Micrograms per milliliter (µg/mL) Interval 1.42 to 2.58	0.86 Micrograms per milliliter (µg/mL) Interval 0.5 to 1.48	—
Plasma APV Cτ 45/7 mg/kg BID; n=3, 29	2.17 Micrograms per milliliter (µg/mL) Interval 1.69 to 2.8	0.44 Micrograms per milliliter (µg/mL) Interval 0.18 to 1.07	—
Plasma APV Cτ 60/7 mg/kg BID; n=0, 12	2.81 Micrograms per milliliter (µg/mL) Interval 1.69 to 4.67	—	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=10 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=9 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg 45/10 mg/kg BID; n=9, 1	10.42 Milliliters/minute/kilogram (mL/min/kg) The 95% CI is not available because the number of participants analyzed is 1.	22.9 Milliliters/minute/kilogram (mL/min/kg) Interval 12.9 to 40.6	—
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg 60/10 mg/kg BID; n=2, 2	31.92 Milliliters/minute/kilogram (mL/min/kg) The 95% CI is not available because the number of participants analyzed is 2.	15.3 Milliliters/minute/kilogram (mL/min/kg) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg 45/7 mg/kg BID; n=2, 10	22.8 Milliliters/minute/kilogram (mL/min/kg) Interval 12.0 to 43.1	17.50 Milliliters/minute/kilogram (mL/min/kg) The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg 60/7 mg/kg BID; n=0, 8	17.8 Milliliters/minute/kilogram (mL/min/kg) Interval 4.75 to 66.7	—	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=10 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=9 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma APV CL/F Following Dosing Expressed in mL/Min 45/10 mg/kg BID; n=9, 1	62.5 mL/min The 95% CI is not available because the number of participants analyzed is 1.	135 mL/min Interval 69.1 to 262.0	—
Plasma APV CL/F Following Dosing Expressed in mL/Min 60/10 mg/kg BID; n=2, 2	234.3 mL/min The 95% CI is not available because the number of participants analyzed is 2.	86.4 mL/min The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV CL/F Following Dosing Expressed in mL/Min 45/7 mg/kg BID; n=2, 10	190 mL/min Interval 93.2 to 386.2	106.7 mL/min The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma APV CL/F Following Dosing Expressed in mL/Min 60/7 mg/kg BID; n=0, 8	172 mL/min Interval 46.3 to 638.0	—	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=16 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=7 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma Unbound APV Cτ 60/10 mg/kg BID; n=1, 7	0.069 µg/mL Standard Deviation 0.052	0.003 µg/mL Standard Deviation NA The standard deviation is not available because the number of participants analyzed is 1.	—
Plasma Unbound APV Cτ 45/7 mg/kg BID; n=1, 16	0.150 µg/mL Standard Deviation 0.086	0.027 µg/mL Standard Deviation NA The standard deviation is not available because the number of participants analyzed is 1.	—
Plasma Unbound APV Cτ 60/7 mg/kg BID; n=0, 12	0.290 µg/mL Standard Deviation 0.310	—	—
Plasma Unbound APV Cτ 45/10 mg/kg BID; n=7, 16	0.087 µg/mL Standard Deviation 0.076	0.091 µg/mL Standard Deviation 0.083	—

PRIMARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=16 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=7 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma Unbound APV Percent Protein Binding (%Cτ) 60/10 mg/kg BID; n=1, 7	5.81 Percentage of total APV Cτ unbound Standard Deviation 1.68	5.32 Percentage of total APV Cτ unbound Standard Deviation NA The standard deviation is not available because the number of participants analyzed is 1.	—
Plasma Unbound APV Percent Protein Binding (%Cτ) 45/7 mg/kg BID; n=1, 16	8.23 Percentage of total APV Cτ unbound Standard Deviation 8.67	7.55 Percentage of total APV Cτ unbound Standard Deviation NA The standard deviation is not available because the number of participants analyzed is 1.	—
Plasma Unbound APV Percent Protein Binding (%Cτ) 45/10 mg/kg BID; n=7, 15	6.56 Percentage of total APV Cτ unbound Standard Deviation 2.27	5.79 Percentage of total APV Cτ unbound Standard Deviation 2.05	—
Plasma Unbound APV Percent Protein Binding (%Cτ) 60/7 mg/kg BID; n=0, 9	9.20 Percentage of total APV Cτ unbound Standard Deviation 5.39	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48

Population: Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Day 1; n=26;30	20.0 International units per liter (IU/L) Interval 9.0 to 884.0	22.0 International units per liter (IU/L) Interval 6.0 to 94.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Week 12; n=22;27	40.0 International units per liter (IU/L) Interval 23.0 to 67.0	35.0 International units per liter (IU/L) Interval 21.0 to 63.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Week 4; n=23;28	15.5 International units per liter (IU/L) Interval 8.0 to 164.0	14.0 International units per liter (IU/L) Interval 6.0 to 25.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Week 12; n=22;27	15.0 International units per liter (IU/L) Interval 8.0 to 39.0	15.0 International units per liter (IU/L) Interval 8.0 to 35.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Week 24; n=22;26	15.5 International units per liter (IU/L) Interval 4.0 to 111.0	16.0 International units per liter (IU/L) Interval 7.0 to 37.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Week 36; n=20;25	16.0 International units per liter (IU/L) Interval 8.0 to 134.0	15.5 International units per liter (IU/L) Interval 10.0 to 51.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 ALT, Week 48; n=18;24	16.0 International units per liter (IU/L) Interval 9.0 to 36.0	15.0 International units per liter (IU/L) Interval 7.0 to 42.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Day 1; n=26;30	44.0 International units per liter (IU/L) Interval 29.0 to 852.0	43.5 International units per liter (IU/L) Interval 24.0 to 165.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Week 4; n=23;28	35.0 International units per liter (IU/L) Interval 23.0 to 150.0	32.0 International units per liter (IU/L) Interval 21.0 to 49.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Week 24; n=22;26	36.5 International units per liter (IU/L) Interval 17.0 to 109.0	34.0 International units per liter (IU/L) Interval 25.0 to 43.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Week 36; n=20;24	34.0 International units per liter (IU/L) Interval 22.0 to 105.0	35.0 International units per liter (IU/L) Interval 21.0 to 58.0	—
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 AST, Week 48; n=18;23	34.0 International units per liter (IU/L) Interval 22.0 to 57.0	34.5 International units per liter (IU/L) Interval 17.0 to 58.0	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48

Population: Safety Population. Only those participants contributing data were analyzed.

