Trial record 5 of 34 for:    " November 19, 2008":" December 19, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV/AIDS Treatment
HIV Infections
Drug: lopinavir/ritonavir (Kaletra®) tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Lopinavir Area Under the Curve (AUC) [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ] [ Designated as safety issue: No ]
    Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)


Enrollment: 12
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole Then Crushed Tablets
These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
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®
Experimental: Crushed Then Whole Tablets
These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
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®

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810108

Locations
United States, California
University of California, San Diego - Skaggs School of Pharmacy and School of Medicine
San Diego, California, United States, 92103
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
American Association of Colleges of Pharmacy
Investigators
Principal Investigator: Brookie Best, PharmD, MAS University of California, San Diego
  More Information

No publications provided

Responsible Party: Brookie Best, PharmD, MAS, 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
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV/AIDS
pediatrics
resource-limited settings
lopinavir
ritonavir
Kaletra®
antiretroviral treatment
crushed tablets
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014