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Lopinavir/Ritonavir (Kaletra/Aluvia)
 
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Last Update:  March 15, 2012
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New and Noteworthy
       
March 2012
 
Journal Citations
 

2012 CROI Citations
 

General Reports
       
    Journal Papers, Abstracts, and Commentaries
 
 
Trough Lopinavir Concentrations in Preterm Human Immunodeficiency Virus-Infected Infants.
 Holgate SL, Rabie H, Smith P, Cotton MF.  
Pediatr Infect Dis J. 2012 Mar 12.
Abstract

Kaletra oral solution: modification of confusing label: packaging. an infant died in France.
[No authors listed]
 Prescrire Int. 2008 Aug;17(96):140.
 Abstract

    Conference Reports, Abstracts and Posters


 
POSTER
 Protease genotypes in children and adolescents failing protease inhibitor (PI) -based antiretroviral
therapy (ART) at the Botswana-Baylor Children's Clinical Centre of Excellence in Gaborone, Botswana
A. Gomila, B. Kirk, M. Tolle. et al
 (6th IAS Conference)
 Poster     Abstract

POSTER
 Effect of Lopinavir/Ritonavir on Lipids in HIV-infected Children
 N Rakhmanina, J van den Anker, M K Scott, et al 
(17th CROI)
PDF Poster     Abstract

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
       
    Journal Papers, Abstracts, and Commentaries
 
  Pharmacokinetics of lopinavir in HIV type-1-infected children taking the new tablet |
formulation once daily.
 van der Flier M, Verweel G, van der Knaap LC, et al 
Antivir Ther. 2008;13(8):1087-90.
 Abstract
 
     Conference Reports, Abstracts and Posters
 
 
Pharmacokinetics of a Novel Formulation, Lopinavir/ritonavir Sprinkles meant for children in Healthy Human Subjects:
A Pilot Study
 J Gogtay, M Gole, A Khanna,  et al
 19 CROI
 Abstract

POSTER
 Neonatal Toxicity of Kaletra Oral Solution—LPV, Ethanol, or Propylene Glycol?
 D Boxwell, K Cao, L Lewis, et al
 18 CROI
 PDF Poster     Abstract

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
 
 
Population pharmacokinetics of lopinavir and ritonavir in combination with rifampicin-based
antitubercular treatment in HIV-infected children.
 Zhang C, McIlleron H, Ren Y, et al
Antivir Ther. 2012;17(1):25-33.
 Abstract

Assessment of Lopinavir Pharmacokinetics With Respect to Developmental Changes in Infants and
the Impact on Weight Band-Based Dosing.
 Nikanjam M, Chadwick EG, Robbins B,  et al
Clin Pharmacol Ther. 2011 Dec 21.
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Pharmacokinetics of Lopinavir/Ritonavir Crushed versus Whole Tablets in Children.
 Best BM, Capparelli EV, Diep H, et al
J Acquir Immune Defic Syndr. 2011 Aug 26
Abstract

CYP3A5, ABCB1, and SLCO1B1 Polymorphisms and Pharmacokinetics and Virologic Outcome of
Lopinavir/Ritonavir in HIV-Infected Children.
 Rakhmanina NY, Neely MN, Van Schaik RH, et al
Ther Drug Monit. 2011 Jul 2.
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
 Population pharmacokinetics of lopinavir in combination with rifampicin-based
antitubercular treatment in HIV-infected South African children.
 Elsherbiny D, Ren Y, McIlleron H, et al  
Eur J Clin Pharmacol. 2010 Jun 16.
Abstract

A WEEK-IN REVIEW FESTERED REPORT
Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for
HIV-infected children: a pilot study of paediatric Lopimune versus the
branded product in healthy adult volunteers.
 de Kanter CT, Colbers EP, Fillekes Q, et al
J Antimicrob Chemother. 2010 Jan 7
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children.
 Puthanakit T, van der Lugt J, Bunupuradah T,et al 
J Antimicrob Chemother. 2009 Sep 2
 Abstract

