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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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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.
No text entered.

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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Measure Type Primary
Measure Title Number of Participants Who Discontinued Treatment Due to Adverse Events
Measure Description The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
Time Frame Baseline through end of study (at least Week 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.
Safety Population: all participants with documented evidence of having received at least one dose of study drug

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)

Measured Values
    FPV/RTV  
Number of Participants Analyzed  
[units: participants]
 		  69  
Number of Participants Who Discontinued Treatment Due to Adverse Events  
[units: Participants]
 		 
Any event     12  
Nausea     3  
Vomiting     3  
Stomach discomfort     1  
Hyperglycaemia     1  
Hypertriglyceridaemia     1  
Blood alkaline phosphatase increased     1  
Hodgkin's disease     1  
Haemoptysis     1  

No statistical analysis provided for Number of Participants Who Discontinued Treatment Due to Adverse Events



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. ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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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  More Information
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