Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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) ]

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 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description 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)

Serious Adverse Events
    FPV/RTV
Total, serious adverse events   
# participants affected   19 
Blood and lymphatic system disorders   
Anemia † 1   
# participants affected / at risk   1/69 (1.45%) 
General disorders   
Pyrexia † 1   
# participants affected / at risk   2/69 (2.90%) 
Hepatobiliary disorders   
Hepatitis † 1   
# participants affected / at risk   1/69 (1.45%) 
Immune system disorders   
Drug hypersensitivity † 1   
# participants affected / at risk   3/69 (4.35%) 
Infections and infestations   
Measles † 1   
# participants affected / at risk   2/69 (2.90%) 
Appendicitis † 1   
# participants affected / at risk   1/69 (1.45%) 
Gastroenteritis † 1   
# participants affected / at risk   1/69 (1.45%) 
Pneumonia † 1   
# participants affected / at risk   1/69 (1.45%) 
Pneumonia bacterial † 1   
# participants affected / at risk   1/69 (1.45%) 
Injury, poisoning and procedural complications   
Eye penetration † 1   
# participants affected / at risk   1/69 (1.45%) 
Investigations   
Blood alkaline phosphatase increased † 1   
# participants affected / at risk   1/69 (1.45%) 
Metabolism and nutrition disorders   
Hyperglycemia † 1   
# participants affected / at risk   1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign salivary gland neoplasm † 1   
# participants affected / at risk   1/69 (1.45%) 
Nervous system disorders   
Headache † 1   
# participants affected / at risk   1/69 (1.45%) 
Psychiatric disorders   
Aggression † 1   
# participants affected / at risk   1/69 (1.45%) 
Anxiety † 1   
# participants affected / at risk   1/69 (1.45%) 
Bipolar disorder † 1   
# participants affected / at risk   1/69 (1.45%) 
Borderline personality disorder † 1   
# participants affected / at risk   1/69 (1.45%) 
Depression † 1   
# participants affected / at risk   1/69 (1.45%) 
Impulse control disorder † 1   
# participants affected / at risk   1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis † 1   
# participants affected / at risk   1/69 (1.45%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information