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Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

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ClinicalTrials.gov Identifier: NCT00762320
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Janice Piatt, Phoenix Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Low dose Kaletra tablets
Enrollment 8

Recruitment Details 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  
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description

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

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description

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

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
8
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
7.18  (1.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Absolute CD4 and CD4 %
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed.
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
2.Primary Outcome
Title Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed
Arm/Group Title Low Dose Kaletra
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Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Median (Standard Deviation)
Unit of Measure: ng/ml
Cmax Lpv 9742  (2533.9)
Cmax Rtv 637.0  (357.5)
3.Primary Outcome
Title Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Median (Standard Deviation)
Unit of Measure: hr*ng/ml
Lpv AUC at baseline 90651  (30346.4)
Rtv AUC at baseline 3701.2  (2088.0)
4.Primary Outcome
Title Lopinavir AUC Ratio of Baseline:Week 4
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ratio
1.01  (.36)
5.Primary Outcome
Title Viral Load (VL)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects in study were analyzed
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
6.Primary Outcome
Title Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Median (Standard Deviation)
Unit of Measure: ng/ml
Lpv Cmax at 4 weeks 11143  (2839.5)
Rtv Cmax at 4 weeks 912.1  (588.9)
7.Primary Outcome
Title Lopinavir and Ritonavir AUC on Low Dose Tablet
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra Tablets
Overall Number of Participants Analyzed 8
Median (Standard Deviation)
Unit of Measure: hr*ng/ml
Lpv AUC at 4 weeks 85670  (25184.5)
Rtv AUC at 4 weeks 4876.1  (2541.0)
8.Secondary Outcome
Title Patient Satisfaction
Hide 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
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Hide Analysis Population Description
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.
Arm/Group Title Low Dose Kaletra Baseline Visit Low Dose Kaletra Week 4 Visit
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Patient satisfaction score at baseline visit
Patient Satisfaction Score at Week 4 visit
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.2  (7.76) 21.8  (6.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Kaletra Baseline Visit, Low Dose Kaletra Week 4 Visit
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.004
Comments [Not Specified]
Method t-test, 2 sided
Comments df=4
9.Secondary Outcome
Title Symptoms Across All Patients
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants analyzed
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description:
Patients receiving Low Dose Kaletra
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: numer of symptoms
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)
10.Secondary Outcome
Title Parent Satisfaction
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Kaletra Baseline Low Dose Kaletra Week 4
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Patients receiving Low Dose Kaletra at baseline
Patients Receiving Low Dose Kaletra at Week 4
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Score on a survey
26.75  (3.92) 28.38  (3.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Kaletra Baseline, Low Dose Kaletra Week 4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments df=7
Time Frame Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Kaletra
Hide Arm/Group Description

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

All-Cause Mortality
Low Dose Kaletra
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Kaletra
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose Kaletra
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Ear and labyrinth disorders   
ear pain   1/8 (12.50%)  1
Gastrointestinal disorders   
anorexia   1/8 (12.50%)  1
vomiting   4/8 (50.00%)  4
nausea   2/8 (25.00%)  3
diarrhea   3/8 (37.50%)  6
General disorders   
Throat Pain   1/8 (12.50%)  4
fever   1/8 (12.50%)  3
headache   1/8 (12.50%)  1
Investigations   
Increased MCV   7/8 (87.50%)  23
Increased Cholesterol   7/8 (87.50%)  24
Increased Triglycerides   2/8 (25.00%)  3
increased amylase   5/8 (62.50%)  8
Increased Monocytes   1/8 (12.50%)  1
Increased WBC   2/8 (25.00%)  2
decreased RBC   4/8 (50.00%)  8
decreased plt   2/8 (25.00%)  2
Increased eosinophils   4/8 (50.00%)  4
decreased neutrophil percent   3/8 (37.50%)  7
decreased ANC   2/8 (25.00%)  4
Increased lymphocyte percent   3/8 (37.50%)  8
increased HCT   1/8 (12.50%)  1
decreased CO2   2/8 (25.00%)  2
increased CO2   1/8 (12.50%)  1
Increased Alk Phos   1/8 (12.50%)  2
Decreased Na+   1/8 (12.50%)  1
Increased K+   1/8 (12.50%)  1
decreased K+   1/8 (12.50%)  1
Increased Creatinine   1/8 (12.50%)  2
Musculoskeletal and connective tissue disorders   
Pain  [1]  1/8 (12.50%)  1
leg pain  [2]  2/8 (25.00%)  7
leg fatigue   1/8 (12.50%)  2
Respiratory, thoracic and mediastinal disorders   
Cough   4/8 (50.00%)  8
nasal congestion   3/8 (37.50%)  8
difficulty breathing   1/8 (12.50%)  1
Indicates events were collected by systematic assessment
[1]
Pain due to previously scheduled orthopedic surgery
[2]
leg cramps or leg pain
Early termination leading to small number of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Laura Clarke-Steffen, PhD, RN
Organization: Phoenix Children's Hospital
Phone: 602-933-0234
Responsible Party: Janice Piatt, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00762320     History of Changes
Other Study ID Numbers: 08-017
First Submitted: September 29, 2008
First Posted: September 30, 2008
Results First Submitted: November 14, 2013
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014