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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00040664

First received: July 5, 2002

Last updated: January 24, 2011

Last verified: January 2011

History of Changes

Results First Received: August 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infection
Interventions:	Drug: ritonavir Drug: fosamprenavir

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

[1]	All (69) enrolled on QD; 10 switched to twice daily. Participant flow not collected for this group.

Baseline Characteristics

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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
Number of Participants [units: participants]	69
Age [units: years] Mean ± Standard Deviation	10.2 ± 4.6
Gender [units: participants]
Female	39
Male	30
Race/Ethnicity, Customized [units: participants]
White/Caucasian	35
Black	24
East and South East Asian	1
American Hispanic	8
African Heritage	1

Outcome Measures

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1. Primary:

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

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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) ]

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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) ]

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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 ]

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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 ]

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6. Primary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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. ]

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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. ]

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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 ]

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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 ]

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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 ]

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Measure Type	Secondary
Measure Title	Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits
Measure Description	A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.
Time Frame	Baseline and Weeks 12, 48, 96, and 168
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.

Reporting Groups

	Description
PI-Naive	Participants with equal to or less than 1 week of treatment with a PI
PI-Experienced	Participants treated with equal to or less than 3 PIs (any length of time)

Measured Values

	PI-Naive	PI-Experienced
Number of Participants Analyzed [units: participants]	32	37
Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits [units: Cells/mm3] Median ( Inter-Quartile Range )
Week 12	95 ( 10 to 150 )	40 ( -30 to 110 )
Week 48	150 ( 75 to 280 )	120 ( 0 to 240 )
Week 96	160 ( 55 to 280 )	40 ( -180 to 180 )
Week 168	180 ( 10 to 430 )	0 ( -220 to 200 )

No statistical analysis provided for Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00040664 History of Changes
Other Study ID Numbers:	APV 20003
Study First Received:	July 5, 2002
Results First Received:	August 6, 2009
Last Updated:	January 24, 2011
Health Authority:	Canada: Health Canada Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines United States: Food and Drug Administration

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