Study Of An Investigational Regimen Including FDA Approve... | NCT00071760

Name	Class
GlaxoSmithKline	INDUSTRY

Label	Type	Description	Intervention Names
Arm A - 4weeks - less than 2 years old (FPV/RTV bid)	Experimental	Cohort 2A - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID) Cohort 1A - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)	Drug: GW433908 Drug: ritonavir
Arm B- 4weeks - less than 2 years old (FPV bid)	Experimental	Cohort 2B - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID) Cohort 1B - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)	Drug: GW433908

Name	Type	Description	Arm Group Labels	Other Names
GW433908	Drug	Fosamprenavir suspension bid	Arm A - 4weeks - less than 2 years old (FPV/RTV bid) Arm B- 4weeks - less than 2 years old (FPV bid)

Measure	Description	Time Frame
Plasma Amprenavir (APV) AUC (0-tau[τ])	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.	Week 48
Plasma APV Cmax	The maximum concentration at steady state (Cmax) was measured.	Week 48
Plasma APV Cτ	The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.	Week 48
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg	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.	Week 48
Plasma APV CL/F Following Dosing Expressed in mL/Min	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).	Week 48
Plasma Unbound APV Cτ

Measure	Description	Time Frame
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit	Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations.	Baseline (Day 1) and up to Week 684
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 4 weeks to <2 years of age. Cohort 1 (6 months - <2 years): Subjects must be <2 years of age at the Week 2 visit therefore the maximum age at screening is 22 months.

Cohort 2 (4 weeks - <6 months): Subjects must be <6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort.

Parent or legal guardian is willing and able to provide written informed consent for the subject to participate in the trial.
Screening plasma HIV-1 RNA level >=400copies/mL.
Subjects who, in the investigator's opinion, and following viral resistance testing if conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone regimen consisting of 2 NRTIs.
Subjects must meet one of the following criteria:

Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI).

PI-experienced subjects defined as having prior experience with no more than three PIs. Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.

Exclusion Criteria:

Prior history of having received APV.
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to study drug administration (single or multiple dose) or anticipated need for concurrent NNRTI therapy during the study period.
PI therapy within 5 days prior to study drug administration (applicable only for subjects undergoing single dose visits)
Subjects and/or parents/legal guardians who, in the investigator's opinion, are not able to comply with the requirements of the study.
Subject is in the initial acute phase of a Centers for Disease Control and Prevention (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline. Subject may be enrolled provided they are receiving treatment for the infections, such treatment not being contraindicated with FPV, and subjects are clinically improving at the Baseline visit.
Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia, diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
Grade 3 or higher (>10x ULN) serum aminotransferase levels (alanine aminotransferase, ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug administration and / or clinically relevant hepatitis within the previous 6 months.
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period.
Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration.
Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study:

Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been excluded for safety reasons).

Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations).

Treatment with other investigational drugs/therapies within 28 days prior to receiving study medication (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor).
History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g. documented hypersensitivity to a nucleoside analogue).

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Jacksonville	Florida	32209	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
23811743	Background	Cotton M, Cassim H, Pavia-Ruz N, Garges HP, Perger T, Ford SL, Wire MB, Givens N, Ross LL, Lou Y, Sievers J, Cheng K. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-infected children aged 4 weeks to 2 years-48-week study data. Pediatr Infect Dis J. 2014 Jan;33(1):57-62. doi: 10.1097/INF.0b013e3182a1123a.

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 20, 2019	Mar 27, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Plasma Amprenavir (APV) AUC (0-tau[τ])

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.

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

Posted

Geometric Mean

95% Confidence Interval

Hr per microgram/milliliter (hr*µg/mL)

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Units	Counts
Participants	OG0009 OG00110

Title

Denominators

Categories

45/10 mg/kg BID; n=9, 1

- ParticipantsOG0009
- ParticipantsOG0011

Title	Measurements
	OG00026.6(15.2 to 46.8)

Primary

Plasma APV Cmax

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

PK Population. Only those participants contributing data were analyzed.

Posted

Least Squares Mean

95% Confidence Interval

Micrograms per milliliter (µg/mL)

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Plasma APV Cτ

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

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

Micrograms per milliliter (µg/mL)

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Plasma APV CL/F Following Dosing Expressed in mL/Min/kg

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.

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

Milliliters/minute/kilogram (mL/min/kg)

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Plasma APV CL/F Following Dosing Expressed in mL/Min

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).

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

mL/min

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Plasma Unbound APV Cτ

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.

PK Population. Only those participants contributing data were analyzed.

Posted

Mean

Standard Deviation

µg/mL

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Plasma Unbound APV Percent Protein Binding (%Cτ)

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.

PK Population. Only those participants contributing data were analyzed.

Posted

Mean

Standard Deviation

Percentage of total APV Cτ unbound

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Primary

Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48

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.

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

Posted

Median

Inter-Quartile Range

International units per liter (IU/L)

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

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

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.

Safety Population. Only those participants contributing data were analyzed.

Posted

Median

Inter-Quartile Range

Millimoles per liter (mmol/L)

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48

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.

