Medical Advocates

Stavudine
(Zerit)

 
Journal Citations

General Reports
In Vitro Studies
Bioequivalence Studies
Pharmacokinetics
Drug/Drug Interactions
Resistance/Cross-Resistance
Adverse Events
Dosing
Efficacy
Adult/Adolescent Indications
Diagnostics/Monitoring

Therapeutic Strategies


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Last Update:  August 23, 2008
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General Reports
         

 
Safety of stavudine in the treatment of HIV infection with a special focus on resource-limited settings.
Makinson A, Moing VL, Kouanfack C, et al
Expert Opin Drug Saf. 2008 May;7(3):283-93.
Abstract
 
Radiolabeling, pharmacoscintigraphic evaluation and antiretroviral efficacy of stavudine
loaded (99m)Tc labeled galactosylated liposomes.

Garg M, Garg BR, Jain S, et al  
Eur J Pharm Sci. 2008 Feb 2
Abstract
 
Transport of stavudine, delavirdine, and saquinavir across the blood-brain barrier by
polybutylcyanoacrylate, methylmethacrylate-sulfopropylmethacrylate, and solid lipid

nanoparticles.
Kuo YC, Su FL
Int J Pharm
. 2007 Mar 12
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Usage of stavudine (D4T) - a retrospective analysis in a South London hospital.
Lechelt M, McCormick S, de Ruiter A.
Int J STD AIDS. 2007 Mar;18(3):215-7

Abstract


In Vitro Studies
         

  Mitochondrial oxidative stress in human hepatoma cells exposed to stavudine.
Velsor LW, Kovacevic M, Goldstein M, et al
Toxicol Appl Pharmacol. 2004 Aug 15;199(1):10-9.
Abstract

Bioequivalence Studies
         

 
Comparative bioavailability/bioequivalence of two different stavudine 40 mg capsule formulations:
a randomized, 2-way, crossover study in healthy volunteers under fasting condition.

Monif T, Tippabhotla SK, Garg M, Singla AK. 
Int J Clin Pharmacol Ther. 2007 Aug;45(8):469-74
Abstract

Bioequivalence evaluation of two marketed brands of stavudine 40mg capsules in healthy
human South African volunteers.
Narang VS, Lulla A, Malhotra G, Purandare S.
Pharmacol Res. 2004 Nov;50(5):511-6.

Abstract


Pharmacokinetics
         

 
Stavudine-loaded mannosylated liposomes: in-vitro anti-HIV-I activity, tissue distribution and
pharmacokinetics.

Garg M, Asthana A, Agashe HB, et al

J Pharm Pharmacol. 2006 May;58(5):605-1
6.
Abstract
 
Upregulatory Mechanisms Compensate for Mitochondrial DNA Depletion in Asymptomatic
Individuals Receiving Stavudine Plus Didanosine.
Miro O, Lopez S, Rodriguez de la Concepcion M, et al 
J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1550-1555.
Abstract

Lack of Reduction of Thymidine Kinase Activity in Stavudine-Treated HIV-Infected Patients.
Turriziani O, Gianotti N, Bambacioni F, et al   
AIDS Res Hum Retroviruses.
2004 Jul;20(7):701-3.
Abstract

Azidodeoxythymidine and didehydrodeoxythymidine as inhibitors and substrates of the
human  herpesvirus 8thymidine kinase.
 
Lock MJ, Thorley N, Teo J, Emery VC.
J Antimicrob Chemother 2002 Feb;49(2):359-366

Abstract

FULL-TEXT ARTICLE
Pharmacokinetics of single-dose oral stavudine in subjects with renal impairment and in subjects
requiring hemodialysis.
Grasela DM, Stoltz RR, Barry M, et al.
Antimicrob Agents Chemother 2000 Aug;44(8):2149-2153           
Paper

 

Drug/Drug Interactions
         

  FULL-TEXT ARTICLE
A multiple drug interaction study of stavudine with agents for opportunistic infections in
human  |immunodeficiency virus-infected patients.
Piscitelli SC, Kelly G, Walker RE, et al.
Antimicrob Agents Chemother 1999 Mar;43(3):647-650
Paper

