Lopinavir/Ritonavir (Kaletra) PK in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810108
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
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

  Participant Flow

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 6   7   13 
[Units: Participants]
<=18 years   6   7   13 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Median (Full Range)
 (10 to 16) 
 (12 to 16) 
 (10 to 16) 
[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

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
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.

  More Information