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Nelfinavir (Viracept)
 
Pediatric Index

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Last Update:  February 25, 2015
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New and Noteworthy
     
September 2014
 
 
Drug Alerts
     
General/Miscellaneous Reports
         

        Journal Papers, Abstracts, and Commentaries

 
Novel nelfinavir mesylate loaded d-α-tocopheryl polyethylene glycol 1000 succinate micelles for enhanced pediatric anti HIV therapy: In vitro characterization and in vivo evaluation.
 Moretton MA, Taira C, Flor S, et al
Colloids Surf B Biointerfaces. 2014 Sep 22
 Abstract

CYP2C19 Genetic Variants Affect Nelfinavir Pharmacokinetics and Virologic Response in HIV-1-
Infected Children Receiving Highly Active Antiretroviral Therapy.
 Saitoh A, Capparelli E, Aweeka F, et al   
J Acquir Immune Defic Syndr. 2009 Nov 3.
Abstract

Maintaining the nelfinavir trough concentration above 0.8 mg/L improves virologic response
in HIV-1-infected children.
 Burger DM, Bergshoeff AS, De Groot R, et al
J Pediatr. 2004 Sep;145(3):403-405.
Abstract

 

Clinical Pharmacology
Pharmacokinetics  Resistance      

Pharmacokinetics

        Journal Papers, Abstracts, and Commentaries

 
Age-related effects on nelfinavir and m8 pharmacokinetics: a population study with 182 children.
 Hirt D, Urien S, Jullien V, Firtion G  
Antimicrob Agents Chemother. 2006 Mar;50(3):910-6.
 Abstract
 
An MDR1-3435 variant is associated with higher plasma nelfinavir levels and more rapid virologic
response in HIV-1 infected children.
 Saitoh A, Singh KK, Powell CA, et al 
AIDS. 2005 Mar 4;19(4):371-380.
 Abstract
 
FULL-TEXT ARTICLE
Nelfinavir Pharmacokinetics in Stable Human Immunodeficiency Virus-Positive Children:
Pediatric AIDS Clinical Trials Group Protocol 377.
Floren LC, Wiznia A, Hayashi S 
Pediatrics. 2003 Sep;112(3):E220-E227
 Abstract
 
Pharmacokinetics and Pharmacodynamics of Nelfinavir Administered Twice or Thrice
Daily to Human Immunodeficiency Virus Type 1-Infected Children.
Gatti G, Castelli-Gattinara G, Cruciani M, et al
Clin Infect Dis 2003 Jun 1;36(11):1476-1482
 Abstract

The Pharmacokinetics of Nelfinavir in HIV-1-Infected Children.
 Van Heeswijk RP, Scherpbier HJ, De Koning LA
Ther Drug Monit 2002 Aug;24(4):487-491
 Abstract

 Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants.
Capparelli EV, Sullivan JL, Mofenson L, et al.
Pediatric Infectious Disease Journal 2001; 20:746-751.
Abstract

  

         Conference Reports, Abstracts, and Posters

  Nelfinavir (NFV) pharmacokinetics (PK) in HIV infected children: who are at risk for subtherapeutic
plasma levels?
AS Bergshoeff, PLA Fraaij, Twills
 (14 IAC )
 Abstract		  

Resistance

            Journal Papers, Abstracts, and Commentaries

 
Alternative, Age. and Viral Load-Related Routes of Nelfinavir Resistance in Human
Immunodeficiency Virus Type1- Infected Children Receiving Koghly Active Antiretroviral Therapy.
 Machado ES, Lambert JS, Afonso AO, et al    
Pediatr Infect Dis J. 2004 Nov;23(11):1057-1059.
 Abstract

Emergence of drug resistance mutations in a group of hiv-infected children taking nelfinavir-
containing regimens.
Fitzgibbon JE, Gaur S, Walsman SM, et al.
AIDS Res Hum Retroviruses 2001 Sep20;17(14):1321-8
 Abstract
 
Viral Dynamics

          Conference Reports, Abstracts, and Posters

  IMPACT OF NELFINAVIR (NFV) AND ITS ACTIVE METABOLITE M8 TROUGH LEVELS (TL) ON
VIROLOGIC RESPONSE FROM PRIMARY HIV-1 VERTICALLY INFECTED CHILDREN TREATED
WITH STAVUDINE (D4T), DIDANOSINE (DDI) AND NFV IN THE PENTA 7 STUDY
A. Compagnucci, Y. Saïdi, A. Faye,  et al
 (2nd  IAS)
Abstract
Monotherapy
         

        Journal Papers, Abstracts, and Commentaries

 
Long-Term Safety and Effectiveness of Ritonavir, Nelfinavir, and Lopinavir/Ritonavir in Antiretroviral-
Experienced HIV-Infected Children.
 Rudin C, Burri M, Shen Y, et al  
Pediatr Infect Dis J. 2008 Mar 27
Abstract