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 and triglyceride (TG). Clinical chemistry analyses were carried out using the observed analysis strategy.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Day 1; n=22;29	2.910 Millimoles per liter (mmol/L) Interval 2.64 to 3.53	2.235 Millimoles per liter (mmol/L) Interval 1.9 to 2.78	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Week 4; n=4;2	3.885 Millimoles per liter (mmol/L) Interval 3.22 to 4.55	3.085 Millimoles per liter (mmol/L) Interval 2.43 to 3.18	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Week 12; n=0;2	3.950 Millimoles per liter (mmol/L) Interval 3.3 to 4.55	—	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Week 24; n=22;26	4.000 Millimoles per liter (mmol/L) Interval 3.49 to 5.05	4.175 Millimoles per liter (mmol/L) Interval 3.3 to 5.21	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Week 36; n=3;2	3.150 Millimoles per liter (mmol/L) Interval 2.9 to 3.4	3.030 Millimoles per liter (mmol/L) Interval 1.6 to 3.39	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Cholesterol, Week 48; n=18;24	4.750 Millimoles per liter (mmol/L) Interval 3.85 to 5.285	3.890 Millimoles per liter (mmol/L) Interval 3.27 to 4.7	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Day 1; n=26;30	4.70 Millimoles per liter (mmol/L) Interval 4.4 to 5.2	4.80 Millimoles per liter (mmol/L) Interval 4.5 to 5.2	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Week 4; n=23;28	4.80 Millimoles per liter (mmol/L) Interval 4.2 to 5.2	4.60 Millimoles per liter (mmol/L) Interval 4.3 to 5.3	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Week 12; n=22;27	4.70 Millimoles per liter (mmol/L) Interval 4.3 to 5.3	4.70 Millimoles per liter (mmol/L) Interval 4.1 to 5.5	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Week 24; n=22;26	4.30 Millimoles per liter (mmol/L) Interval 4.0 to 5.0	4.55 Millimoles per liter (mmol/L) Interval 4.0 to 4.9	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Week 36; n=20;25	4.60 Millimoles per liter (mmol/L) Interval 4.3 to 4.8	4.50 Millimoles per liter (mmol/L) Interval 4.35 to 5.1	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 Glucose, Week 48; n=18;24	4.70 Millimoles per liter (mmol/L) Interval 4.35 to 5.15	4.45 Millimoles per liter (mmol/L) Interval 4.2 to 4.9	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Day 1; n=22;29	0.680 Millimoles per liter (mmol/L) Interval 0.5 to 0.85	0.655 Millimoles per liter (mmol/L) Interval 0.41 to 0.81	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Week 4; n=4;2	0.690 Millimoles per liter (mmol/L) Interval 0.65 to 0.73	0.825 Millimoles per liter (mmol/L) Interval 0.585 to 0.97	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Week 12; n=0;2	0.775 Millimoles per liter (mmol/L) Interval 0.65 to 0.9	—	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Week 24; n=22;26	0.960 Millimoles per liter (mmol/L) Interval 0.8 to 1.1	0.900 Millimoles per liter (mmol/L) Interval 0.72 to 1.0	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Week 36; n=3;2	0.805 Millimoles per liter (mmol/L) Interval 0.61 to 1.0	0.640 Millimoles per liter (mmol/L) Interval 0.4 to 0.7	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 HDL, Week 48; n=18;24	1.050 Millimoles per liter (mmol/L) Interval 0.805 to 1.2	0.825 Millimoles per liter (mmol/L) Interval 0.73 to 1.0	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Day 1; n=22;28	1.50 Millimoles per liter (mmol/L) Interval 1.11 to 1.94	0.90 Millimoles per liter (mmol/L) Interval 0.65 to 1.15	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Week 4; n=4;2	2.45 Millimoles per liter (mmol/L) Interval 1.9 to 3.0	1.25 Millimoles per liter (mmol/L) Interval 0.85 to 1.48	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Week 12; n=0;2	2.33 Millimoles per liter (mmol/L) Interval 2.0 to 2.66	—	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Week 24; n=22;26	2.32 Millimoles per liter (mmol/L) Interval 2.0 to 3.1	2.08 Millimoles per liter (mmol/L) Interval 1.1 to 3.1	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Week 36; n=3;2	2.08 Millimoles per liter (mmol/L) Interval 1.75 to 2.4	1.90 Millimoles per liter (mmol/L) Interval 0.3 to 2.1	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 LDL, Week 48; n=18;24	2.80 Millimoles per liter (mmol/L) Interval 2.5 to 3.37	2.33 Millimoles per liter (mmol/L) Interval 1.7 to 2.85	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Day 1; n=22;29	1.650 Millimoles per liter (mmol/L) Interval 1.3 to 2.1	1.695 Millimoles per liter (mmol/L) Interval 1.22 to 2.28	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Week 4; n=4;2	1.645 Millimoles per liter (mmol/L) Interval 1.31 to 1.98	2.015 Millimoles per liter (mmol/L) Interval 1.505 to 2.28	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Week 12; n=0;2	1.810 Millimoles per liter (mmol/L) Interval 0.8 to 2.82	—	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Week 24; n=22;26	1.550 Millimoles per liter (mmol/L) Interval 1.1 to 2.12	2.155 Millimoles per liter (mmol/L) Interval 1.58 to 2.71	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Week 36; n=3;2	1.700 Millimoles per liter (mmol/L) Interval 1.1 to 2.3	1.310 Millimoles per liter (mmol/L) Interval 1.1 to 2.0	—
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 TG, Week 48; n=18;24	1.390 Millimoles per liter (mmol/L) Interval 0.92 to 1.95	1.590 Millimoles per liter (mmol/L) Interval 1.27 to 2.01	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, and 48

Population: Safety Population. Only those participants contributing data were analyzed.

Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=11 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=2 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 Day 1; n=2;11	22.0 Units per liter (U/L) Interval 17.0 to 38.0	20.5 Units per liter (U/L) Interval 20.0 to 21.0	—
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 Week 4; n=0;1	16.0 Units per liter (U/L) Interval 16.0 to 16.0	—	—
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 Week 12; n=0;1	68.0 Units per liter (U/L) Interval 68.0 to 68.0	—	—
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 Week 24; n=0;8	19.5 Units per liter (U/L) Interval 14.5 to 28.0	—	—
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 Week 48; n=1;8	16.0 Units per liter (U/L) Interval 14.5 to 24.0	16.0 Units per liter (U/L) Interval 16.0 to 16.0	—

PRIMARY outcome

Timeframe: Baseline (Day 1) until Week 48

Population: Safety Population. Only those participants contributing data were analyzed.

