Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Janice Piatt, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT00762320
First received: September 29, 2008
Last updated: February 5, 2014
Last verified: February 2014
Results First Received: November 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Low dose Kaletra tablets

  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
Patients weighing 15kg and able to swallow pills, currently taking liquid lpv/rtv were recruited from an outpatient pediatric HIV clinic from 4/1/2009 through 1/12/11

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Low Dose Kaletra

Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra

Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg


Participant Flow:   Overall Study
    Low Dose Kaletra  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  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
Low Dose Kaletra

Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra

Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg


Baseline Measures
    Low Dose Kaletra  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     8  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.18  ± 1.79  
Gender  
[units: participants]
 
Female     5  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
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1.  Primary:   Absolute CD4 and CD4 %   [ Time Frame: Baseline, 4 weeks, 12 weeks, 26 weeks ]

Measure Type Primary
Measure Title Absolute CD4 and CD4 %
Measure Description Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.
Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks  
Safety Issue Yes  

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.
All participants were analyzed.

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Absolute CD4 and CD4 %  
[units: participants]
  8  

No statistical analysis provided for Absolute CD4 and CD4 %



2.  Primary:   Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
Measure Description Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.
Time Frame Baseline  
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.
All participants were analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid  
[units: ng/ml]
Median ± Standard Deviation
 
Cmax Lpv     9742  ± 2533.9  
Cmax Rtv     637.0  ± 357.5  

No statistical analysis provided for Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid



3.  Primary:   Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
Measure Description Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.
Time Frame Baseline  
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.
All participants were analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra  
[units: hr*ng/ml]
Median ± Standard Deviation
 
Lpv AUC at baseline     90651  ± 30346.4  
Rtv AUC at baseline     3701.2  ± 2088.0  

No statistical analysis provided for Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra



4.  Primary:   Lopinavir AUC Ratio of Baseline:Week 4   [ Time Frame: Baseline, week 4 ]

Measure Type Primary
Measure Title Lopinavir AUC Ratio of Baseline:Week 4
Measure Description Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.
Time Frame Baseline, week 4  
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.
No text entered.

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Lopinavir AUC Ratio of Baseline:Week 4  
[units: ratio]
Mean ± Standard Deviation
  1.01  ± .36  

No statistical analysis provided for Lopinavir AUC Ratio of Baseline:Week 4



5.  Primary:   Viral Load (VL)   [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]

Measure Type Primary
Measure Title Viral Load (VL)
Measure Description Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study
Time Frame Baseline, Week 4, Week 12 and Week 24  
Safety Issue Yes  

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.
All subjects in study were analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Viral Load (VL)  
[units: participants]
  8  

No statistical analysis provided for Viral Load (VL)



6.  Primary:   Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks   [ Time Frame: 4 weeks ]

Measure Type Primary
Measure Title Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
Measure Description Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs
Time Frame 4 weeks  
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.
All participants were analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks  
[units: ng/ml]
Median ± Standard Deviation
 
Lpv Cmax at 4 weeks     11143  ± 2839.5  
Rtv Cmax at 4 weeks     912.1  ± 588.9  

No statistical analysis provided for Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks



7.  Primary:   Lopinavir and Ritonavir AUC on Low Dose Tablet   [ Time Frame: 4 weeks ]

Measure Type Primary
Measure Title Lopinavir and Ritonavir AUC on Low Dose Tablet
Measure Description Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.
Time Frame 4 weeks  
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.
All participants were analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra Tablets

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Lopinavir and Ritonavir AUC on Low Dose Tablet  
[units: hr*ng/ml]
Median ± Standard Deviation
 
Lpv AUC at 4 weeks     85670  ± 25184.5  
Rtv AUC at 4 weeks     4876.1  ± 2541.0  

No statistical analysis provided for Lopinavir and Ritonavir AUC on Low Dose Tablet



8.  Secondary:   Patient Satisfaction   [ Time Frame: Baseline, 1 month ]

Measure Type Secondary
Measure Title Patient Satisfaction
Measure Description Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.
Time Frame Baseline, 1 month  
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.
Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.

Reporting Groups
  Description
Low Dose Kaletra Baseline Visit Patient satisfaction score at baseline visit
Low Dose Kaletra Week 4 Visit Patient Satisfaction Score at Week 4 visit

Measured Values
    Low Dose Kaletra Baseline Visit     Low Dose Kaletra Week 4 Visit  
Number of Participants Analyzed  
[units: participants]
  5     5  
Patient Satisfaction  
[units: units on a scale]
Mean ± Standard Deviation
  20.2  ± 7.76     21.8  ± 6.02  


Statistical Analysis 1 for Patient Satisfaction
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] =.004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  df=4
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Symptoms Across All Patients   [ Time Frame: Baseline, 1 month, 3 months, 6 months ]

Measure Type Secondary
Measure Title Symptoms Across All Patients
Measure Description Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.
Time Frame Baseline, 1 month, 3 months, 6 months  
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.
All participants analyzed

Reporting Groups
  Description
Low Dose Kaletra Patients receiving Low Dose Kaletra

Measured Values
    Low Dose Kaletra  
Number of Participants Analyzed  
[units: participants]
  8  
Symptoms Across All Patients  
[units: numer of symptoms]
Mean ± Standard Deviation
 
Symptoms for all subjects at Baseline     20.20  ± 7.76  
Symptoms for all subjects at 4 Weeks     21.80  ± 6.02  
Symptoms for all subjects at 12 Weeks     26.40  ± 2.30  
Symptoms for all subjects at 24 weeks     26.60  ± 3.21  

No statistical analysis provided for Symptoms Across All Patients



10.  Secondary:   Parent Satisfaction   [ Time Frame: Baseline, 4 week, 12 weeks and 24 weeks ]

Measure Type Secondary
Measure Title Parent Satisfaction
Measure Description Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.
Time Frame Baseline, 4 week, 12 weeks and 24 weeks  
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.
No text entered.

Reporting Groups
  Description
Low Dose Kaletra Baseline Patients receiving Low Dose Kaletra at baseline
Low Dose Kaletra Week 4 Patients Receiving Low Dose Kaletra at Week 4

Measured Values
    Low Dose Kaletra Baseline     Low Dose Kaletra Week 4  
Number of Participants Analyzed  
[units: participants]
  8     8  
Parent Satisfaction  
[units: Score on a survey]
Mean ± Standard Deviation
  26.75  ± 3.92     28.38  ± 3.02  


Statistical Analysis 1 for Parent Satisfaction
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  df=7
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  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
Early termination leading to small number of subjects analyzed.


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