FULL-TEXT ARTICLE
Influence of prior exposure to zidovudine on stavudine phosphorylation in vivo and ex vivo.  
Hoggard PG, Sales SD, Phiboonbanakit D,  et al.
Antimicrobial Agents and Chemotherapy, February 2001, p. 577-582, Vol. 45, No. 2

Paper

 

Resistance/Cross Resistance
         

 
An HIV-1 215V mutant shows increased phenotypic resistance to d4T.
Pernas M, López-Galíndez C.
Virus Res
. 2008 May 13.
Abstract
 
Prevalence and risk factors for developing K65R mutations among HIV-1 infected patients who fail
an initial regimen of fixed-dose combination of stavudine, lamivudine, and nevirapine.

Sungkanuparph S, Manosuthi W, Kiertiburanakul S, et al  
J Clin Virol. 2008 Mar 1
Abstract
 
HIV drug resistance after the use of generic fixed-dose combination stavudine/lamivudine/
nevirapine as standard first-line regimen.

Marcelin AG, Jarrousse B, Derache A, et al 
AIDS. 2007 Nov 12;21(17):2341-3.
Abstract
 
Resistance development over 144 weeks in treatment-naive patients receiving tenofovir disoproxil
fumarate or stavudine with lamivudine and efavirenz in Study 903.
Margot NA, Lu B, Cheng A, Miller MD;
HIV Med.
2006 Oct;7(7):442-50.
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Antiviral efficacy and genotypic resistance patterns of combination therapy with stavudine/tenofovir
in highly active antiretroviral therapy experienced patients.
Antinori A, Trotta MP, Nastao P, et al
Antivir Ther. 2006;11(2):233-43
Abstract
 
Primer unblocking by HIV-1 reverse transcriptase and resistance to nucleoside RT inhibitors (NRTIs).
Goldschmidt V, Marquet R.
Int J Biochem Cell Biol. 2004 Sep;36(9):1687-705.
Abstract
 
Rate of Thymidine Analogue Resistance Mutation Accumulation With Zidovudine- or Stavudine-
Based Regimens.
For the Adult ACTG Protocol 306 370 Teams. 
J Acquir Immune Defic Syndr.
2004 Apr 20;36(1):600-603.
Abstract

A Novel Genetic Pathway of Human Immunodeficiency Virus Type 1 Resistance to Stavudine
Mediated by the K65R Mutation.

Garcia-Lerma JG, MacInnes H, Bennett D. et al. 

Virol 2003 May 15;77(10):5685-5693

Abstract

Significant levels of intracellular stavudine triphosphate are found in HIV-infected zidovudine-treated
patients.
Becher F, Pruvost AG, Schlemmer DD, et al.

AIDS
2003 Mar 7;17(4):555-61
Abstract

Thymidine analog and multinucleoside resistance mutations are associated with decreased
phenotypic susceptibility to stavudine in HIV type 1 isolated from zidovudine-naive patients
experiencing viremia on stavudine-containing regimens.
Ross L, Scarsella A, Raffanti S, et al
AIDS Res Hum Retroviruses 2001 Aug10;17(12):1107-1115
Abstract

 

Dosing
         

  A WEEK IN REVIEW FEATURED REPORT
Viral efficacy maintained and safety parameters improved with a reduced dose of stavudine: a pilot study.
Ait-Mohand H, Bonmarchand M, Guiguet M, et al
HIV Med. 2008 Jul 21.
Abstract

Efficacy
         

 
Randomization to once-daily Stavudine extended release/lamivudine/efavirenz versus a more frequent
regimen improves adherence while maintaining viral suppression.
Boyle BA, Jayaweera D, Witt MD, et al 
HIV Clin Trials. 2008 May-Jun;9(3):164-76.
Abstract
 
Tolerability and Effectiveness of First-Line Regimens Combining Nevirapine and Lamivudine
Plus Zidovudine or Stavudine in Cameroon.
Laurent C, Bourgeois A, Mpoudi-Ngolé E, et al
AIDS Res Hum Retroviruses
. 2008 Mar 7
Abstract
 
FULL-TEXT ARTICLE
Poor Efficacy and Tolerability of Stavudine, Didanosine, and Efavirenz-based Regimen in
Treatment-Naive Patients in Senegal.

