Pediatric Indications

Medical Advocates
Lopinavir/Ritonavir (Kaletra/Aluvia)

Pediatric Indications: Main Page

New and Noteworthy US Treatment Guidelines
General Reports HIV/TB Coinfection
Formulations
Safety/Pharmacokinetics
Drug/Drug Interactions
Diagnostics/Monitoring
Viral Dynamics
Dosage
Efficacy

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Last Update: October 11, 2008
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New and Noteworthy



October 2008

Evolution of HIV and HCV coinfected children receiving long-term lopinavir/ritonavir-based
antiretroviral therapy.
Larrú B, Resino S, Bellón JM, et al Enferm Infecc Microbiol Clin. 2008 Aug-Sep;26(7):426-9.

General Reports



     News

NEWS RELEASE
New Abbott Kaletra (lopinavir/ritonavir) Lower-Strength Tablet for Pediatric
Use Approved in Europe
Abbott Laboratories |
January 28 , 2008
News Release

NEWS RELEASE
Abbott's Kaletra and Aluvia (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use
Receives Positive Opinion from EMEA
Abbott Laboratories
January 28 , 2008
News Release

NEWS RELEASE
Abbott Receives U.S. Food and Drug Administration Approval for New Lower-
Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Abbott Laboratories
November 12, 2007
News Release

     Conference Reports, Abstracts and Posters

POSTER
A Prospective Evaluation of Pharmacologic, Virologic, and Immunologic
Parameters of Lopinavir/Ritonavir for HIV-1-infected Infants < 6 Months of Age
EG Chadwick, J Rodman, P Palumbo, et al
12th Conference on Retroviruses and Opportunistic Infections
PDF Poster   Abstract

Formulations



     Conference Reports, Abstracts and Posters

POSTER
Lopinavir Pharmacokinetic Maturational Changes and Variability in HIV-infected Infants
Beginning Kaletra Therapy at <6 Weeks of Age
E Capparelli, J Pinto, B Robbins, et al
15 CROI
PDF Poster     Abstract

POSTER
Lopinavir/Ritonavir (LPV/r) 100/25 mg Tablet Developed for Pediatric Use:
Bioequivalence to the LPV/r 200/50 mg Tablet at a Dose of 400/100 mg and
Predicted Dosing Regimens in Children
CE. Klein, YL Chiu, SK Causemaker, et al
11th European AIDS Conference
PDF Poster

Safety/Pharmacokinetics



    Journal Papers, Abstracts, and Commentaries

A WEEK IN REVIEW FEATURED REPORT
Pharmacokinetics of High-Dose Lopinavir/Ritonavir with and without Saquinavir or Non-Nucleoside
Reverse Transcriptase Inhibitors in HIV Infected Pediatric and Adolescent Patients Previously Treated
with Protease Inhibitors - Study PACTG P1038.
Robbins BL, Capparelli EV, Chadwick EG, et al
Antimicrob Agents Chemother. 2008 Jul 14.
Abstract

Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected
children.
van der Lee M, Verweel G, de Groot R, Burger D.
Antivir Ther. 2006;11(4):439-45.
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Safety and Antiviral Response at 12 Months of Lopinavir/Ritonavir Therapy in Human
Immunodeficiency Virus-1-Infected Children Experienced With Three Classes of
Antiretrovirals.
Ramos JT, De Jose MI, Duenas J, et al
Pediatr Infect Dis J. 2005 Oct;24(10):867-873.
Abstract

     Conference Reports, Abstracts and Posters

POSTER
Predicted pharmacokinetics of lopinavir after multiple dose administration of lopinavir/
ritonavir tablet to pediatric patients
W Liu, CE Klein, KC Marsh, et al
8th Int Congress on Drug Therapy in HIV Infection Citations
PDF Poster     Abstract

Pharmacokinetics and Safety of Lopinavir/ritonavir Doses Greater than
300 mg/m²/ in Children and Adolescents with HIV Infection
P Havens, M Frank, B Cuene, et al
11th Conference on Retroviruses and Opportunistic Infections
Abstract

Pharmacokinetics and 24 week safety and efficacy of Lopinavir/ritonavir (LPV/r) BID
or QD as part of ART regimen in naïve children
Rosso R., Di Biagio A., Dentone C, et al
3rd IAS Conference
Abstract

