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Didanosine (Videx)
 
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Last Update:  May 13, 2016
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FDA Updates
 

     Internet Documents
 

  DRUG LABEL UPDATE
 FDA Approves Pediatric Efficacy Supplement for Didanosine Delayed-Release Capsules,
 US FDA
September 29, 2008
News Release

General Reports
 

   Journal Papers, Abstracts, and Commentaries

  Single-dose pharmacokinetics of enteric-coated didanosine in HIV-infected children.
King JR, Nachman S, Yogev R, et al.  
Antivir Ther 2002 Dec;7(4):267-70
 Abstract
   
  Dideoxyinosine in children with symptomatic human immunodeficiency virus infection. 
Butler KM, Husson RN, Balis FM et al.
New England Journal of Medicine 1991; 324 (137-144).
Abstract
   
  Effect of food and pharmacokinetic variability on didanosine systemic exposure in HIV-
infected children.
Pediatric AIDS Clinical Trials Group Protocol 144 Study Team. Stevens RC,
Rodman JH, Yong FH et al. 
AIDS Research and Human Retroviruses 2000; 16(5): 415-421.
Abstract
 
     Conference Reports, Abstracts, and Commentaries
 
 

USE OF DIDANOSINE-EC (DDI-EC) IN HIV-INFECTED CHILDREN
S. Gaur, M. Jones, J. Graf, et al
 (2ND IAS)
 Abstract
Clinical Pharmacology
Bioavailability Adverse Events    
Bioavailability

    Journal Papers, Abstracts, and Commentaries

  FULL-TEXT PDF ARTICLE
Efficacy and safety of stavudine plus didanosine in asymptomatic HIV-infected children
with plasma HIV RNA below 50,000 copies per milliliter.  
 Abreu T, Plaisance K, Rexroad V, et al..
Antimicrob Agents Chemother 2000 May;44(5):1375-1376
 PDF Paper

Adverse Events

    Journal Papers, Abstracts, and Commentaries

 
Noncirrhotic Portal Hypertension in Perinatally HIV-Infected Adolescents Treated with Didanosine-Containing Antiretroviral Regimens in Childhood.
 Scherpbier HJ, Terpstra V, Pajkrt D,  et al 
Pediatr Infect Dis J. 2016 May 10
 Abstract

Risk of cancer in children exposed to didanosine in utero.
 Hleyhel M, Goujon S, Delteil C, et al  
AIDS. 2016 Feb 5.
Abstract

  

Pancreatitis in human immunodeficiency virus-infected children receiving dideoxyinosine.
Butler KM, Venzon D, Henry N et al.
Pediatrics 1993; 91(4): 747-751
 Abstract
   
  Retinal toxicity in human immunodeficiency virus-infected children treated with 2′, 3′-
dideoxyinosine.
Whitcup SM, Butler KM, Caruso R, et al.
American Journal of Ophthalmology 1992; 113(1): 1-7.
Abstract
 
          Conference Reports, Abstracts, and Posters 
 
  Didanosine Lowers Mitochondrial DNA Levels in Peripheral Blood Mononuclear Cells in
HIV-1-infected Children Receiving HAART
A Saitoh, T Fenton, C Alvero, et al
 Abstract
Treatment Indications
Monotherapy DDI/D4T DDI/ZDV DDI/D4T/NFV DDI/3TC/EFC
Monotherapy

    Journal Papers, Abstracts, and Commentaries

 
Didanosine population pharmacokinetics in West African HIV-infected children administered
once daily tablets in relation to efficacy after one year of treatment (ANRS 12103).
 Hirt D, Bardin C, Diagbouga S, Nacro B, et al
Antimicrob Agents Chemother. 2009 Jul 6
 Abstract

Clinical pharmacology of 2′, 3′-dideoxyinosine in human immunodeficiency virus-
infected children.
 Balis FM, Pizzo PA,  Butler KM et al.
Journal of Infectious Disease 1992; 165(1): 99-104.
 Abstract

DDI/D4T

    Journal Papers, Abstracts, and Commentaries

  FULL-TEXT ARTICLE
 Efficacy and safety of stavudine plus didanosine in asymptomatic HIV-infected
children with plasma HIV RNA below 50,000 copies per milliliter.
Mendoza C, Ramos JT, Ciria L, et al. 
HIV Clin Trials 2002 Jan-Feb;3(1):9-16 
Paper
   
  Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human
immunodeficiency virus infection.
Kline MW, Van Dyke RB, Lindsey JC et al. The Pediatric AIDS Clinical Trials Group
327 Team.
Pediatrics 1999; 103(5): e62.
Abstract

DDI/ZDV

      Journal Papers, Abstracts, and Commentaries

 
Pharmacokinetics of Didanosine and Drug Resistance Mutations in Infants Exposed to
Zidovudine During Gestation or Postnatally and Treated With Didanosine or Zidovudine
in the First Three Months of Life.
 Kovacs A, Cowles MK, Britto P, et al
Pediatr Infect Dis J. 2005 Jun;24(6):503-509
 Abstract

Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children.
AIDS Clinical Trials Group (ACTG) Study 152 Team. Englund JA, Baker CJ,
Raskino C et al.
New England Journal of Medicine 1997; 336(24): 1704-1712.
 Abstract

DDI/D4T/NFV

    Journal Papers, Abstracts, and Commentaries

  FULL-TEXT ARTICLE
 Pharmacologic characteristics of indinavir, didanosine, and stavudine in human
immunodeficiency virus-infected children receiving combination therapy.
Fletcher CV,  Brundage RC, Remmel RP, Page LM, et al
Antimicrob Agents Chemother 2000 Apr;44(4):1029-1034
 Paper
 
DDI/3TC/EFV

  Journal Papers, Abstracts, and Commentaries

  Short-Term Virological Efficacy, Immune Reconstitution, Tolerance, and Adherence of Once-Daily Dosing of Didanosine, Lamivudine, and Efavirenz in HIV-1-Infected African Children: ANRS 12103 Burkiname.
Barro M, Some J, Foulongne V, et al   
J Acquir Immune Defic Syndr. 2011 Jul;57 Suppl 1:S44-
 Abstract

Prevalence and outcome of HIV-associated malignancies among children attending
a referral clinic in Kampala, Uganda.
Tukei VJ, Kekitiinwa A, Beasley RP.
AIDS. 2011 Jun 13.
Abstract
 
          Conference Reports, Abstracts, and Posters 
 
  Once-a-day paediatric HAART with DDI+3TC+EFV in West Africa: 24 month virological and
immunological outcomes. ANRS12103/12167 trial
H. Hien, B. Nacro, E. Zouré  
(5th IAS Conference)
 Abstract

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