This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV/AIDS Treatment
HIV Infections
Intervention: Drug: lopinavir/ritonavir (Kaletra®) tablets

  Participant Flow


  Baseline Characteristics
  Hide 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.
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 
Overall Participants Analyzed 
[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
  Hide 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
  Hide More Information

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
e-mail: brookie@ucsd.edu



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
Study First Received: December 15, 2008
Results First Received: April 25, 2012
Last Updated: June 2, 2012