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. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities Clinical Chemistry Toxicities - Grade 3	4 participants	2 participants	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities Clinical Chemistry Toxicities - Grade 4	1 participants	0 participants	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities Hematology Toxicities - Grade 3	2 participants	2 participants	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities Hematology Toxicities - Grade 4	1 participants	0 participants	—

PRIMARY outcome

Timeframe: Baseline (Day 1) until Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)	10 participants	11 participants	—

PRIMARY outcome

Timeframe: Baseline (Day 1) until Week 48

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants Who Permanently Discontinued the Treatment Due to an AE	2 participants	1 participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 684

Population: Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.

Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 120	11 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 636	2 Participants	1 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Baseline (Day 1)	0 Participants	1 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 4	6 Participants	5 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 12	18 Participants	13 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 24	20 Participants	18 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 36	20 Participants	19 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 48	22 Participants	15 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 60	12 Participants	15 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 72	14 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 84	15 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 96	14 Participants	15 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 108	14 Participants	15 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 132	11 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 144	8 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 156	10 Participants	14 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 168	9 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 180	9 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 192	8 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 204	9 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 216	9 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 228	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 240	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 252	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 264	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 276	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 288	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 300	8 Participants	12 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 312	8 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 324	8 Participants	11 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 336	7 Participants	11 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 348	6 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 360	7 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 372	7 Participants	11 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 384	7 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 396	7 Participants	11 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 408	7 Participants	11 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 420	7 Participants	8 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 432	7 Participants	10 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 444	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 456	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 468	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 480	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 492	7 Participants	7 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 504	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 516	7 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 528	6 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 540	5 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 552	5 Participants	9 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 564	5 Participants	6 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 576	5 Participants	6 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 588	5 Participants	6 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 600	3 Participants	5 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 612	3 Participants	5 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 624	3 Participants	5 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 648	2 Participants	1 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 660	2 Participants	1 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 672	2 Participants	0 Participants	—
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit Week 684	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 684

Population: Intent to treat-exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.

Blood samples of participants were collected to measure plasma HIV-1 RNA copies. Baseline value was defined as the value observed at the day 1 visit or if this value is missing the last value observed before the start of investigational product. Change from baseline value was defined as post-dose value minus baseline value.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=22 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 12	-3.14 Log10 copies/milliliter Interval -3.58 to -2.12	-3.11 Log10 copies/milliliter Interval -3.94 to -1.91	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 120	-3.58 Log10 copies/milliliter Interval -3.9 to -2.82	-4.12 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 180	-3.52 Log10 copies/milliliter Interval -3.9 to -2.95	-4.36 Log10 copies/milliliter Interval -4.71 to -3.9	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 456	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 4	-2.33 Log10 copies/milliliter Interval -2.87 to -1.95	-2.38 Log10 copies/milliliter Interval -2.89 to -1.64	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 24	-3.38 Log10 copies/milliliter Interval -3.88 to -2.39	-3.77 Log10 copies/milliliter Interval -4.21 to -1.91	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 36	-3.52 Log10 copies/milliliter Interval -3.9 to -2.69	-3.72 Log10 copies/milliliter Interval -4.26 to -3.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 48	-3.56 Log10 copies/milliliter Interval -3.92 to -3.12	-3.90 Log10 copies/milliliter Interval -4.48 to -2.28	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 60	-3.12 Log10 copies/milliliter Interval -3.92 to -2.04	-3.89 Log10 copies/milliliter Interval -4.63 to -2.45	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 72	-3.60 Log10 copies/milliliter Interval -3.93 to -2.69	-3.95 Log10 copies/milliliter Interval -4.63 to -2.45	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 84	-3.62 Log10 copies/milliliter Interval -3.98 to -2.97	-3.95 Log10 copies/milliliter Interval -4.63 to -3.11	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 96	-3.70 Log10 copies/milliliter Interval -3.93 to -3.0	-4.26 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 108	-3.80 Log10 copies/milliliter Interval -3.93 to -3.0	-4.26 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 132	-3.52 Log10 copies/milliliter Interval -3.9 to -2.8	-4.09 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 144	-3.52 Log10 copies/milliliter Interval -3.9 to -2.95	-4.12 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 156	-3.34 Log10 copies/milliliter Interval -3.9 to -2.95	-4.12 Log10 copies/milliliter Interval -4.71 to -3.31	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 168	-3.52 Log10 copies/milliliter Interval -3.9 to -2.95	-3.95 Log10 copies/milliliter Interval -4.63 to -3.15	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 192	-3.31 Log10 copies/milliliter Interval -3.9 to -2.87	-4.28 Log10 copies/milliliter Interval -4.71 to -3.9	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 204	-3.52 Log10 copies/milliliter Interval -3.99 to -2.95	-4.22 Log10 copies/milliliter Interval -4.71 to -3.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 216	-3.52 Log10 copies/milliliter Interval -3.99 to -2.95	-4.36 Log10 copies/milliliter Interval -4.71 to -3.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 228	-3.71 Log10 copies/milliliter Interval -4.06 to -3.07	-4.45 Log10 copies/milliliter Interval -4.85 to -3.46	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 240	-3.71 Log10 copies/milliliter Interval -4.06 to -3.07	-4.22 Log10 copies/milliliter Interval -4.64 to -3.46	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 252	-3.71 Log10 copies/milliliter Interval -4.06 to -3.07	-4.22 Log10 copies/milliliter Interval -4.64 to -3.46	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 264	-3.71 Log10 copies/milliliter Interval -4.06 to -3.07	-4.22 Log10 copies/milliliter Interval -4.64 to -3.46	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 276	-3.71 Log10 copies/milliliter Interval -4.06 to -3.07	-4.22 Log10 copies/milliliter Interval -4.64 to -3.46	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 288	-3.71 Log10 copies/milliliter Interval -4.06 to -2.94	-4.22 Log10 copies/milliliter Interval -4.64 to -3.56	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 300	-3.80 Log10 copies/milliliter Interval -4.07 to -3.29	-4.22 Log10 copies/milliliter Interval -4.64 to -3.56	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 312	-3.98 Log10 copies/milliliter Interval -4.07 to -3.36	-4.05 Log10 copies/milliliter Interval -4.61 to -2.25	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 324	-3.87 Log10 copies/milliliter Interval -4.07 to -3.36	-4.01 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 336	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 348	-3.36 Log10 copies/milliliter Interval -3.99 to -3.05	-4.33 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 360	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 372	-3.36 Log10 copies/milliliter Interval -4.13 to -2.79	-4.09 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 384	-3.15 Log10 copies/milliliter Interval -4.13 to -3.05	-4.01 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 396	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 408	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 420	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 432	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.33 Log10 copies/milliliter Interval -4.81 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 444	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.04 Log10 copies/milliliter Interval -4.65 to -2.64	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 468	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 480	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 492	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-3.55 Log10 copies/milliliter Interval -4.61 to -2.5	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 504	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 516	-3.62 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 528	-3.80 Log10 copies/milliliter Interval -4.13 to -3.05	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 540	-3.99 Log10 copies/milliliter Interval -4.13 to -3.62	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 552	-3.99 Log10 copies/milliliter Interval -4.13 to -3.62	-4.09 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 564	-3.99 Log10 copies/milliliter Interval -4.13 to -3.62	-4.28 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 576	-3.99 Log10 copies/milliliter Interval -4.13 to -3.62	-4.04 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 588	-3.99 Log10 copies/milliliter Interval -4.13 to -3.62	-4.04 Log10 copies/milliliter Interval -4.65 to -3.1	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 600	-3.99 Log10 copies/milliliter Interval -4.56 to -3.62	-3.55 Log10 copies/milliliter Interval -4.09 to -1.53	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 612	-3.99 Log10 copies/milliliter Interval -4.56 to -3.62	-4.09 Log10 copies/milliliter Interval -4.65 to -4.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 624	-3.99 Log10 copies/milliliter Interval -4.56 to -3.62	-4.09 Log10 copies/milliliter Interval -4.65 to -4.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 636	-4.27 Log10 copies/milliliter Interval -4.56 to -3.99	-4.00 Log10 copies/milliliter Interval -4.99 to -4.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 648	-4.27 Log10 copies/milliliter Interval -4.56 to -3.99	-4.00 Log10 copies/milliliter Interval -4.0 to -4.0	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 660	-4.27 Log10 copies/milliliter Interval -4.56 to -3.99	-4.09 Log10 copies/milliliter Interval -4.09 to -4.09	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 672	-4.27 Log10 copies/milliliter Interval -4.56 to -3.99	—	—
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit Week 684	-3.99 Log10 copies/milliliter Interval -3.99 to -3.99	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to week 684

