A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cohorts were recruited in parallel. All Age Cohorts were given the same treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The overall study population consisted of 69 participants presented as "Overall Fosamprenavir (FPV)/ritonavir (RTV)" in the Participant Flow section. Furthermore, the Overall FPV/RTV participants are stratified by age cohorts (Arms 2-4).

Reporting Groups

	Description
Overall Fosamprenavir (FPV)/Ritonavir(RTV)	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
2-5 Years FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
6-11 Years FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
12-18 Years FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years

Participant Flow:   Overall Study

	Overall Fosamprenavir (FPV)/Ritonavir(RTV)	2-5 Years FPV/RTV	6-11 Years FPV/RTV	12-18 Years FPV/RTV
STARTED	69 [1]	17	17	35
COMPLETED	16	4	4	8
NOT COMPLETED	53	13	13	27
Adverse Event	12	3	2	7
Lack of Efficacy	9	2	3	4
Insufficient CD4 response	1	0	1	0
Lost to Follow-up	4	2	0	2
Protocol Violation	2	1	0	1
Withdrawal by Subject	7	0	3	4
Pregnancy	3	0	0	3
Medication adherence/compliance problems	8	2	1	5
Poor taste	2	0	2	0
Pharmacokinetic target not achieved	2	1	0	1
Change of formulation	2	2	0	0
Non-viability of oral suspension	1	0	1	0

Population Description

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

	Description
FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)

Baseline Measures

	FPV/RTV
Overall Participants Analyzed  [Units: Participants]	69
Age  [Units: Years] Mean (Standard Deviation)	10.2  (4.6)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	39  56.5%
Male	30  43.5%
Race/Ethnicity, Customized  [Units: Participants]
White/Caucasian	35
Black	24
East and South East Asian	1
American Hispanic	8
African Heritage	1

1.  Primary:

Number of Participants Who Discontinued Treatment Due to Adverse Events   [ Time Frame: Baseline through end of study (at least Week 168) ]

2.  Primary:

Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event   [ Time Frame: Baseline through end of study (at least Week 168) ]

3.  Primary:

Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities   [ Time Frame: Baseline through end of study (at least Week 168) ]

4.  Primary:

Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

5.  Primary:

Geometric Mean of Steady State Plasma APV Parameter: Cmax   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

6.  Primary:

Median Steady State Plasma APV Tmax   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

7.  Primary:

Geometric Mean of Steady State Plasma APV Parameter: CL/F   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

8.  Primary:

Geometric Mean of Steady State Plasma APV Parameter: CL/F   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

9.  Primary:

Geometric Mean of Steady State Plasma APV Parameter: t1/2   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

10.  Primary:

Least Squares Mean of Plasma APV Parameter: AUC0-tau   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]

11.  Primary:

Least Squares Mean of Plasma APV Parameter: Cmax   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4. ]

12.  Primary:

Least Squares Mean of Plasma APV Parameter: Ctau   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4. ]

13.  Secondary:

Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)   [ Time Frame: Weeks 12, 48, 96, and 168 ]

14.  Secondary:

Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits   [ Time Frame: Baseline and Weeks 12, 48, 96, and 168 ]

15.  Secondary:

Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits   [ Time Frame: Baseline and Weeks 12, 48, 96, and 168 ]

16.  Secondary:

Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline   [ Time Frame: Time of virologic failure ]

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