Safety Population. Only those participants contributing data were analyzed.

Posted

Median

Inter-Quartile Range

Units per liter (U/L)

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities

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.

Safety Population. Only those participants contributing data were analyzed.

Posted

Number

participants

Baseline (Day 1) until Week 48

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)

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.

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.

Posted

Number

participants

Baseline (Day 1) until Week 48

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants Who Permanently Discontinued the Treatment Due to an AE

Posted

Number

participants

Baseline (Day 1) until Week 48

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Number of Participants With Treatment Emergent Adverse Events (AEs)

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.

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

Posted

Count of Participants

Participants

Day 1 and up to week 684

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Number of Participants With Clinical Chemistry Toxicities

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.

Safety Population

Posted

Count of Participants

Participants

Day 1 and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Number of Participants With Hematology Toxicities

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.

Safety Population

Posted

Count of Participants

Participants

Day 1 and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Number of Participants With Treatment Limiting Toxicities

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.

Safety Population

Posted

Count of Participants

Participants

Day 1 and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event

Intent-to-Treat exposed

Posted

Count of Participants

Participants

Day 1 and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit

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

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

Posted

Count of Participants

Participants

Baseline (Day 1) and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit

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.

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

Posted

Median

Inter-Quartile Range

Log10 copies/milliliter

Baseline (Day 1) and up to Week 684

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit

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

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

Posted

Median

Inter-Quartile Range

Cells/cubic millimeter

Baseline (Day 1) and up to week 684

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Plasma FPV Concentrations

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

Posted

Post -Week 48 through Week 684

ID	Title	Description
OG000	FPV/RTV BID	Participants with Human immunodeficiency virus (HIV-1) of age group-6 months to <2 years were administered with fosamprenavir (FPV)/ritonavir (RTV) 45/7 milligrams per kilogram (mg/kg) twice a day (BID) and participants with HIV-1 of age group - 4 weeks to <6 months were administered with FPV/RTV 45/10 mg/kg BID. FPV/RTV BID arm also include participants who only received treatment at single dose visits (SDV).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint

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.

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.

Posted

Count of Participants

Participants

Week 48 to Week 684

ID	Title	Description
OG000	ART-Naive	Antiretroviral therapy (ART) Naive 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.

Secondary

Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility

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.

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.

Posted

Count of Participants

Participants

Post-Week 48 to Week 684

ID	Title	Description
OG000	ART-Naive	Antiretroviral therapy (ART) Naive 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.
OG001	PI-Naive	PI-Naive 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.

Secondary

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)

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.

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.

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)

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

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.

Posted

Median

Inter-Quartile Range

log10 copies/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)

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.

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.

Posted

Median

Inter-Quartile Range

log10 copies/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)

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.

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

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48

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.

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

Posted

Median

Inter-Quartile Range

Percentage of cells

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48

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.

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.

Posted

Median

Inter-Quartile Range

Percentage of cells

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With the Indicated Virological Outcome at Week 48

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.).

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

Posted

Number

participants

Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Plasma Ritonavir (RTV) AUC (0-τ)

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.

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

hr*µg/mL

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma RTV Cmax

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

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma RTV Cτ

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

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma RTV CL/F Expressed in mL/Min/kg

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.

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

mL/min/kg

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma RTV CL/F Expressed in mL/Min

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

PK Population. Only those participants contributing data were analyzed.

Posted

Geometric Mean

95% Confidence Interval

mL/min

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease

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.

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.

Posted

Number

participants

Baseline through Week 48

ID	Title	Description
OG000	ART-naïve FPV/RTV Treatment Group	ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.

Secondary

Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)

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.

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

Posted

Number

participants

Baseline through Week 48

ID	Title	Description
OG000	ART-naïve FPV/RTV Treatment Group	ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.

Secondary

Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire

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.

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

Posted

Number

participants

Weeks 2, 12, 24, and 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4

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.

Safety Population

Posted

Number

participants

Weeks 2, 24, and 48/premature study discontinuation

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10

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.

Safety Population

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events

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

PK Population

Posted

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma FPV AUC (0-τ)

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

PK Population

Posted

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma FPV Cmax and Cτ

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

PK Population

Posted

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma FPV CL/F Expressed in mL/Min/kg

