Lopinavir/Ritonavir (Kaletra) PK in Children

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT00810108
First received: December 15, 2008
Last updated: June 2, 2012
Last verified: June 2012
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV/AIDS Treatment
HIV Infections
Intervention: Drug: lopinavir/ritonavir (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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Whole Then Crushed Tablets These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
Crushed Then Whole Tablets These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.

Participant Flow:   Overall Study
    Whole Then Crushed Tablets     Crushed Then Whole Tablets  
STARTED     6     7  
COMPLETED     5     7  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 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
Whole Then Crushed Tablets These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
Crushed Then Whole Tablets These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
Total Total of all reporting groups

Baseline Measures
    Whole Then Crushed Tablets     Crushed Then Whole Tablets     Total  
Number of Participants  
[units: participants]
  6     7     13  
Age  
[units: participants]
     
<=18 years     6     7     13  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Median ( Full Range )
  12  
  ( 10 to 16 )  
  13  
  ( 12 to 16 )  
  13  
  ( 10 to 16 )  
Gender  
[units: participants]
     
Female     3     4     7  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     6     7     13  



  Outcome Measures

1.  Primary:   Lopinavir Area Under the Curve (AUC)   [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information