Phase 4
Completed N=13
Lopinavir/Ritonavir (Kaletra) PK in Children
HIV/AIDS Treatment · HIV
Source: ClinicalTrials.gov NCT00810108 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Lopinavir Area Under the Curve (AUC) — 144; 92 mg*hr/L — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lopinavir Area Under the Curve (AUC) |
144; 92 | <0.05 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00810108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.