Pharmacokinetics and tolerability of once- versus twice-daily lopinavir/ritonavir
treatment in HIV-1-infected children.
 la Porte C, van Heeswijk R, Mitchell CD, et al
Antivir Ther. 2009;14(4):603-6
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Population Pharmacokinetics of Lopinavir Predict Suboptimal Therapeutic Concentrations
in Treatment Experienced HIV-infected Children.
 Rakhmanina N, van den Anker J, Baghdassarian A, et al
Antimicrob Agents Chemother. 2009 Mar 2.
 Abstract
 
Pharmacokinetics of lopinavir in HIV type-1-infected children taking the new tablet formulation once daily.
 van der Flier M, Verweel G, van der Knaap LC, et al 
Antivir Ther. 2008;13(8):1087-90.
 Abstract
 
A WEEK IN REVIEW FEATURED REPORT
Steady-State Pharmacokinetics of Lopinavir/Ritonavir in Combination With Efavirenz in
Human Immunodeficiency Virus-Infected Pediatric Patients.
 King JR, Acosta EP, Yogev R, et al 
Pediatr Infect Dis J. 2008 Dec 22
 Abstract
 
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
 
 
Pharmacokinetics of Lopinavir in HIV-1 infected children
 S Hegoburu, C. Hocht, V. Niselman,  et al
 (11th Int Workshop on Clinical Pharmacology  of HIV Therapy)
 PDF Abstract

POSTER
 Pharmacokinetics of Lopinavir/Ritonavir Crushed vs Whole Tablets in Children
H Diep, B Best, E Capparelli. et al
(17th CROI)
PDF Poster     Abstract

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
 
 
Therapeutic Drug Monitoring of Lopinavir in HIV -infected Children Receiving Adult Tablets:
Therapeutic Drug Monitoring of Lopinavir Tablets Given to Children
 Puthanakit T, Chokephaibulkit K, Suntarattiwong P, et al
Pediatr Infect Dis J. 2009 Oct 24.
 Abstract

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
 
 
Predictors of Virologic and Clinical Response to Nevirapine- vs Lopinavir/ritonavir-based ART in Infants and Children with and without Prior Nevirapine Exposure for the PMTCT
 J Lindsey, M Hughes, A Violari, et al
 (19th CROI)
 Abstract

Predictive Factors of Virologic Success in HIV-1-Infected Children Treated With
Lopinavir/Ritonavir.
Delaugerre C, Teglas JP, Treluyer JM,
 J Acquir Immune Defic Syndr. 2004 Oct 1;37(2):1269-1275.
 Abstract
 
     Conference Reports, Abstracts and Posters
 
  Predictors of Virologic and Clinical Response to Nevirapine- vs Lopinavir/ritonavir-based ART in Infants and Children with
and without Prior Nevirapine Exposure for the PMTCT
 J Lindsey, M Hughes, A Violari, et al
 (19th CROI)
 Abstract

Virological and Immunological Responses in Infants Receiving a Lopinavir/Ritonavir
(LPV/r)-based Regimen
 A Violari, M Cotton, T Duong, et al 
(17th CROI)
 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
 
 
How well do the revised World Health Organisation weight-based dosing guidelines for
lopinavir/ritonavir in infants and children correlate with body surface area-based dosing
recommendations?
J. Nuttall, B. Eley, M.-A. Davies, et al
 (5th IAS Conference)
 Abstract

POSTER
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

Resistance
       
     Journal Papers, Abstracts, and Commentaries
 
  Lopinavir/Ritonavir-based Antiretroviral Therapy in Human Immunodeficiency Virus Type
1-infected Naive Children: Rare Protease Inhibitor Resistance Mutations But High
Lamivudine/Emtricitabine Resistance at the Time of Virologic Failure.
Frange P, Briand N, Avettand-Fenoel V,  et al
 Pediatr Infect Dis J. 2011 Mar 21
 Abstract
 
     Conference Reports, Abstracts and Posters
 
  HIV-1 drug resistance patterns in South Africans failing standardized treatment regimens:
a comparison of adult vs. pediatric patients
 T. Rossouw, G. Malherbe, G. van Dyk, et al
(6th IAS Conference)
 Abstract

