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
  Show All Outcome Measures

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

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

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 ]

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

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

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

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

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

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

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


  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.


  More Information