Canestri A, Sow PS, Vray M, et al
MedGenMed. 2007 Oct 9;9(4):7
Paper
 
Efficacy and safety of a reduced-dose of stavudine in HIV-infected patients under immunological
and virological stable conditions.

Pedrol E, Martín T, Del Pozo MA, et al 
Med Clin
(Barc). 2007 Sep 22;129(10):361-5.
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Systematic review of clinical trials evaluating low doses of stavudine as part of
antiretroviral treatment.

Hill A, Ruxrungtham K, Hanvanich M, et al
Expert Opin Pharmacother. 2007 Apr;8(5):679-88.
Abstract
 
Antiviral efficacy and genotypic resistance patterns of combination therapy with stavudine/tenofovir
in highly active antiretroviral therapy experienced patients.
Antinori A, Trotta MP, Nastao P, ey al
Antivir Ther. 2006;11(2):233-43
Abstract
 
Delivery of Didanosine from enteric-coasted, sustained-release bioadhesive formulation
Deshmukh D, Ravis WR, Betageri GV.
Drug Deliv 2003 Jan-Mar;10(1):47-50
Abstract
 
Granulocyte-macrophage colony-stimulating factor enhances viral load in human brain tissue:
amelioration with stavudine.

Kandanearatchi A, Zuckerman M, Smith M, et al.
AIDS. 2002 Feb 15;16(3):413-420. 
Abstract
 
Failure of stavudine-lamivudine combination therapy in antiretroviral-naive patients with AZT-Like HIV-
1 resistance mutations
.

Sarmati L, Nicastri E, Parisi SG et al.
J Med Virol 2001 Dec;65(4):631-63
Abstract
 

Adult/Adolescent Indications
         

HIV
 
 
A WEEK-IN-REVIEW FEATURED REPORT
Experience with the use of a first-line regimen of stavudine, lamivudine and nevirapine in
patients in the TREAT Asia HIV Observational Database.

Zhou J, Paton N, Ditangco R, et al
HIV Med. 2007 Jan;8(1):8-16.
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Antiviral efficacy and genotypic resistance patterns of combination therapy with stavudine/tenofovir
in highly active antiretroviral therapy experienced patients.
Antinori A, Trotta MP, Nastao P, et al
A
ntivir Ther. 2006;11(2):233-43
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Stavudine, lamivudine and nevirapine combination therapy for treatment of HIV infection and AIDS
in adults.
Siegfried N, Van Deventer P, Mahomed F, Rutherford G. 

Cochrane Database Syst Rev.
2006 Apr 19;(2):CD004535.
Abstract
 
Pharmacokinetic Evaluation and Short-Term Activity of Stavudine, Nevirapine, and Nelfinavir Therapy
in HIV-1-Infected Adults.
Skowron G, Leoung G, Hall DB,et al  
J Acquir Immune Defic Syndr
. 2004 Apr 20;35(4):351-358
Abstract
 
Intermittent Administration of High-Dose Stavudine to  Nucleoside-Experienced Individuals Infected
With HIV-1.

Acosta EP, Balfour Jr HH.
J Acquir Immune Defic Syndr. 2003 Jul 1;33(3):343-348.
Abstract

Antiviral activity of enteric-coated Didanosine, Stavudine, and nelfinavir versus Zidovudine plus
Lamivudine and nelfinavir.

Gathe Jr J, Badaro R, Grimwood A, et al.
J Acquir Immune Defic Syndr 2002 Dec 1;31(4):399-403
Abstract

Modulation of Human Immunodeficiency Virus (HIV)-Specific Immune Response by Using Efavirenz,
Nelfinavir, and Stavudine in a Rescue Therapy Regimen for HIV-Infected, Drug-Experienced Patients.
Trabattoni D, Lo Caputo S, Biasin M, et al.

