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Lopinavir/Ritonavir (Kaletra) PK in Children

NCT ID: NCT00810108

Last Updated: 2012-07-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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HIV/AIDS Treatment HIV Infections

Keywords

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HIV/AIDS pediatrics resource-limited settings lopinavir ritonavir Kaletra® antiretroviral treatment crushed tablets treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whole Then Crushed Tablets

These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.

Group Type EXPERIMENTAL

lopinavir/ritonavir (Kaletra®) tablets

Intervention Type DRUG

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).

Crushed Then Whole Tablets

These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.

Group Type EXPERIMENTAL

lopinavir/ritonavir (Kaletra®) tablets

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Kaletra®

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Association of Colleges of Pharmacy

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

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Brookie Best

PharmD, MAS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brookie Best, PharmD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego - Skaggs School of Pharmacy and School of Medicine

San Diego, California, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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10894

Identifier Type: -

Identifier Source: org_study_id