Population: Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.

Blood samples of participants were collected for the measurement of the CD4+ cells.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=23 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 612	949 Cells/cubic millimeter Interval 655.0 to 1000.0	720 Cells/cubic millimeter Interval 714.0 to 800.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Baseline (Day 1)	1120 Cells/cubic millimeter Interval 873.5 to 1827.5	1378 Cells/cubic millimeter Interval 950.0 to 1690.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 4	1734.5 Cells/cubic millimeter Interval 1290.0 to 2287.0	1610 Cells/cubic millimeter Interval 1170.0 to 2520.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 12	1822 Cells/cubic millimeter Interval 1120.0 to 2392.0	1405 Cells/cubic millimeter Interval 1107.0 to 1757.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 24	1475.5 Cells/cubic millimeter Interval 1223.0 to 2178.0	1595 Cells/cubic millimeter Interval 1320.0 to 1910.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 36	1523 Cells/cubic millimeter Interval 1200.0 to 2069.0	1780 Cells/cubic millimeter Interval 1620.0 to 2410.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 48	1602 Cells/cubic millimeter Interval 1035.0 to 2345.5	1690 Cells/cubic millimeter Interval 1150.0 to 2080.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 60	1311 Cells/cubic millimeter Interval 944.0 to 1962.0	1890 Cells/cubic millimeter Interval 1544.0 to 1980.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 72	1667 Cells/cubic millimeter Interval 930.0 to 1883.0	1407 Cells/cubic millimeter Interval 1172.0 to 1890.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 84	1490.5 Cells/cubic millimeter Interval 1307.5 to 2516.5	1560 Cells/cubic millimeter Interval 1280.0 to 2044.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 96	1460 Cells/cubic millimeter Interval 1260.0 to 1730.0	1530 Cells/cubic millimeter Interval 1055.0 to 1990.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 108	1343.5 Cells/cubic millimeter Interval 1149.0 to 1610.0	1440 Cells/cubic millimeter Interval 1220.0 to 1820.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 120	1148.5 Cells/cubic millimeter Interval 905.5 to 1735.0	1480 Cells/cubic millimeter Interval 1160.0 to 1940.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 132	1440 Cells/cubic millimeter Interval 1033.0 to 1810.0	1285 Cells/cubic millimeter Interval 1130.0 to 1430.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 144	1562 Cells/cubic millimeter Interval 1141.0 to 1730.0	1250 Cells/cubic millimeter Interval 935.0 to 1480.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 156	1307 Cells/cubic millimeter Interval 1147.0 to 1719.0	1422 Cells/cubic millimeter Interval 990.0 to 1600.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 168	1236 Cells/cubic millimeter Interval 883.0 to 1358.0	1550 Cells/cubic millimeter Interval 1150.0 to 1700.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 180	978 Cells/cubic millimeter Interval 939.0 to 1640.0	1331.5 Cells/cubic millimeter Interval 983.0 to 1700.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 192	1327 Cells/cubic millimeter Interval 877.0 to 1559.0	1339 Cells/cubic millimeter Interval 944.5 to 1644.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 204	1082 Cells/cubic millimeter Interval 960.0 to 1650.0	1160 Cells/cubic millimeter Interval 776.5 to 1690.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 216	909 Cells/cubic millimeter Interval 809.0 to 1497.0	1336 Cells/cubic millimeter Interval 979.5 to 1451.5	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 228	1106 Cells/cubic millimeter Interval 842.0 to 1425.0	1136 Cells/cubic millimeter Interval 910.5 to 1345.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 240	1067 Cells/cubic millimeter Interval 743.5 to 1232.5	1132.5 Cells/cubic millimeter Interval 736.5 to 1464.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 252	1098.5 Cells/cubic millimeter Interval 796.0 to 1454.0	1379 Cells/cubic millimeter Interval 927.0 to 1592.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 264	853 Cells/cubic millimeter Interval 777.0 to 1421.5	1109 Cells/cubic millimeter Interval 990.0 to 1326.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 276	970 Cells/cubic millimeter Interval 803.5 to 1238.0	1180.5 Cells/cubic millimeter Interval 889.5 to 1336.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 288	911.5 Cells/cubic millimeter Interval 832.0 to 1140.5	1063 Cells/cubic millimeter Interval 737.5 to 1330.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 300	990 Cells/cubic millimeter Interval 571.5 to 1188.5	1062 Cells/cubic millimeter Interval 659.0 to 1249.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 312	928.5 Cells/cubic millimeter Interval 858.0 to 1220.0	924 Cells/cubic millimeter Interval 775.0 to 1199.5	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 324	1242 Cells/cubic millimeter Interval 840.4 to 1420.0	980 Cells/cubic millimeter Interval 770.0 to 1310.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 336	1160 Cells/cubic millimeter Interval 711.0 to 1276.0	856 Cells/cubic millimeter Interval 670.0 to 1160.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 348	976 Cells/cubic millimeter Interval 887.0 to 1264.0	1030 Cells/cubic millimeter Interval 840.0 to 1365.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 360	962 Cells/cubic millimeter Interval 759.0 to 1310.0	1151 Cells/cubic millimeter Interval 839.0 to 1240.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 372	926 Cells/cubic millimeter Interval 637.0 to 1545.0	1051 Cells/cubic millimeter Interval 700.0 to 1070.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 384	884 Cells/cubic millimeter Interval 731.0 to 1281.0	950 Cells/cubic millimeter Interval 800.0 to 1158.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 396	900 Cells/cubic millimeter Interval 630.0 to 1148.0	971 Cells/cubic millimeter Interval 805.0 to 1110.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 408	938.5 Cells/cubic millimeter Interval 578.0 to 1106.0	1005 Cells/cubic millimeter Interval 770.0 to 1107.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 420	850 Cells/cubic millimeter Interval 705.0 to 1007.0	840 Cells/cubic millimeter Interval 768.0 to 1130.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 432	918 Cells/cubic millimeter Interval 754.0 to 1121.0	940.5 Cells/cubic millimeter Interval 705.0 to 1138.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 444	860 Cells/cubic millimeter Interval 816.0 to 1139.0	811 Cells/cubic millimeter Interval 745.5 to 990.