Clin Diagn Lab Immunol 2002 Sep;9(5):1114-8
Abstract
 
Effectiveness and tolerability of nevirapine, stavudine, and lamivudine in clinical practice.
Yozviak JL, Doerfler E, Woodward WC.
HIV Clin Trials 2001 Nov-Dec;2(6):474-476
Abstract
 

 

HCV
 
  Interferon-Ribavirin in Association with Stavudine Has No Impact on Plasma Human
Immunodeficiency Virus (HIV) Type 1 Level in Patients Coinfected with HIV and Hepatitis C Virus:
A CORIST-ANRS HC1 Trial.
Salmon-Ceron D, Lassalle R, Pruvost A, et al.

Clin Infect Dis
2003 May 15;36(10):1295-304
Abstract

Diagnostics/Monitoring
 

 
A color Doppler ultrasound-based comparative study between stavudine and non-stavudine
regimens in the onset of vascular lesions in HIV-1-positive patients.
Maggi P, Chirianni A, Lillo A, et al
In Vivo.
2008 Jul-Aug;22(4):489-92.
Abstract
 
Determination of abacavir, amprenavir, didanosine, efavirenz, nevirapine, and stavudine concentration
in human plasma by MALDI-TOF/TOF.
Notari S, Mancone C, Alonzi T, et al    
J Chromatogr B Analyt Technol Biomed Life Sc
i. 2008 Jan 16
Abstract
 
Monitoring of didanosine and stavudine intracellular trisphosphorylated anabolite concentrations
in HIV-infected patients.
Becher F, Landman R, Mboup S, et al.

AIDS.
2004 Apr 12;18(2):181-187.
Abstract

Therapeutic Strategies
 

Adherence
 
  Better maintained adherence on switching from twice-daily to once-daily therapy for HIV:
a 24-week randomized trial of treatment simplification using stavudine prolonged-release
capsules.
Portsmouth S, Osorio J, McCormick K, et al 
HIV Med.
2005 May;6(3):185-90.
Abstract

Salvage Therapy

  A randomized trial to investigate the recycling of stavudine and didanosine with and without
hydroxyurea in salvage therapy (RESTART).

Stebbing J, Nelson M, Orkin C, et al.
Antimicrob Chemother
. 2004 Feb 4
Abstract

Lipodystrophy Management
 

  Improvement in lipoatrophy associated with highly active antiretroviral therapy in human i
mmunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine:
the results of the TARHEEL study.
McComsey GA, Ward DJ, Hessenthaler SM, et al.  
Clin Infect Dis.
2004 Jan 15;38(2):263-70
Abstract
 
Discontinuation
 
 
Poor Efficacy and Tolerability of Stavudine, Didanosine, and Efavirenz-based Regimen in
Treatment-Naive Patients in Senegal.

Canestri A, Sow PS, Vray M, et al
MedGenMed. 2007 Oct 9;9(4):7.
Abstract
 
Relation of Stavudine Discontinuation to Anthropometric Changes Among HIV-Infected Women.
Tien PC, Schneider MF, Cole SR, et al
J  Acquir Immune Defic Syndr
. 2006 Nov 2;
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Effects of discontinuing Stavudine or protease inhibitor therapy on human immunodeficiency virus-
related fat redistribution evaluated by dual-energy x-ray absorptiometry.
Tavassoli N, Bagheri H, Sommet A, et al

Pharmacotherapy. 2006 Feb;26(2):154-61
Abstract
 

Drug Failure
 
  Options for a Second-Line Antiretroviral Regimen for HIV Type 1-Infected Patients Whose
Initial Regimen of a Fixed-Dose Combination of Stavudine, Lamivudine, and Nevirapine Fails
.
Sungkanuparph S, Manosuthi W, Kiertiburanakul S, et al
Clin Infect Dis. 2007 Feb 1;44(3):447-52.
Abstract


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