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Stavudine (Zerit)
 
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General Reports                  Therapeutic Strategies
In Vitro Studies
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Bioequivalence Studies
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Drug/Drug Interactions
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 Adverse Events
 Dosing
 Efficacy
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 Diagnostics/Monitoring
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General Reports
         
 
Has the phasing out of stavudine in accordance with changes in WHO guidelines led to a decrease in single-drug substitutions in first-line antiretroviral therapy for HIV in sub-Saharan Africa?
 Brennan AT, Davies MA, Bor J,  et al  
AIDS. 2016 Oct 20.
 Abstract

Naringin improves zidovudine- and stavudine-induced skeletal muscle complications in rats.
Adebiyi OO, Adebiyi OA, Owira P.
Hum Exp Toxicol. 2016 Mar 22. pii: 0960327116638726
 Abstract

Changing utilization of Stavudine (d4T) in HIV-positive people in 2006-2013 in the EuroSIDA study.
Podlekareva D, Grint D, Karpov I, et al
HIV Med. 2015 May 18.
 Abstract

Chronic ethanol use in alcoholic beverages by HIV-infected patients affects the therapeutic window of stavudine, lamivudine and nevirapine during the 9-month follow-up period: using chronic alcohol-use biomarkers.
Bbosa GS, Kyegombe DB, Anokbonggo WW. et al
J Basic Clin Physiol Pharmacol. 2014 Jan 27:1-12.
 Abstract
Myristoylated derivatives of 2´,3´-didehydro-2´,3´dideoxythymidine (stavudine, d4T), bi-functional prodrugs with potent anti-HIV-1 activity and low cytotoxicity.
 Singh RK, Miazga A, Dąbrowska A, L
Antivir Chem Chemother. 2013 Aug 28.
Abstract

Biowaiver monographs for immediate-release solid oral dosage forms: Stavudine.
 Silva AL, Cristofoletti R, Storpirtis S,  et al
J Pharm Sci. 2011 Sep 15.
Abstract

 Solid lipid nanoparticles comprising internal Compritol 888 ATO, tripalmitin and cacao butter for encapsulating and
releasing stavudine, delavirdine and saquinavir.
Kuo YC, Chung CY.
 Colloids Surf B Biointerfaces. 2011
Abstract

Stavudine entrapped lipid nanoparticles for targeting lymphatic HIV reservoirs.
 Shegokar R, Singh KK.
Pharmazie. 2011 Apr;66(4):264-71
 Abstract

Development and Evaluation of Stavudine Loaded Injectable Polymeric Particulate Systems.
Sinha VR, Srivastava S.
 Curr Drug Deliv. 2011 Jan 14
 Abstract

The genetic toxicity effects of lamivudine and stavudine antiretroviral agents.
 Guimarães NN, de Andrade HH, Lehmann M, et al   
Expert Opin Drug Saf. 2010 Apr 9.
 Abstract

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
Safety Studies
         
  Drug safety evaluation profile of stavudine plus lamivudine for HIV-1/AIDS infection.
Mateo MG, Gutierrez MD, Vidal F, Domingo P.
Expert Opin Drug Saf. 2012 Apr 3
 Abstract
Bioequivalence Studies
         
 
A single-dose, randomized, open-label, two-period crossover bioequivalence study comparing a
fixed-dose pediatric combination of lamivudine and stavudine tablet for oral suspension with individual
liquid formulations in healthy adult male volunteers.
 Monif T, Reyar S, Tiwari HK, et al 
Arzneimittelforschung. 2009;59(2):104
 Abstract
 
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):605-16.
 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
         
 
Beta-estradiol attenuates the anti-HIV-1 efficacy of Stavudine (D4T) in primary PBL.
 Zhang M, Huang Q, Huang Y, et al
 Retrovirology. 2008 Sep 22;5(1):82.
Abstract

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
         
 
Antiretroviral resistance at virological failure in the NEAT 001/ANRS 143 trial: raltegravir plus darunavir/ritonavir or tenofovir/emtricitabine plus darunavir/ritonavir as first-line ART.
Lambert-Niclot S, George EC, Pozniak A,  et al
J Antimicrob Chemother. 2016 Apr;71(4):1056-62.
Abstract

Nucleoside reverse transcriptase inhibitor resistance mutations associated with first-line Stavudine-containing antiretroviral therapy: programmatic implications for countries phasing out Stavudine.
Tang MW, Rhee SY, Bertagnolio S,  et al
J Infect Dis. 2013 Jun;207 Suppl 2:S70-7.
Abstract
Rate of Accumulation of Thymidine Analogue Mutations in Patients Continuing to Receive
Virologically Failing Regimens Containing Zidovudine or Stavudine: Implications for
Antiretroviral Therapy Programs in Resource-Limited Settings.
 Cozzi-Lepri A, Phillips AN, Martinez-Picado J,  et al
J Infect Dis. 2009 Jul 15.
Abstract