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 456	832 Cells/cubic millimeter Interval 701.0 to 1080.0	1003 Cells/cubic millimeter Interval 712.0 to 1143.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 468	863 Cells/cubic millimeter Interval 715.0 to 1024.0	910 Cells/cubic millimeter Interval 665.0 to 1211.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 480	1010 Cells/cubic millimeter Interval 760.0 to 1226.0	1063.5 Cells/cubic millimeter Interval 838.0 to 1270.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 492	930 Cells/cubic millimeter Interval 823.0 to 1139.0	839 Cells/cubic millimeter Interval 780.0 to 970.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 504	910 Cells/cubic millimeter Interval 777.0 to 1265.0	887 Cells/cubic millimeter Interval 805.0 to 1013.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 516	994 Cells/cubic millimeter Interval 793.0 to 1121.0	776 Cells/cubic millimeter Interval 699.5 to 952.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 528	892 Cells/cubic millimeter Interval 732.0 to 1136.0	860 Cells/cubic millimeter Interval 690.0 to 1070.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 540	877 Cells/cubic millimeter Interval 798.0 to 1040.0	851 Cells/cubic millimeter Interval 720.0 to 976.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 552	1000 Cells/cubic millimeter Interval 941.0 to 1080.0	756 Cells/cubic millimeter Interval 730.0 to 940.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 564	804 Cells/cubic millimeter Interval 790.0 to 890.0	908 Cells/cubic millimeter Interval 809.0 to 1110.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 576	990 Cells/cubic millimeter Interval 910.0 to 1047.0	792 Cells/cubic millimeter Interval 768.0 to 1013.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 588	1100 Cells/cubic millimeter Interval 870.0 to 1110.0	873 Cells/cubic millimeter Interval 750.0 to 1018.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 600	717 Cells/cubic millimeter Interval 506.0 to 928.0	865.5 Cells/cubic millimeter Interval 813.0 to 936.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 624	720 Cells/cubic millimeter Interval 500.0 to 1020.0	753 Cells/cubic millimeter Interval 678.5 to 884.5	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 636	535 Cells/cubic millimeter Interval 290.0 to 580.0	770 Cells/cubic millimeter Interval 610.0 to 930.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 648	455 Cells/cubic millimeter Interval 450.0 to 460.0	720 Cells/cubic millimeter Interval 660.0 to 780.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 660	610 Cells/cubic millimeter Interval 320.0 to 900.0	750 Cells/cubic millimeter Interval 750.0 to 750.0	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 672	710 Cells/cubic millimeter Interval 490.0 to 930.0	—	—
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit Week 684	580 Cells/cubic millimeter Interval 580.0 to 580.0	—	—

SECONDARY outcome

Timeframe: Post -Week 48 through Week 684

Population: All PK data collected through 5 July 2011 were included in the 48-week analysis results, no data was subsequently collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 684

Population: VF population included participants who failed 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 data. Only participants with an HIV-1 genotype which obtained for both the baseline and the indicated time of VF points were evaluable. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Group.

A blood sample was drawn from participants failing to respond to therapy, and genotyping was performed to identify the mutations present in the baseline (pre-therapy) and the sample obtained at virologic failure (VF). For each participant, the HIV-1 mutations found at the time of failure were compared with any HIV-1 mutations detected 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- NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Participants are grouped by study arm (prior therapy experience), results displayed in this table are from participants who met virologic failure criteria from Week 48 through Week 684.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=2 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=1 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint PRO, L10L/R	0 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint PRO, I62I/V	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Post-Week 48 to Week 684

Population: Virological failure population includes participants who met the protocol definition of definition of virologic failure and for whom an HIV-1 phenotype was obtained at both the baseline (pre-therapy) and at the virologic failure timepoints. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Arm/Group.

A blood sample was drawn from participant failing to respond to therapy, and the mutations present in the virus were identified. Phenotypic resistance was assessed for virologic failure population and evaluated for Protease Inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNTRIs) using Monogram PhenoSense Assay. Virologic failure was defined as having failed to achieve a plasma HIV-RNA of \<400 copies/mL by Week 24 or having had a confirmed HIV-RNA rebound to ≥400 c/mL at any time after achieving a plasma HIV-RNA of \<400 c/mL.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=2 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=1 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility Treatment emergent reduced NNRTI drug susceptibility	0 Participants	0 Participants	—
Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility Treatment emergent reduced NRTI drug susceptibility	0 Participants	0 Participants	—
Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility Treatment emergent reduced PI drug susceptibility	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
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) Baseline	0 participants	1 participants	—
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) Week 4	6 participants	5 participants	—
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) Week 12	18 participants	13 participants	—
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) Week 24	20 participants	18 participants	—
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) Week 36	20 participants	19 participants	—
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) Week 48	22 participants	15 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: 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.

Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 36, n=21;25	1.69 log10 copies/mL Interval 1.69 to 1.8	1.69 log10 copies/mL Interval 1.69 to 2.33	—
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 48, n=18;24	1.69 log10 copies/mL Interval 1.69 to 1.72	1.69 log10 copies/mL Interval 1.69 to 1.69	—
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Baseline, n=26;28	5.51 log10 copies/mL Interval 4.81 to 5.76	5.80 log10 copies/mL Interval 5.17 to 6.3	—
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 4, n=21;28	2.88 log10 copies/mL Interval 2.65 to 3.19	3.29 log10 copies/mL Interval 2.88 to 4.05	—
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 12, n=22;27	2.07 log10 copies/mL Interval 1.69 to 2.72	2.28 log10 copies/mL Interval 1.69 to 3.11	—
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 24, n=22;25	1.74 log10 copies/mL Interval 1.69 to 2.34	1.69 log10 copies/mL Interval 1.69 to 2.27	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 36, n=21;25	-3.52 log10 copies/mL Interval -3.9 to -2.69	-3.72 log10 copies/mL Interval -4.26 to -3.0	—
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 48, n=18;24	-3.56 log10 copies/mL Interval -3.92 to -3.12	-3.90 log10 copies/mL Interval -4.48 to -2.28	—
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 4, n=21;28	-2.33 log10 copies/mL Interval -2.87 to -1.95	-2.38 log10 copies/mL Interval -2.89 to -1.64	—
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 12, n=22;27	-3.14 log10 copies/mL Interval -3.58 to -2.12	-3.11 log10 copies/mL Interval -3.94 to -1.94	—
Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) Week 24, n=22;25	-3.38 log10 copies/mL Interval -3.88 to -2.39	-3.77 log10 copies/mL Interval -4.21 to -1.91	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
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) Week 4	25 participants	16 participants	—
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) Week 12	25 participants	21 participants	—
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) Week 24	23 participants	21 participants	—
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) Week 36	22 participants	19 participants	—
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) Week 48	21 participants	16 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=23 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Baseline, n=23;28	25 Percentage of cells Interval 18.0 to 31.0	27 Percentage of cells Interval 20.0 to 36.0	—
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Week 4, n=23;28	27.5 Percentage of cells Interval 20.5 to 35.0	29 Percentage of cells Interval 23.0 to 37.0	—
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Week 12, n=22;27	32 Percentage of cells Interval 23.0 to 39.4	27.5 Percentage of cells Interval 23.6 to 35.0	—
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Week 24, n=22;26	32.8 Percentage of cells Interval 26.0 to 37.7	31.5 Percentage of cells Interval 27.2 to 34.0	—
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Week 36, n=21;25	29.5 Percentage of cells Interval 28.0 to 36.5	32 Percentage of cells Interval 26.0 to 38.8	—
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 Week 48, n=18;24	31.6 Percentage of cells Interval 23.0 to 38.0	28 Percentage of cells Interval 25.0 to 32.0	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=20 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 Week 4, n=20;28	3.4 Percentage of cells Interval 0.0 to 6.3	3 Percentage of cells Interval -1.0 to 7.5	—
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 Week 12, n=19;27	6 Percentage of cells Interval 2.0 to 8.0	2 Percentage of cells Interval 0.0 to 8.0	—
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 Week 24, n=19;26	6 Percentage of cells Interval 2.6 to 11.0	7 Percentage of cells Interval -1.0 to 12.0	—
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 Week 36, n=18;25	5 Percentage of cells Interval 3.0 to 8.0	8 Percentage of cells Interval 3.0 to 12.0	—
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 Week 48, n=15;24	4.7 Percentage of cells Interval 2.2 to 8.7	5 Percentage of cells Interval -7.0 to 9.0	—

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants contributing data were analyzed.

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.).

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=28 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=26 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With the Indicated Virological Outcome at Week 48 Virological (V) success	20 participants	15 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 V failure (1)	2 participants	3 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 V failure (2)	2 participants	0 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 V failure (3)	1 participants	1 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 V failure (4)	1 participants	2 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 No V data at Week 48 (a)	1 participants	1 participants	—
Number of Participants With the Indicated Virological Outcome at Week 48 No V data at Week 48 (b)	1 participants	4 participants	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=22 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=11 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma Ritonavir (RTV) AUC (0-τ) 7 mg/kg BID; n=2, 22	7.363 hr*µg/mL Interval 4.769 to 11.369	1.921 hr*µg/mL The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma Ritonavir (RTV) AUC (0-τ) 10 mg/kg BID; n=11, 2	18.750 hr*µg/mL The 95% CI is not available because the number of participants analyzed is 2.	12.952 hr*µg/mL Interval 6.932 to 24.2	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

The maximum concentration at steady state (Cmax) was measured.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=23 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=12 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma RTV Cmax 7 mg/kg BID, n=2, 23	1.576 µg/mL Interval 0.991 to 2.506	0.404 µg/mL The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma RTV Cmax 10 mg/kg BID, n=12, 2	3.823 µg/mL The 95% CI is not available because the number of participants analyzed is 2.	2.388 µg/mL Interval 1.364 to 4.18	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=33 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=15 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma RTV Cτ 7 mg/kg BID, n=4, 33	0.2468 µg/mL Interval 0.1875 to 0.3249	0.0795 µg/mL Interval 0.0316 to 0.1996	—
Plasma RTV Cτ 10 mg/kg BID, n=15, 19	0.4200 µg/mL Interval 0.2958 to 0.5962	0.1855 µg/mL Interval 0.1146 to 0.3003	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=22 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=11 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma RTV CL/F Expressed in mL/Min/kg 7 mg/kg BID, n=2, 22	14.960 mL/min/kg Interval 9.762 to 22.927	58.668 mL/min/kg The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma RTV CL/F Expressed in mL/Min/kg 10 mg/kg BID, n=11, 2	8.938 mL/min/kg The 95% CI is not available because the number of participants analyzed is 2.	12.118 mL/min/kg Interval 6.435 to 22.818	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population. Only those participants contributing data were analyzed.

Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=22 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=11 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Plasma RTV CL/F Expressed in mL/Min 7 mg/kg BID, n=2, 22	134.1 mL/min Interval 87.3 to 205.8	335.2 mL/min The 95% CI is not available because the number of participants analyzed is 2.	—
Plasma RTV CL/F Expressed in mL/Min 10 mg/kg BID, n=11, 2	57.9 mL/min The 95% CI is not available because the number of participants analyzed is 2.	72.1 mL/min Interval 38.7 to 134.3	—

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.