Treatment Strategies
       
    Journal Papers, Abstracts, and Commentaries
 
 

A WEEK-IN-REVIEW FEATURED REPORT
Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in
virologically suppressed children.
 Bunupuradah T, Kosalaraksa P, Puthanakit T, et al
AIDS. 2010 Dec 13.
 Abstract

     Conference Reports, Abstracts and Posters
 
 

POSTER
 Clinical outcomes, immmunologic function and virologic suppression among HIV infected children
receiving Lopinavir/ritonavir-based second line antiretroviral therapy at National Pediatric Hospital,
Phnom Penh, Cambodia
 S. Sophan, E. Nerrienet, U. Vibol, et al
(XVIII IAS Conference
 PDF Poster     Abstract

Lopinavir/ritonavir-based second line antiretroviral treatment in children at National Pediatric
Hospital, Phnom Penh, Cambodia
S. Sophan.  U. Vibol, H. Chantheany, et al
 (5th IAS Conference)
 Abstract

Simplifying antiretroviral treatment in virally suppressed children by switching from
double boosted protease inhibitors to lopinavir/ritonavir monotherapy
T. Bunupuradah, P. Lumbiganon, T. Puthanakit, et al
 (5th IAS Conference)
 Abstract

Changes in lipid profiles after switching young children from a suppressive lopinavir/ritonavir-based
regimen to a nevirapine-based regimen
R. Strehlau, A. Coovadia, L. Martens, et al
(5th IAS Conference)
 Abstract

To overdose or underdose? The question of Kaletra in children in the UK/Irish Collaborative HIV
Paediatric Study(CHIPS)
 AS Walker, KL Boyd, K Doerholt, et al
(Ninth International Congress on Drug Therapy in HIV Infection)
PDF Abstract

Adverse Events
       
     Journal Papers, Abstracts, and Commentaries
 
  Association between Lipodystrophy and Leptin in HIV -1-Infected Children Receiving
Lopinavir/Ritonavir-Based Therapy
 Resino S, Palladino C, Lorente R, et al 
Pediatr Infect Dis J. 2010 Apr 2.
Abstract

     Conference Reports, Abstracts and Posters

  POSTER
 High Rate of Neutropenia in Young Children Receiving Concomitant Rifabutin and Lopinavir/ritonavir
 H Moultrie, H McIlleron, S Sawry, et al
 (19 CROI)
 PDF Poster    Abstract

HIV/HCV Coinfection
       
     Journal Papers, Abstracts, and Commentaries
 
 
Population pharmacokinetics of lopinavir in combination with rifampicin-based
antitubercular treatment in HIV-infected South African children.
 Elsherbiny D, Ren Y, McIlleron H, et al  
 Eur J Clin Pharmacol. 2010 Jun 16.
Abstract

A WEEK IN REVIEW FEATURED REPORT
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
 
 
Population pharmacokinetics of lopinavir and ritonavir in combination with rifampicin-based
antitubercular treatment in HIV-infected children.
Zhang C, McIlleron H, Ren Y, et al
Antivir Ther. 2012;17(1):25-33.
 Abstract

Pharmacokinetics of Nevirapine in Human Immune Deficiency Virus and Tuberculosis Co-infected Children
Receiving Antiretroviral Fixed-Dose Combination Tablets While Receiving Rifampicin-Containing Tuberculosis
Treatment and after Rifampicin Discontinuation.
 Prasitsuebsai W, Cressey TR, Capparelli E,  et al
Pediatr Infect Dis J. 2011 Dec 2
 Abstract

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
 
  High Rate of Neutropenia in Young Children Receiving Concomitant Rifabutin and Lopinavir/ritonavir
 H Moultrie, H McIlleron, S Sawry, et al
 (19th CROI)
 Abstract

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

HIV/Malaria Coinfection
       
     Conference Reports, Abstracts and Posters
 
  Significant Reduction in Risk of Malaria among HIV+ Children Receiving Lopinavir/ritonavir-based ART Compared to
NNRTI-based ART, a Randomized Open-label Trial
 J Achan, A Kahuru, G Ikilezi, et al
(19th CROI)
 Abstract

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