Drug/Drug Interactions



    Journal Papers, Abstracts, and Commentaries

Effect of Rifampicin on Lopinavir Pharmacokinetics in HIV-Infected Children With Tuberculosis.
Ren Y, Nuttall JJ, Egbers C, et al
J Acquir Immune Defic Syndr. 2008 Jan 11
Abstract

Exogenous Cushing Syndrome with Inhaled Fluticasone in a Child Receiving
Lopinavir/Ritonavir.
Bhumbra NA, Sahloff EG, Oehrtman SJ, Horner JM.
Ann Pharmacother. 2007 May 29
Abstract

Increased Dose of Lopinavir/Ritonavir Compensates for Efavirenz-Induced
Drug-Drug Interaction in HIV-1-Infected Children.
Bergshoeff AS, Fraaij PL, Ndagijimana J, et al
J Acquir Immune Defic Syndr. 2005 May 1;39(1):63-68.
Abstract

Diagnostics/Monitoring



     Conference Reports, Abstracts and Posters

A new simple and useful immunoenzymatic test to monitoring adherence and through levels of lopinavir in
HIV-infected children
R. Rosso, F. Miletich, L. Nulvesu, et al
(XVII International AIDS Conference)
Abstract

Effects of lopinavir/ritonavir-based therapy on the lipograms of young children
R. Strehlau , A. Coovadia , T. Meyers
(XVII International AIDS Conference)
Abstract

Therapeutic Drug Monitoring of Lopinavir and Saquinavir in Thai HIV-infected Children
J van der Lugt, T Bunupuradah, P Kosalaraska, et al
(15th CROI)
Abstract

Viral Dynamics



    Journal Papers, Abstracts, and Commentaries

Predictive Factors of Virologic Success in HIV-1-Infected Children Treated With
Lopinavir/Ritonavir.
J Acquir Immune Defic Syndr. 2004 Oct 1;37(2):1269-1275.
Abstract

Dosage



     Label Updates

PDF DOCUMENT
New pediatric dosing information for Kaletra, patients 14 days to 6 months and 12-18 years of age
and update information on coadministration with midazolam ,
US FDA
June 23, 2008
Document

    Journal Papers, Abstracts, and Commentaries

Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice
or once daily administration.
Rosso R, Di Biagio A, Dentone C, et al
J Antimicrob Chemother. 2006 Apr 10;
Abstract

     Conference Reports, Abstracts and Posters

Pharmacokinetics and Safety of Once Daily Versus Twice Daily Lopinavir/Ritonavir in HIV-Infected
Pediatric Patients
C la Porte, R van Heeswijk, CD Mitchell, et al
9th Int. Workshop on Clinical Pharmacology of HIV Therapy
PDF Poster

Recommended Dose of Lopinavir/Ritonavir is Sub-optimal in Protease Inhibitor-experienced
Children
N Rakhmanina, J Van Den Anke, M Van Guilder, et al
15th Conference on Retroviruses and Opportunistic Infections
Abstract

POSTER
6-Month Follow-up of Once-daily Lopinavir/ritonavir in HIV-infected Children
G. Verweel, M.J. van der Lee, DM. Burger, R. de Groot
12th Conference on Retroviruses and Opportunistic Infections
PDF Poster

HIV/HCV Coinfection



     Journal Papers, Abstracts, and Commentaries

Evolution of HIV and HCV coinfected children receiving long-term lopinavir/ritonavir-based
antiretroviral therapy.
Larrú B, Resino S, Bellón JM, et al
Enferm Infecc Microbiol Clin. 2008 Aug-Sep;26(7):426-9.
Abstract

HIV/TB Coinfection



     Journal Papers, Abstracts, and Commentaries

Effect of Rifampicin on Lopinavir Pharmacokinetics in HIV-Infected Children With Tuberculosis.
Ren Y, Nuttall JJ, Egbers C, et al
J Acquir Immune Defic Syndr. 2008 Jan 11
Abstract

     Conference Reports, Abstracts and Posters

Plasma Concentrations of Efavirenz and Lopinavir in Children with and without
Rifampicin-based Anti-TB Treatment
Y Ren, J Nuttall, C Egbers, et al
(14 CROI)
Abstract

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Pediatric Indications: Main Page