CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
lopinavir/ritonavir (Kaletra®) tabletsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00810108
NCT00810108Phase 4Completed
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Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets in Pediatric Patients

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Dec 17, 2008·Updated Jul 6, 2012

In Brief

A Phase 4 clinical trial evaluating lopinavir/ritonavir (Kaletra®) tablets for HIV/AIDS Treatment and HIV Infections. Completed, enrolled 12 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS Treatment, HIV Infections
CountriesUnited States
CollaboratorsAmerican Association of Colleges of Pharmacy

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2008
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.5 years ago

Interventions

lopinavir/ritonavir (Kaletra®) tabletsdrug

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).