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

PK Population

Posted

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Secondary

Plasma FPV CL/F Expressed in mL/Min

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

PK Population

Posted

Week 48

ID	Title	Description
OG000	FPV/RTV BID: 4 Weeks to <6 Months	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
OG001	FPV/RTV BID: 6 Months to <2 Years	Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected30 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Iridocyclitis	Eye disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Abdominal symptom	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Inflammation	General disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Arthritis bacterial	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Bronchiolitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Gastroenteritis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0005 events5 affected29 at risk EG0011 events1 affected30 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Mastoiditis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Meningitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Meningitis bacterial	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Otitis media chronic	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Pneumonia	Infections and infestations	MedDRA v25	Systematic Assessment	EG0005 events5 affected29 at risk EG0014 events4 affected30 at risk
Pneumonia viral	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Tracheobronchitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Tuberculosis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Urinary tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Greenstick fracture	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Herbal toxicity	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Pneumonitis chemical	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Kwashiorkor	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Febrile convulsion	Nervous system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Seizure	Nervous system disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected30 at risk
Hypertension	Vascular disorders	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected30 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Otorrhoea	Ear and labyrinth disorders	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events3 affected30 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events2 affected30 at risk
Dental caries	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0006 events6 affected29 at risk EG0016 events6 affected30 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG00019 events19 affected29 at risk EG00115 events15 affected30 at risk
Vomiting	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0008 events8 affected29 at risk EG0018 events8 affected30 at risk
Pyrexia	General disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0015 events5 affected30 at risk
Abdominal infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected30 at risk
Acarodermatitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0013 events3 affected30 at risk
Bronchiolitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected30 at risk
Bronchitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0012 events2 affected30 at risk
Conjunctivitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0008 events8 affected29 at risk EG0013 events3 affected30 at risk
Folliculitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected30 at risk
Fungal skin infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0010 events0 affected30 at risk
Gastroenteritis	Infections and infestations	MedDRA v25	Systematic Assessment	EG00014 events14 affected29 at risk EG0017 events7 affected30 at risk
Helminthic infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0005 events5 affected29 at risk EG0012 events2 affected30 at risk
Impetigo	Infections and infestations	MedDRA v25	Systematic Assessment	EG0008 events8 affected29 at risk EG0012 events2 affected30 at risk
Influenza	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected30 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected30 at risk
Nasopharyngitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0007 events7 affected29 at risk EG00110 events10 affected30 at risk
Oral candidiasis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected30 at risk
Oral herpes	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0015 events5 affected30 at risk
Otitis media	Infections and infestations	MedDRA v25	Systematic Assessment	EG0007 events7 affected29 at risk EG00111 events11 affected30 at risk
Otitis media acute	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0014 events4 affected30 at risk
Pharyngitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0008 events8 affected29 at risk EG00113 events13 affected30 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected30 at risk
Rhinitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0009 events9 affected29 at risk EG00111 events11 affected30 at risk
Skin infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected30 at risk
Tinea capitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0007 events7 affected29 at risk EG0012 events2 affected30 at risk
Tinea infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0010 events0 affected30 at risk
Tonsillitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0009 events9 affected29 at risk EG0015 events5 affected30 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG00015 events15 affected29 at risk EG00112 events12 affected30 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected30 at risk
Blood cholesterol	Investigations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0012 events2 affected30 at risk
Blood cholesterol increased	Investigations	MedDRA v25	Systematic Assessment	EG0007 events7 affected29 at risk EG0016 events6 affected30 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected30 at risk
Blood triglycerides increased	Investigations	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected30 at risk
Cardiac murmur	Investigations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected30 at risk
Weight decreased	Investigations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected30 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected30 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected30 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0005 events5 affected29 at risk EG0011 events1 affected30 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG00012 events12 affected29 at risk EG0019 events9 affected30 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected30 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected30 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected30 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected30 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0006 events6 affected29 at risk EG0011 events1 affected30 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0008 events8 affected29 at risk EG0015 events5 affected30 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected30 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0006 events6 affected29 at risk EG0013 events3 affected30 at risk
Herpes simplex	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected30 at risk
Measles	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected30 at risk
Molluscum contagiosum	Infections and infestations	MedDRA v25	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected30 at risk
Mumps	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Otitis externa	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Otitis media chronic	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Varicella	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Viral rash	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events2 affected30 at risk
Acute sinusitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Bacterial infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Bartholin's abscess	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
COVID-19	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Candida infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Candida nappy rash	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Cellulitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Erythema infectiosum	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Fungal infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hordeolum	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Oral infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Pneumonia	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Post procedural infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Respiratory tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Sinusitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Skin candida	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Tinea cruris	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Tinea faciei	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Body tinea	Infections and infestations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Gingivitis	Infections and infestations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected30 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Cheilitis	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Constipation	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Nausea	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Teething	Gastrointestinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Pityriasis alba	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected30 at risk
Alanine aminotransferase increased	Investigations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Blood glucose increased	Investigations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Blood sodium increased	Investigations	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Neutrophil count decreased	Investigations	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Underweight	Metabolism and nutrition disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected30 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Developmental delay	General disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Conjunctivitis allergic	Eye disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected30 at risk
Chalazion	Eye disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Eye allergy	Eye disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Strabismus	Eye disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Febrile convulsion	Nervous system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Headache	Nervous system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Ichthyosis	Congenital, familial and genetic disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Immunisation reaction	Immune system disorders	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Dysuria	Renal and urinary disorders	MedDRA v25	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected30 at risk
Educational problem	Social circumstances	MedDRA v25	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected30 at risk

ID	Term
D007239	Infections
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	29	13	29	24	29
EG001	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.	2	30	12	30	28	30