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
         
 
Low dose versus high dose stavudine for treating people with HIV infection.
 Magula N, Dedicoat M.
 Cochrane Database Syst Rev. 2015 Jan 28;1:CD007497.
 Abstract

Stavudine extended release (once-daily, Bristol-Myers Squibb) for the treatment of HIV/AIDS.
Mateo MG, Gutierrez MD, Vidal F, Domingo P.
Expert Opin Pharmacother. 2013 Mar 20.
 Abstract

FULL-TEXT ARTICLE
 Toxicity Associated with Stavudine Dose Reduction from 40 to 30 mg in First-Line Antiretroviral Therapy  
 Pujades-Rodríguez M,  Dantony E,  Pinoges L, et al
PLoS ONE 6(11): e28112.
 Paper

Bioequivalence of dispersed stavudine: opened versus closed capsule dosing.
 Innes S, Norman J, Smith P, et al
Antivir Ther. 2011;16(7):1131-4.
 Abstract

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
         
 
An antiretroviral regimen containing 6 months of stavudine followed by long-term zidovudine for first-line HIV therapy is optimal in resource-limited settings: a prospective, multicenter study in China.
Li T, Guo F, Li Y,, et al
Chin Med J (Engl). 2014 Jan;127(1):59-65.
 Abstract

FULL-TEXT ARTICLE
 Effectiveness and safety of 30mg versus 40mg stavudine regimens: a cohort study among
HIV-infected adults initiating HAART in South Africa.
Maskew M, Westreich D, Fox MP, et al
J Int AIDS Soc. 2012 Mar 12;15(1):13
 Paper

Effectiveness of fixed-dose combination stavudine, lamivudine and nevirapine (GPO-VIR) for treatment of
naïve HIV patients in Thailand: a 3-year follow-up.
Desakorn V, Karmacharya BM, Thanachartwet V,  et al
Southeast Asian J Trop Med Public Health 2011 Nov;42(6):1414-22.
 Abstract

In silico study supports the efficacy of a reduced dose regimen for stavudine.
Hurwitz SJ, Schinazi RF.
 Antiviral Res. 2011 Aug 22.
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Stavudine or zidovudine in three-drug combination therapy for initial treatment of
HIV infection in antiretroviral-naïve individuals.
 Spaulding A, Rutherford GW, Siegfried N.
Cochrane Database Syst Rev. 2010 Aug 4;8:CD008651
 Abstract

HIV suppression with stavudine 30 mg versus 40mg in adults over 60 kg on antiretroviral therapy
in South Africa
 Hoffmann CJ, Charalambous S, Fielding KL, et al
AIDS. 2009 Jun 1.
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
FULL-TEXT PDF ARTICLE
 Durability of Stavudine, Lamivudine and Nevirapine among Advanced HIV-1 Infected Patients
with/without Prior Co-administration of Rifampicin: A 144-week Prospective Study.
 Manosuthi W, Tantanathip P, Prasithisirikul W, et al 
BMC Infect Dis. 2008 Oct 14;8(1):136.
Paper
 
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
 
 
Simultaneous And Extended Delivery Of Stavudine, Lamivudine And Nevirapine In Fixed Dose Combination Using Sandwiched Osmotic Tablets For Hiv Therapy.
Priya MR, Rajendran NN.
Curr Drug Deliv. 2015 May 6. 
Abstract

CD4(+) T Cell Response to Lamivudine, Stavudine and Nevirapine in Human Immunodeficiency Virus Infected Antiretroviral-Naive Men in Nigeria.
 Sule WF, Sani ES.
Indian J Virol. 2011 Dec;22(2):90-7.
 Abstract

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
 Antivir 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
 		  

 
HIV/TB Coinfection
 
  Tuberculosis Treatment and Risk of Stavudine Substitution in First-Line Antiretroviral Therapy.
 Westreich DJ, Sanne I, Maskew M, et al 
Clin Infect Dis. 2009 Apr 1.
 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 Sci. 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
 
 
Reduced dose of stavudine and lipoatrophy in HIV-infected patients in Cameroon.
 Cournil A, Coudray M, Kouanfack C, et al
Antivir Ther. 2010;15(7):1039-43.
 Abstract

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
 
Neurological Disorders
 
  A WEEK-IN-REVIEW FEATURED REPORT
Benefits and risks of stavudine therapy for HIV-associated neurologic complications in Uganda.
Sacktor N, Nakasujja N, Skolasky RL, et al 
Neurology. 2009 Jan 13;72(2):165-70.
 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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