A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=3 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=2 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced n=2 Participants PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Any HIV NRTI Mutation	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease HIV NRTI mutation M184V	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Any HIV NNRTI Mutation	0 participants	0 participants	1 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease HIV NNRTI Mutation K101K/E	0 participants	0 participants	1 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Any HIV Major PI Mutations	0 participants	0 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Any Minor HIV PI Mutations	0 participants	2 participants	1 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Minor HIV PI Mutation L10F	0 participants	0 participants	1 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Minor HIV PI Mutation L10I	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Minor HIV PI Mutation L33L/F	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease Minor HIV PI Mutation L33F	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable

A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=3 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=2 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced n=2 Participants PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Emtricitabine	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Any NNRTI	0 participants	0 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Any PI	0 participants	0 participants	1 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Any NRTI	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Lamivudine	0 participants	1 participants	0 participants
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) Ritonavir-boosted Fosamprenavir	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 2, 12, 24, and 48

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

A separate questionnaire was 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. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire Week 2	24 participants	18 participants	—
Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire Week 12	24 participants	17 participants	—
Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire Week 24	21 participants	19 participants	—
Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire Week 48	17 participants	13 participants	—

SECONDARY outcome

Timeframe: Weeks 2, 24, and 48/premature study discontinuation

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=27 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=23 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, odor, like, n=20;24	9 participants	14 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, odor, like, n=15;22	10 participants	10 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, general satisfaction, neutral, n=20;24	9 participants	0 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, general satisfaction, like, n=20;24	9 participants	16 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, general satisfaction, like, n=15;22	9 participants	10 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, color, dislike, n=23;27	5 participants	3 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, color, neutral, n=23;27	13 participants	7 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, color, like, n=23;27	9 participants	13 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, color, dislike, n=20;24	4 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, color, neutral, n=20;24	10 participants	2 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, color, like, n=20;24	10 participants	14 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, color, dislike, n=15;22	7 participants	6 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, color, neutral, n=15;22	7 participants	1 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, color, like, n=15;22	8 participants	8 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, texture, dislike, n=23;27	5 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, texture, neutral, n=23;27	10 participants	7 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, texture, like, n=23;27	12 participants	12 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, texture, dislike, n=20;24	4 participants	6 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, texture, neutral, n=20;24	12 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, texture, like, n=20;24	8 participants	10 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, texture, dislike, n=15;21	6 participants	6 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, texture, neutral, n=15;21	7 participants	1 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, texture, like, n=15;21	8 participants	8 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, odor, dislike, n=23;27	7 participants	1 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, odor, neutral, n=23;27	7 participants	3 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, odor, like, n=23;27	13 participants	19 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, odor, dislike, n=20;24	7 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, odor, neutral, n=20;24	8 participants	2 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, odor, dislike, n=15;22	7 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, odor, neutral, n=15;22	5 participants	1 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, general satisfaction, dislike, n=23;27	5 participants	3 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, general satisfaction, neutral, n=23;27	7 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 2, general satisfaction, like, n=23;27	15 participants	16 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 24, general satisfaction, dislike, n=20;24	6 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, general satisfaction, dislike, n=15;22	9 participants	4 participants	—
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 Week 48, general satisfaction, neutral, n=15;22	4 participants	1 participants	—

SECONDARY outcome

Timeframe: Weeks (W) 2, 24, and 48/premature study discontinuation

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=27 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=23 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
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 W2, Item 5, problem taking a few med., n=23;27	10 participants	10 participants	—
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 W2, Item 5, impossible to take med., n=23;27	1 participants	0 participants	—
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 W24, Item 5, problem taking most med., n=20;23	5 participants	0 participants	—
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 W48, Item 5, problem taking most med., n=14;22	0 participants	0 participants	—
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 W2, Item 7, no problem taking FPV, n=23;27	6 participants	7 participants	—
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 W48, Item 7, few problems taking FPV, n=15;22	8 participants	4 participants	—
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 W2, I9, not as willing to take as other med., n=23;27	9 participants	7 participants	—
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 W2, Item 5, takes all/most med. easily, n=23;27	11 participants	10 participants	—
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 W2, Item 5, problem taking most med., n=23;27	5 participants	3 participants	—
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 W24, Item 5, takes all/most med. easily, n=20;23	10 participants	12 participants	—
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 W24, Item 5, problem taking a few med., n=20;23	7 participants	8 participants	—
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 W24, Item 5, impossible to take med., n=20;23	1 participants	0 participants	—
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 W48, Item 5, takes all/most med. easily, n=14;22	17 participants	10 participants	—
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 Week 48, Item 5, problem taking a few med., n=14;22	5 participants	4 participants	—
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 W48, Item 5, impossible to take med., n=14;22	0 participants	0 participants	—
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 W2, Item 6, dislike, n=23;27	9 participants	12 participants	—
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 W2, Item 6, neutral, n=23;27	10 participants	4 participants	—
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 W2, Item 6, like, n=23;27	8 participants	7 participants	—
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 W24, Item 6, dislike, n=20;23	12 participants	11 participants	—
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 W24, Item 6, neutral, n=20;23	5 participants	3 participants	—
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 W24, Item 6, like, n=20;23	6 participants	6 participants	—
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 W48, Item 6, dislike, n=15;22	10 participants	9 participants	—
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 W48, Item 6, neutral, n=15;22	6 participants	1 participants	—
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 W48, Item 6, like, n=15;22	6 participants	5 participants	—
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 W2, Item 7, few problems taking FPV, n=23;27	9 participants	9 participants	—
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 W2, Item 7, problem taking most of time, n=23;27	10 participants	5 participants	—
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 W2, Item 7, impossible to take, n=23;27	2 participants	2 participants	—
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 W24, Item 7, no problem taking FPV, n=20;23	10 participants	13 participants	—
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 W24, Item 7, few problems taking FPV, n=20;23	5 participants	3 participants	—
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 W24, Item 7, problem taking most of time, n=20;23	8 participants	4 participants	—
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 W24, Item 7, impossible to take, n=20;23	0 participants	0 participants	—
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 W48, Item 7, no problem taking FPV, n=15;22	10 participants	8 participants	—
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 W48, Item 7, problem taking most of time, n=15;22	2 participants	2 participants	—
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 W48, Item 7, impossible to take, n=15;22	2 participants	1 participants	—
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 W2, Item 8, swallows with no problem, n=23;27	10 participants	9 participants	—
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 W2, Item 8, swallows with struggle, n=23;27	10 participants	11 participants	—
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 W2, Item 8, spits out suspension, n=23;27	5 participants	0 participants	—
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 W2, Item 8, vomits the suspension, n=23;27	2 participants	3 participants	—
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 W24, Item 8, swallows with no problem, n=20;23	12 participants	10 participants	—
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 W24, Item 8, swallows with struggle, n=20;23	9 participants	7 participants	—
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 W24, Item 8, spits out suspension, n=20;23	2 participants	3 participants	—
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 W24, Item 8, vomits the suspension, n=20;23	0 participants	0 participants	—
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 W48, Item 8, swallows with no problem, n=15;22	12 participants	11 participants	—
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 W48, Item 8, swallows with struggle, n=15;22	8 participants	3 participants	—
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 W48, Item 8, spits out suspension, n=15;22	1 participants	1 participants	—
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 W48, Item 8, vomits the suspension, n=15;22	1 participants	0 participants	—
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 W2, I9, take more willingly than other med., n=23;27	3 participants	3 participants	—
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 W2, Item 9, about the same, n=23;27	15 participants	13 participants	—
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 W24, I9, take more willingly than other med., n=20;22	1 participants	3 participants	—
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 W24, Item 9, about the same, n=20;22	20 participants	11 participants	—
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 W24, I9, not as willing to take as other med, n=20;22	1 participants	6 participants	—
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 W48, I9, take more willingly than other med., n=15;22	6 participants	5 participants	—
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 W48, Item 9, about the same, n=15;22	14 participants	10 participants	—
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 W48, I9, not as willing to take as other med, n=15;22	2 participants	0 participants	—
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 Week 2, Item 10, dislike, n=23;27	9 participants	11 participants	—
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 Week 2, Item 10, neutral, n=23;27	9 participants	5 participants	—
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 Week 2, Item 10, like, n=23;27	9 participants	7 participants	—
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 Week 24, Item 10, dislike, n=20;24	13 participants	7 participants	—
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 Week 24, Item 10, neutral, n=20;24	7 participants	2 participants	—
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 Week 24, Item 10, like, n=20;24	4 participants	11 participants	—
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 Week 48, Item 10, dislike, n=15;22	8 participants	7 participants	—
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 Week 48, Item 10, neutral, n=15;22	7 participants	4 participants	—
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 Week 48, Item 10, like, n=15;22	7 participants	4 participants	—