Treatment of human immunodeficiency virus 1-infected infants and children with the protease i
nhibitor nelfinavir mesylate.
Krogstad P, Wiznia A, Luzuriaga K, et al.
 Clinical Infectious Diseases 1999; 28:1109- 1118.
Abstract

         Conference Reports, Abstracts, and Posters

  Pharmacokinetics (PK) of Nelfinavir and Its Metabolite (M8) in HIV-Infected Infants Following
BID TID Administration.
E. Capparelli, J. Sullivan, L. Mofenson et al
 (8 CROI)
Abstract
Combination Therapy
NFV/EFV  NFV/Multiple Combinations      

NFV/EFV

        Journal Papers, Abstracts, and Commentaries
 
  Pharmacokinetics and Pharmacodynamics of Efavirenz and Nelfinavir in HIV-infected Children
Participating in an Area-under-the-curve Controlled Trial.
 Fletcher CV, Brundage RC, Fenton T, et al 
Clin Pharmacol Ther. 2007 Jul 4;
Abstract

     Conference Reports, Abstracts, and Posters

  Pediatric Pharmacologic Characteristics of Efavirenz (EFV) and Nelfinavir (NFV)
Associated with Virologic Response in HIV-Infected Children.
(8 CROI)
Abstract

NFV/Multiple Combinations

        Journal Papers, Abstracts, and Commentaries

 
A WEEK-IN-REVIEW FEATURED REPORT
FULL-TEXT PDF ARTICLE
 Effects of highly active antiretroviral therapy with Nelfinavir in vertically HIV-1 infected
children: 3 years of follow-up.
 Resino S, Larru B, Bellon JM, et al
BMC Infect Dis. 2006 Jul 11;6(1):107
 Paper
 
Long-term Experience With Combination Antiretroviral Therapy That Contains
Nelfinavir for up to 7 Yearsin a Pediatric Cohort.
Scherpbier HJ, Bekker V, van Leth F, et al 
Pediatrics. 2006 Feb 15;
 Abstract

Preliminary experiences with triple therapy with nelfinavir and two reverse transcriptase
inhibitors in previously untreated HIV-infected children.  
 Funk MB, Linde R, Wintergerst U, et al.
AIDS 1999; 13:1653-1658. 
Abstract
   
  Combination nucleoside analog reverse transcriptase inhibitor(s) plus nevirapine, nelfinavir,
or ritonavir in stable antiretroviral therapy- experienced HIV-infected children: week 24
results of a randomized controlled trial--PACTG 377.
Pediatric AIDS Clinical Trials Group 377 Study Team. Wiznia A, Stanley K,
Krogstad P et al.
AIDS Research and Human Retroviruses 2000; 16(12): 1113-1121.
Abstract
   
  Combination therapy with efavirenz, nelfinavir, and nucleoside reverse- transcriptase
inhibitors in children infected with human immunodeficiency virus type 1.
Pediatric AIDS Clinical Trials Group 382 Team. Starr SE, Fletcher CV,
Spector SA et al.
New England Journal of Medicine 1999; 341(25): 1874-1881.
Abstract

        Conference Reports, Abstracts, and Posters
 
Effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1-infected children:
3 years of follow-up
Larrú B., Resino S., Bellón J.M., et al
(XVI International AIDS Conference)
 Abstract
 
Lower scores of nelfinavir metabolite M8 were associated with virological failure at
24 weeks of early antiretroviral therapy in primary HIV-1 vertically infected children
in the Penta 7 study
Compagnucci A., Saïdi Y., Gibb D.M., et al
(3rd IAS)
 Abstract

Virologic Response in PI-Naive HIV Infected Children Treated with Nelfinavir (BID or T
ID)-Containing Regimens: the Role of NFV Trough Concentration
(41ICAAC)
 Abstract
   
  Analysis of HIV-1 Drug Resistance in a Randomized, Controlled Trial of a Combination of 
Nucleoside Analog Reverse Transcriptase (RT) Inhibitors Plus Nevirapine (NVP), Nelfinavir (
NFV), or Ritonavir (RTV) in Stable Antiretroviral Therapy- Experienced HIV-Infected Children.
(8 CROI)
Abstract
 
 
Pharmacokinetics of Saquinavir (SQV) with Nelfinavir (NFV) or Ritonavir  (RTV) in
HIV- Infected
 (8 CROI)
Abstract
 
A Randomized Trial of Combination Therapy with Saquinavir Soft Gelatin Capsules (SQV) in
HIV-Infected Children.
(8 CROI)
Abstract
Drug Failure
     

   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

 

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