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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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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
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Discontinued Treatment Due to Adverse Events   [ Time Frame: Baseline through end of study (at least Week 168) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 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 ]
  Show Outcome Measure 5

6.  Primary:   Median Steady State Plasma APV Tmax   [ Time Frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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. ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 14

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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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    FPV/RTV  
Total, other (not including serious) adverse events    
# participants affected     63  
Blood and lymphatic system disorders    
Lymphadenopathy † 1  
# participants affected / at risk     4/69 (5.80%)  
Eye disorders    
Conjunctivitis † 1  
# participants affected / at risk     4/69 (5.80%)  
Gastrointestinal disorders    
Vomiting † 1  
# participants affected / at risk     28/69 (40.58%)  
Diarrhoea † 1  
# participants affected / at risk     18/69 (26.09%)  
Nausea † 1  
# participants affected / at risk     16/69 (23.19%)  
Abdominal pain † 1  
# participants affected / at risk     7/69 (10.14%)  
Abdominal pain upper † 1  
# participants affected / at risk     4/69 (5.80%)  
Dental caries † 1  
# participants affected / at risk     4/69 (5.80%)  
General disorders    
Pyrexia † 1  
# participants affected / at risk     10/69 (14.49%)  
Infections and infestations    
Upper respiratory tract infection † 1  
# participants affected / at risk     17/69 (24.64%)  
Bronchitis † 1  
# participants affected / at risk     12/69 (17.39%)  
Nasopharyngitis † 1  
# participants affected / at risk     11/69 (15.94%)  
Otitis media † 1  
# participants affected / at risk     8/69 (11.59%)  
Influenza † 1  
# participants affected / at risk     6/69 (8.70%)  
Oral herpes † 1  
# participants affected / at risk     4/69 (5.80%)  
Pharyngitis † 1  
# participants affected / at risk     4/69 (5.80%)  
Pharyngitis streptococcal † 1  
# participants affected / at risk     4/69 (5.80%)  
Sinusitis † 1  
# participants affected / at risk     4/69 (5.80%)  
Injury, poisoning and procedural complications    
Arthropod bite † 1  
# participants affected / at risk     4/69 (5.80%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Skin papilloma † 1  
# participants affected / at risk     4/69 (5.80%)  
Nervous system disorders    
Headache † 1  
# participants affected / at risk     17/69 (24.64%)  
Respiratory, thoracic and mediastinal disorders    
Cough † 1  
# participants affected / at risk     16/69 (23.19%)  
Nasal congestion † 1  
# participants affected / at risk     6/69 (8.70%)  
Pharyngolaryngeal pain † 1  
# participants affected / at risk     5/69 (7.25%)  
Rhinorrhoea † 1  
# participants affected / at risk     5/69 (7.25%)  
Epistaxis † 1  
# participants affected / at risk     4/69 (5.80%)  
Rhinitis allergic † 1  
# participants affected / at risk     4/69 (5.80%)  
Skin and subcutaneous tissue disorders    
Rash † 1  
# participants affected / at risk     10/69 (14.49%)  
Acne † 1  
# participants affected / at risk     4/69 (5.80%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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:
unchecked 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.
unchecked 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.


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