SECONDARY outcome

Timeframe: Week 48

Population: PK Population

No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: PK Population

The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: PK Population

The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: PK Population

The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: PK Population

The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and up to week 684

Population: Safety population included participants receiving FPV or FPV/RTV at any dose.

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Treatment Emergent Adverse Events (AEs)	29 Participants	25 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and up to Week 684

Population: Safety Population

Blood samples were collected for the analysis of all clinical chemistry parameters. Laboratory toxicities were graded using the Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 clinical chemistry toxicities is presented.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Clinical Chemistry Toxicities Grade 1	5 Participants	5 Participants	—
Number of Participants With Clinical Chemistry Toxicities Grade 2	14 Participants	9 Participants	—
Number of Participants With Clinical Chemistry Toxicities Grade 3	7 Participants	3 Participants	—
Number of Participants With Clinical Chemistry Toxicities Grade 4	1 Participants	1 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and up to Week 684

Population: Safety Population

Blood samples were collected for the analysis of all hematology parameters. Laboratory toxicities were graded using the DAIDS Table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 hematology toxicities is presented.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Hematology Toxicities Grade 1	6 Participants	6 Participants	—
Number of Participants With Hematology Toxicities Grade 2	6 Participants	5 Participants	—
Number of Participants With Hematology Toxicities Grade 3	2 Participants	3 Participants	—
Number of Participants With Hematology Toxicities Grade 4	2 Participants	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and up to Week 684

Population: Safety Population

Treatment limiting toxicities are defined as those that are related to investigational medicinal products and deemed to be unacceptable, leading to restriction of further dose escalation.

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants With Treatment Limiting Toxicities	0 Participants	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and up to Week 684

Population: Intent-to-Treat exposed

Outcome measures

Outcome measures
Measure	Cohort 1, Arm A - 6 Months to <2 Years n=30 Participants Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 Participants Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	PI-Experienced PI-Experienced participants with HIV-1 of age group-6 months to \<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \<6 months were administered with FPV/RTV 45/10 mg/kg BID.
Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event	1 Participants	1 Participants	—

Adverse Events

Cohort 2, Arm A - 4 Weeks to <6 Months

Serious events: 13 serious events

Other events: 24 other events

Deaths: 1 deaths

Cohort 1, Arm A - 6 Months to <2 Years

Serious events: 12 serious events

Other events: 28 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 2, Arm A - 4 Weeks to <6 Months n=29 participants at risk Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.	Cohort 1, Arm A - 6 Months to <2 Years n=30 participants at risk Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.
Blood and lymphatic system disorders Neutropenia	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	6.7% 2/30 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Congenital, familial and genetic disorders Hydrocele	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Eye disorders Iridocyclitis	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Gastrointestinal disorders Abdominal symptom	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Gastrointestinal disorders Diarrhoea	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
General disorders Inflammation	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Hepatobiliary disorders Hypertransaminasaemia	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Arthritis bacterial	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Bronchiolitis	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Escherichia urinary tract infection	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Gastroenteritis	17.2% 5/29 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Lower respiratory tract infection	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Mastoiditis	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Meningitis	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Meningitis bacterial	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Otitis media chronic	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Pneumonia	17.2% 5/29 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	13.3% 4/30 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Pneumonia viral	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Tracheobronchitis	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Tuberculosis	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Injury, poisoning and procedural complications Greenstick fracture	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Injury, poisoning and procedural complications Herbal toxicity	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Injury, poisoning and procedural complications Pneumonitis chemical	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Injury, poisoning and procedural complications Thermal burn	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Metabolism and nutrition disorders Hypernatraemia	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Metabolism and nutrition disorders Kwashiorkor	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Metabolism and nutrition disorders Malnutrition	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	3.3% 1/30 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Nervous system disorders Febrile convulsion	3.4% 1/29 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Nervous system disorders Seizure	0.00% 0/29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	6.7% 2/30 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.
Vascular disorders Hypertension	6.9% 2/29 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.	0.00% 0/30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks. All participants received FPV or FPV/RTV at any dose were included in the safety population.