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Trial record 5 of 19 for:    " December 10, 2008":" January 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Lopinavir/Ritonavir (Kaletra) PK in Children

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ClinicalTrials.gov Identifier: NCT00810108
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Sponsor:
Collaborator:
American Association of Colleges of Pharmacy
Information provided by (Responsible Party):
Brookie Best, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV/AIDS Treatment
HIV Infections
Intervention Drug: lopinavir/ritonavir (Kaletra®) tablets
Enrollment 12
Recruitment Details Subjects were recruited between August 2008 to August 2009 from the Special Immunology Program at Children' National Medical Center in Washington DC.
Pre-assignment Details  
Arm/Group Title Whole Then Crushed Tablets Crushed Then Whole Tablets
Hide Arm/Group Description These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
Period Title: Overall Study
Started 6 7
Completed 5 7
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Whole Then Crushed Tablets Crushed Then Whole Tablets Total
Hide Arm/Group Description These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2. Total of all reporting groups
Overall Number of Baseline Participants 6 7 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
<=18 years
6
 100.0%
7
 100.0%
13
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 13 participants
12
(10 to 16)
13
(12 to 16)
13
(10 to 16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
Female
3
  50.0%
4
  57.1%
7
  53.8%
Male
3
  50.0%
3
  42.9%
6
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 13 participants
6 7 13
1.Primary Outcome
Title Lopinavir Area Under the Curve (AUC)
Hide Description Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)
Time Frame pre-dose, 1,2,4,6,8, and 12 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed
Arm/Group Title All Subjects Taking Whole Tablets All Subjects Taking Crushed Tablets
Hide Arm/Group Description:
Lopinavir AUC from all subjects taking the whole tablet
Lopinavir AUC from all subjects taking the crushed tablet
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: mg*hr/L
144
(101 to 202)
92
(79 to 103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Subjects Taking Whole Tablets, All Subjects Taking Crushed Tablets
Comments Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Crushed/Whole Tablet AUC
Estimated Value 0.55
Confidence Interval (2-Sided) 90%
0.45 to 0.69
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description Data from all subjects combined
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%)
Total   0/13 (0.00%) 
The AUC of the crushed tablet administration were measured after a single dose only, rather than at steady-state; variable adherence may have impacted results.
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: Dr. Brookie M. Best, Associate Professor
Organization: University of California San Diego
Phone: 858-822-5550
Responsible Party: Brookie Best, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00810108     History of Changes
Other Study ID Numbers: 10894
First Submitted: December 15, 2008
First Posted: December 17, 2008
Results First Submitted: April 25, 2012
Results First Posted: July 6, 2012
Last Update Posted: July 6, 2012