Lopinavir/Ritonavir (Kaletra) PK in Children

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: American Association of Colleges of Pharmacy
• Treatments: Lopinavir; Ritonavir

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.