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Trial record 60 of 1429 for:    Area Under Curve AND tablet

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)

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 17, 2008
Results First Submitted Date  ICMJE April 25, 2012
Results First Posted Date  ICMJE July 6, 2012
Last Update Posted Date July 6, 2012
Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2012)
Lopinavir Area Under the Curve (AUC) [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ]
Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Plasma Sampling (3 mL of blood) [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ]
Change History Complete list of historical versions of study NCT00810108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Physical Exam [ Time Frame: each visit ]
  • Clinical Assessment [ Time Frame: each visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lopinavir/Ritonavir (Kaletra) PK in Children
Official Title  ICMJE Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets in Pediatric Patients
Brief Summary The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after taking a dose with tablets swallowed whole.
Detailed Description

By the end of 2005, approximately 2.3 million children worldwide were living with HIV/AIDS.1 At least 660,000 children worldwide have advanced HIV/AIDS and are in dire need of antiretroviral treatment. While many barriers exist to scaling up HIV/AIDS care and treatment globally, access to life-saving treatments for children is increasing. The protease inhibitor, lopinavir/ritonavir (Kaletra®), is recommended as a first-line agent by the World Health Organization and by the US Department of Health and Human Services for the treatment of pediatric patients in resource-limited settings and in the United States.

The prescribing information states that these tablets may not be crushed, broken or chewed, and the manufacturer does not plan to examine the pharmacokinetics of crushed tablets at this time. The company found that the crushed tablets were poorly absorbed in a small pharmacokinetic study in several dogs. While this information has spread through investigators by word-of-mouth, this information has not been published in any forum by the company, and no guidance as to the extent of the decrease in absorption has been provided. However, patients and caregivers are dosing pediatric patients with crushed tablets to overcome some of the limitations of the oral solution. If crushed tablet administration yields significantly lower systemic exposure to lopinavir than whole tablets, then patients using this administration technique will be at higher risk for development of viral resistance and treatment failure. This administration technique must be studied so that providers have evidence to support recommendations about this dose administration strategy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV/AIDS Treatment
  • HIV Infections
Intervention  ICMJE Drug: lopinavir/ritonavir (Kaletra®) tablets
The subject will bring their own prescription of lopinavir/ritonavir. The patient will take a witnessed dose of lopinavir/ritonavir with an 6 ounce glass of cool water (if taken whole) or mixed in 4 ounces of Jell-O brand pudding (if crushed).
Other Name: Kaletra®
Study Arms  ICMJE
  • Experimental: Whole Then Crushed Tablets
    These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
    Intervention: Drug: lopinavir/ritonavir (Kaletra®) tablets
  • Experimental: Crushed Then Whole Tablets
    These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
    Intervention: Drug: lopinavir/ritonavir (Kaletra®) tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented HIV infection
  • Taking lopinavir/ritonavir (Kaletra) tablets at standard pediatric doses for greater than two weeks
  • Concomitant medications and/or natural products, including potentially interacting products, have been stable for greater than two weeks and are not expected to change over the course of the study
  • Ability to understand study procedures and assent to participate
  • Parental or guardian consent
  • Aged 6 - 17 years

Exclusion Criteria:

  • Acute serious medical illness or infection (in the judgment of the investigator)requiring treatment and/or hospitalization within 14 days prior to study entry
  • Pregnancy
  • Concomitant medications/natural products that have been started within past two weeks and/or that will be changed over the course of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00810108
Other Study ID Numbers  ICMJE 10894
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brookie Best, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE American Association of Colleges of Pharmacy
Investigators  ICMJE
Principal Investigator: Brookie Best, PharmD, MAS University of California, San Diego
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP