Drug

Lamivudine / zidovudine

In clinical development

Emerging researchLate-stage development

Also known as LamiVUDine, Zidovudine, zidovudine and lamivudine, Lamivudine-Zidovudine+1 more

LamiVUDine, Zidovudine, zidovudine and lamivudine, Lamivudine-Zidovudine, LAMIVUDINE/ZIDOVUDINE.

RxNorm214671

Research papers

Latest activity

beta

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

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

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

Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine

Clinical trial2021-11-04Results posted · ClinicalTrials.gov

Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana

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

Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)

Clinical trial2021-08-05Results posted · ClinicalTrials.gov

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

Clinical trial2020-01-30Results posted · ClinicalTrials.gov

Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PEARLS) Trial

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

Steady-state Pharmacokinetics of Efavirenz (Sustiva/Stocrin) 400 mg Once Daily in the Presence of Rifampicin and Isoniazid (Rifinah or the Local Generics)

Clinical trial2018-01-01Primary completion · ClinicalTrials.gov

Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women

Clinical trial2017-10-05Completed · ClinicalTrials.gov

A Phase II, Randomized, Controlled, Open-Label Trial of Combination Therapy With Nelfinavir (NFV) and Saquinavir (SQV)Sgc With Delavirdine (DLV) or 3TC/ZDV Versus Nelfinavir (NFV) and 3TC/ZDV in Subjects With HIV Infection and > 5,000 HIV RNA Copies/ML

Clinical trial2015-03-09Withdrawn · 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

A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses

Clinical trial2011-03-02Completed · ClinicalTrials.gov

Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV.

Research2006-01-01The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name

Lamivudine / zidovudine

Aliases & brands

LamiVUDineZidovudinezidovudine and lamivudineLamivudine-ZidovudineLAMIVUDINE/ZIDOVUDINE

RxNorm CUI

214671

Clinical trials

43 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

registered trials across all phases

LATEST COMPLETION 2018

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 43

Phase 13Phase 28Phase 315Phase 45Phase N / A12

Late-stage studies

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

CompletedPH IVWestatn=4082018

CompletedPH IVKey trialAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionsn=1,5712010

A Phase IV, Open-Label, Multicenter Study of the Efficacy and Safety of Quadruple Combination Antiretroviral Therapy With Combivir (Lamivudine 150mg/Zidovudine 300mg) BID, Ziagen (Abacavir) 300mg BID, and Sustiva (Efavirenz) 600mg QD for 24 Weeks, Followed by the Triple Nucleoside Combination Tablet (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) BID Plus Sustiva (Efavirenz) 600mg QD for 24 Weeks in HIV-Infected Adults

CompletedPH IVGlaxo Wellcomen=402005

A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

CompletedPH IVGlaxo Wellcomen=2302005

Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)

CompletedPH IVGlaxo Wellcomen=1002005

Recent completions

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

CompletedPH IVWestatn=4082018

Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women

CompletedPH ISt Stephens Aids Trustn=262017

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

Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)

CompletedPH IIIAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionsn=5152014

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=4842011

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=7302010

Research activity

1 papers

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

Most influential

Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV.

The New England journal of medicine · 2006 · 625 cites