Drug

Zidovudine

In clinical development

Emerging researchLate-stage development

Also known as AZT, Azidothymidine, Combivir, Retrovir+5 more

AZT, Azidothymidine, Combivir, Retrovir, Trizivir, ZDV, Lamivudine-Zidovudine, Zidovudina, Zidovudinum.

RxNorm11413 ChEMBLCHEMBL129UNII4B9XT59T7S

Research papers

Active clinical trials

Latest activity

beta

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

Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity

Clinical trial2026-07-08Results expected Q4 2026 · ClinicalTrials.gov

Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)

Clinical trial2026-06-30Results expected Q4 2028 · ClinicalTrials.gov

A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

Clinical trial2026-03-10Results posted · ClinicalTrials.gov

The Tshilo Dikotla Study: Metabolic Outcomes of Children HIV/ARV-Exposed Uninfected in Botswana (MOCHA)

Clinical trial2022-03-31Completed · ClinicalTrials.gov

Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Clinical trial2022-02-11Results posted · ClinicalTrials.gov

A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections

Clinical trial2021-11-04Terminated · ClinicalTrials.gov

A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting

Clinical trial2021-11-02Results posted · ClinicalTrials.gov

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

Clinical trial2020-04-30Completed · ClinicalTrials.gov

International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen

Clinical trial2018-10-12Results posted · ClinicalTrials.gov

Phase II Study of Chemotherapy (Doxorubicin, Methotrexate and Leucovorin) in Combination With Antiviral-Based Therapy (Zidovudine + Hydroxyurea) for AIDS, Immunocompromised, or Immunocompetent Patients With Relapsed or CNS Positive Epstein Barr Virus Associated Lymphoma

Clinical trial2018-06-07Terminated · ClinicalTrials.gov

HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

Clinical trial2017-07-19Results posted · ClinicalTrials.gov

Three postpartum antiretroviral regimens to prevent intrapartum HIV infection.

Research2012-06-01The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name

Zidovudine

Aliases & brands

AZTAzidothymidineCombivirRetrovirTrizivirZDVLamivudine-ZidovudineZidovudinaZidovudinum

RxNorm CUI

11413

ChEMBL ID

CHEMBL129

UNII

4B9XT59T7S

Clinical trials

199 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

199

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

100

Late-stage (III+)

190

Completed

Discontinued

PHASE DISTRIBUTIONn = 199

Early Phase 11Phase 141Phase 257Phase 2 / 31Phase 335Phase 411Phase N / A53

Late-stage studies

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

The Tshilo Dikotla Study: Metabolic Outcomes of Children HIV/ARV-Exposed Uninfected in Botswana (MOCHA)

CompletedPH IVAnn & Robert H Lurie Children's Hospital of Chicagon=4952022

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

CompletedPH IVColumbia Universityn=732020

Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study

CompletedPH IVTufts Universityn=682014

Prospective Study of the Molecular Characteristics of Sensitive and Resistant Disease in Patients With HTLV-I Associated Adult T Cell Leukemia Treated With Zidovudine (AZT) Plus Interferon Alpha-2b

TerminatedPH IVUniversity of Miamin=132011

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

Recent completions

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

A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

CompletedPH IIUniversity of Miamin=152025

The Tshilo Dikotla Study: Metabolic Outcomes of Children HIV/ARV-Exposed Uninfected in Botswana (MOCHA)

CompletedPH IVAnn & Robert H Lurie Children's Hospital of Chicagon=4952022

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

CompletedPH IVColumbia Universityn=732020

A Prospective, Multicenter, Open, Randomized Phase 2a Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen After 24 Weeks of Treatment in ART naïve, Non Subtype B HIV-1 Infected Individuals From Tanzania and Ivory Coast

CompletedPH IIMichael Hoelschern=1202017

Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission

CompletedPH IIInternational Maternal Pediatric Adolescent AIDS Clinical Trials Groupn=4522016

Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

CompletedPH IIIKey trialNational Institute of Allergy and Infectious Diseases (NIAID)n=3,7472016

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Three postpartum antiretroviral regimens to prevent intrapartum HIV infection.

The New England journal of medicine · 2012 · 148 cites