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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) American Association of Colleges of Pharmacy |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00810108 |
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.
Condition | Intervention | Phase |
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HIV/AIDS Treatment HIV Infections |
Drug: lopinavir/ritonavir (Kaletra®) tablets |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets |
Estimated Enrollment: | 12 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Arm A 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).
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Arm B: Experimental
Arm B subjects will take crushed tablets at Study Visit 1, and whole 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).
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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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brookie Best, PharmD, MAS Clinical Research | 858-246-0007 | brookie@ucsd.edu |
United States, California | |
University of California, San Diego - Skaggs School of Pharmacy and School of Medicine | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Brookie Best, PharmD, MAS Clinical Research | |
Principal Investigator: Brookie Best, PharmD, MAS Clinical Research | |
Principal Investigator: Edmund V. Capparelli, PharmD | |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Natella Rakhmanina, M.D. | |
Principal Investigator: Natella Rakhmanina, M.D. |
Principal Investigator: | Brookie Best, PharmD, MAS Clinical Research | University of California, San Diego |
Responsible Party: | KAI Research, Inc. ( Patti Shugarts ) |
Study ID Numbers: | 10894 |
Study First Received: | December 15, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00810108 History of Changes |
Health Authority: | United States: Federal Government |
HIV/AIDS pediatrics resource-limited settings lopinavir ritonavir |
Kaletra® antiretroviral treatment crushed tablets treatment experienced |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases |
Methamphetamine Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Amphetamine Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |