Lopinavir/Ritonavir (Kaletra) PK in Children

Completed · Phase 4

Conditions studied: HIV/AIDS Treatment, HIV Infections

In brief

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.

Key facts

Study ID

NCT00810108

Run by

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

People needed

12

Starts

2006-06-01

Expected to finish

2009-05-01

Last updated by the study team

2012-07-06

Who can join

Age: 6 and older, up to 17. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego - Skaggs School of Pharmacy and School of Medicine — San Diego, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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