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Drug

Stavudine

Established medicine
ClassHuman immunodeficiency virus type 1 reverse transcriptase inhibitorResearchOngoing clinical research
Also known as 2',3'-Didehydro-3'-deoxythimidine, 3'-Deoxy-2'-thymidinene, Estavudina, STAVUDINE (d4T)+6 more

2',3'-Didehydro-3'-deoxythimidine, 3'-Deoxy-2'-thymidinene, Estavudina, STAVUDINE (d4T), STV, Zerit, Sanilvudine, Stavudin, 1-(2,3-Dideoxy-beta-D-glycero-pent-2-enofuranosyl)thymine, Stavudinum.

RxNorm59763ChEMBLCHEMBL991ATCJ05AF04UNIIBO9LE4QFZF
Reverse transcriptase/RNaseH
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

Clinical trial2021-11-05Results posted · ClinicalTrials.gov

A Prospective Randomized Open-Label Clinical Trial to Evaluate the Comparative Efficacy and Safety of a Potent Antiretroviral Treatment Regimen With or Without Hydroxyurea for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion

Clinical trial2021-11-01Withdrawn · ClinicalTrials.gov

A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy

Clinical trial2018-03-14Results posted · ClinicalTrials.gov

Treatment Options for Protease Inhibitor-exposed Children

Clinical trial2017-03-13Results posted · ClinicalTrials.gov

A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1

Clinical trial2015-12-01Completed · ClinicalTrials.gov

Drug Safety Update: Stavudine (Zerit): increased risk of potentially severe adverse effects

Regulatory2014-12-11MHRA

Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Clinical trial2014-09-25Completed · ClinicalTrials.gov

Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With Acute/Early HIV Infection

Clinical trial2013-09-06Completed · ClinicalTrials.gov

A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml

Clinical trial2013-07-29Completed · ClinicalTrials.gov

Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

Clinical trial2013-07-29Completed · ClinicalTrials.gov

Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL

Clinical trial2013-05-21Results posted · ClinicalTrials.gov

"Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country

Clinical trial2011-06-21Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Stavudine
Aliases & brands
2',3'-Didehydro-3'-deoxythimidine3'-Deoxy-2'-thymidineneEstavudinaSTAVUDINE (d4T)STVZeritSanilvudineStavudin1-(2,3-Dideoxy-beta-D-glycero-pent-2-enofuranosyl)thymineStavudinum
RxNorm CUI
59763
ChEMBL ID
CHEMBL991
ATC codes
J05AF04
UNII
BO9LE4QFZF
Primary mechanism
Human immunodeficiency virus type 1 reverse transcriptase inhibitor
Regulatory jurisdictions
mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Reverse transcriptase/RNaseH
pol · Q72547
INHIBITORHuman immunodeficiency virus type 1 reverse transcriptase inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Stavudine (Zerit): increased risk of potentially severe adverse effects
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

115 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
115
registered trials across all phases
LATEST COMPLETION 2017
59
Late-stage (III+)
100
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 115
Phase 113Phase 1 / 22Phase 241Phase 323Phase 412Phase N / A24

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Molecular, Biochemical and Clinical Differences Between Stavudine and Tenofovir, Each Combined With Lamivudine and Efavirenz in South African HIV-infected Patients

TerminatedPH IVUniversity of Witwatersrand, South African=602010

Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL

CompletedPH IVKey trialNational Institutes of Health Clinical Center (CC)n=1,7712008

Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time

CompletedPH IVKirby Instituten=802007

A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy

CompletedPH IVNational Institute of Allergy and Infectious Diseases (NIAID)n=2832007

A Retrospective Study to Compare the 3-Year Antiviral Efficacy of Nevirapine and Efavirenz in Combination With D4t and 3tc in 2NN Patients and of Trizivir Versus Trizivir Plus Nevirapine in CHARM Patients

CompletedPH IVInternational Antiviral Therapy Evaluation Centern=7632007

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy

CompletedPH IIIGilead Sciencesn=972017

A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1

CompletedPH IIIKey trialWillem Daniel Francois Ventern=1,0772015

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

CompletedPH IIIKey trialNational Institute of Allergy and Infectious Diseases (NIAID)n=3,5262015

Treatment Options for Protease Inhibitor-exposed Children

CompletedPH IIIColumbia Universityn=3002014

A Randomized Clinical Trial Assessing Continuous HAART Versus Interrupted HAART in a Resource Poor Clinic

CompletedN/AThe Wistar Instituten=302010

"Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country

CompletedN/ACIPRA SAn=8122009
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.