Lopinavir/Ritonavir (Kaletra) PK in Children
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ClinicalTrials.gov Identifier: NCT00810108 |
Recruitment Status :
Completed
First Posted : December 17, 2008
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
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Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS Treatment HIV Infections | Drug: lopinavir/ritonavir (Kaletra®) tablets | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets in Pediatric Patients |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |
Arm | Intervention/treatment |
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Experimental: Whole Then Crushed Tablets
These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
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Drug: 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).
Other Name: Kaletra® |
Experimental: Crushed Then Whole Tablets
These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
|
Drug: 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).
Other Name: Kaletra® |
- Lopinavir Area Under the Curve (AUC) [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ]Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810108
United States, California | |
University of California, San Diego - Skaggs School of Pharmacy and School of Medicine | |
San Diego, California, United States, 92103 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Brookie Best, PharmD, MAS | University of California, San Diego |
Responsible Party: | Brookie Best, PharmD, MAS, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00810108 |
Other Study ID Numbers: |
10894 |
First Posted: | December 17, 2008 Key Record Dates |
Results First Posted: | July 6, 2012 |
Last Update Posted: | July 6, 2012 |
Last Verified: | June 2012 |
HIV/AIDS pediatrics resource-limited settings lopinavir ritonavir |
Kaletra® antiretroviral treatment crushed tablets treatment experienced |
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |