Retrovir

(Zidovudine)

ApprovedSmall molecule

Zidovudine is used to treat HIV infection and to prevent the transmission of HIV from mother to child during pregnancy and childbirth. It works by slowing down the reproduction of the HIV virus in the body.[2] Retrovir is currently approved and in use across 19 indications[4].[1]

Retrovir is one of 358 small molecule programs targeting Tropical Spastic Paraparesis. It is currently in Approved.

Indications

296

Total Trials

Active Trials

357

Competitors

114

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Tropical Spastic ParaparesisApproved

Primary Biliary CirrhosisApproved

Immunodeficiency DiseaseActive, not recruiting

Viral DiseaseActive, not recruiting

PneumocystosisApproved

Severe Combined ImmunodeficiencyApproved

Hepatitis BActive, not recruiting

Hepatitis CActive, not recruiting

NeutropeniaActive, not recruiting

Cytomegalovirus RetinitisActive, not recruiting

Tropical Spastic ParaparesisApproved

Approved

Primary Biliary CirrhosisApproved

Approved

Immunodeficiency DiseaseApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

PneumocystosisApproved

Approved

Severe Combined ImmunodeficiencyApproved

Approved

Hepatitis BApproved

Active, not recruiting

Hepatitis CApproved

Active, not recruiting

NeutropeniaPreclinical

Active, not recruiting

Cytomegalovirus RetinitisPreclinical

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Retrovir

BBp Consulting, Inc

Approved

19 2

Emtriva

Gilead

Preclinical

1 3

Lamprene

Novartis

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Alfenta

Jazz Pharmaceuticals

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Sirturo

WWim Janssens

Preclinical

1 8

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 9

Reminyl

WWim Janssens

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2029

Phase 2/3Active, not recruiting

Treatment

NCT02369406

Clinical

Trials by Indication[1]

HIV infection22 trials

A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000671·750 enrolled

A Phase I Study of Methotrexate for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000834·30 enrolled

A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000919·900 enrolled

Show 19 more trials

A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Completed· Novartis logo

Novartis·Phase 1·NCT00002006

The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

Completed·PParexel·Phase 2·NCT00002347·225 enrolled

Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00017719·440 enrolled

A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000993

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001035·10 enrolled

A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

Completed· GSK logo

GSK·Phase 2·NCT00002086·256 enrolled

Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01061151·3,747 enrolled

Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00102960·377 enrolled

Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00013520·1,125 enrolled

A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00000652·85 enrolled

A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection

Completed· GSK logo

GSK·Phase 1·NCT00002183·60 enrolled

A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000870·200 enrolled

A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Completed· Novartis logo

Novartis·N/A·NCT00002007

A Prospective Double-Blind Study of Retrovir in Early HIV Infection

Completed· GSK logo

GSK·N/A·NCT00002045

A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001002·12 enrolled

The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

Completed· GSK logo

GSK·N/A·NCT00002290

A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000716·70 enrolled

A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000760·96 enrolled

The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000999·500 enrolled

Effectiveness16 trials

The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00002179·200 enrolled

The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

Completed· GSK logo

GSK·Phase 3·NCT00002436·325 enrolled

Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00006396·1,500 enrolled

Show 13 more trials

The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002371·80 enrolled

The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients

Completed· Gilead logo

Gilead·Phase 1·NCT00002326·20 enrolled

The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System

Completed· GSK logo

GSK·N/A·NCT00002288

The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00002376·540 enrolled

The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001063·200 enrolled

Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00050895·775 enrolled

A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000916·399 enrolled

The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· GSK logo

GSK·Phase 3·NCT00002389·210 enrolled

The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00002324·250 enrolled

The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001075·55 enrolled

The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001057·105 enrolled

The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine

Completed·PPharmacia and Upjohn·N/A·NCT00002312

The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs

Completed· GSK logo

GSK·Phase 3·NCT00002391

Treatment13 trials

Early Infant HIV Treatment in Botswana

Active, not recruiting·HHarvard School of Public Health (HSPH)·Phase 2/3·NCT02369406·67 enrolled

A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

Completed·MMylan Laboratories·Phase 2·NCT00002110·300 enrolled

A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· Roche logo

Roche·Phase 3·NCT00002367·40 enrolled

Show 10 more trials

Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00158405·840 enrolled

Tipranavir 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 Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02249130·18 enrolled

Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

Completed· GSK logo

GSK·N/A·NCT00002063

A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001029·654 enrolled

Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000818·18 enrolled

A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000978·68 enrolled

Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00144157·53 enrolled

Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000885·440 enrolled

Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Unknown status·AAgouron Pharmaceuticals·Phase 4·NCT00005000·200 enrolled

A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000719·96 enrolled

HIV10 trials

A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000696·48 enrolled

A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000841·1,750 enrolled

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001010·72 enrolled

Show 7 more trials

A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 3·NCT00002195·290 enrolled

A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000656·116 enrolled

A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001022·1,200 enrolled

Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients

Unknown status·UUniversity Hospital, Geneva·Phase 2/3·NCT01540240·136 enrolled

A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

Completed· GSK logo

GSK·Phase 3·NCT00002320·320 enrolled

The Effects of Zidovudine on the Blood of HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000965·20 enrolled

A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001085·94 enrolled

Drug9 trials

A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002411

A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

Completed·PPharmacia and Upjohn·N/A·NCT00002400·45 enrolled

Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00014937·240 enrolled

Show 6 more trials

A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002369·200 enrolled

A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

Completed·PPharmacia and Upjohn·N/A·NCT00002401·160 enrolled

Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001045·300 enrolled

A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00002410

A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002168·200 enrolled

A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001095·94 enrolled

69 more indications

Children8 trials

The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000983·400 enrolled

A Study of Azidothymidine in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000982·75 enrolled

A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001032·180 enrolled

Show 5 more trials

When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00234091·300 enrolled

A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001111·35 enrolled

The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000865·32 enrolled

A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001066·740 enrolled

A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000952·60 enrolled

Randomized6 trials

Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000810·120 enrolled

A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000637·819 enrolled

A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

Completed· Roche logo

Roche·Phase 2·NCT00002162·140 enrolled

Show 3 more trials

A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin

Completed·GGenelabs Technologies·Phase 2·NCT00001989

A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00002208·400 enrolled

A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000682·120 enrolled

Kaposi's sarcoma6 trials

A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000725·56 enrolled

A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000994·240 enrolled

A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000694·18 enrolled

Show 3 more trials

A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001113·48 enrolled

A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000681·24 enrolled

A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000987·36 enrolled

Double-blind5 trials

A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Completed·HHEM Research·N/A·NCT00002269

A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·N/A·NCT00002323·60 enrolled

Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy

Completed·IImmunobiology Research Institute·Phase 3·NCT00002109

Show 2 more trials

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000781·1,292 enrolled

A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000770·400 enrolled

Immunodeficiency5 trials

Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01516970·312 enrolled

A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000700·482 enrolled

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00799864·54 enrolled

Show 2 more trials

A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000702·315 enrolled

The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Completed· GSK logo

GSK·N/A·NCT00002001

Pregnant Women5 trials

A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000862·36 enrolled

A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00000751·1,600 enrolled

Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000888·14 enrolled

Show 2 more trials

A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000944·24 enrolled

A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000887·24 enrolled

Lymphoma4 trials

Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000703·45 enrolled

Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00217503·15 enrolled

Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002524·46 enrolled

Show 1 more trial

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Terminated·UUniversity of Miami·Phase 2·NCT01964755·6 enrolled

Combination Therapy3 trials

Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00006617·25 enrolled

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

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT01352715·515 enrolled

Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000695·36 enrolled

Advanced3 trials

Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC

Completed· GSK logo

GSK·N/A·NCT00002020

A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000659·80 enrolled

Antiretroviral Therapy for Advanced HIV Disease in South Africa

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 4·NCT00342355·1,771 enrolled

Efficacy and Safety3 trials

Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00273975·123 enrolled

Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

Completed·GG D Searle·Phase 2·NCT00001993·120 enrolled

The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

Completed· GSK logo

GSK·N/A·NCT00002048

AIDS3 trials

A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

Completed· Pfizer logo

Pfizer·N/A·NCT00002013

Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000711·60 enrolled

The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001024·32 enrolled

Single Dose3 trials

A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00144183·407 enrolled

One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

Completed·IInstitut de Recherche pour le Developpement·Phase 2·NCT00142337·244 enrolled

Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group·Phase 2·NCT00307151·452 enrolled

Hemophilia3 trials

Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000705·24 enrolled

Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00002386·55 enrolled

The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia

Completed·UUniversity of Pittsburgh·N/A·NCT00002276

Clinical Trial2 trials

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

Completed·—·Phase 4·NCT02431975·73 enrolled

A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000718·112 enrolled

HIV-12 trials

A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002378·825 enrolled

A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Completed· Merck & Co. logo

Merck & Co.·N/A·NCT00002155·600 enrolled

Completed·PPharmacia·Phase 2·NCT00002435

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Completed· Roche logo

Roche·Phase 1·NCT00002096·24 enrolled

Tics2 trials

Comparison of the Effect of Tipranavir and Ritonavir or Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Zidovudine in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02249416·60 enrolled

Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000706·12 enrolled

Progressive Multifocal Leukoencephalopathy2 trials

Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001048·90 enrolled

A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection

Completed·UUniversity of Miami·N/A·NCT00002270

LAM2 trials

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000882·300 enrolled

3TC (Lamivudine; GR109714X) Open-Label Program

Completed· GSK logo

GSK·N/A·NCT00002108

Pilot Study2 trials

A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients

Unknown status·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199121

A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00001267·42 enrolled

Fed2 trials

Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00779376·68 enrolled

Bioequivalency Study of Zidovudine Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00601562·52 enrolled

Fasting Conditions2 trials

Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00779233·32 enrolled

Bioequivalency Study of Zidovudine Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602550·52 enrolled

Resistance2 trials

Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00109590·175 enrolled

Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000838·256 enrolled

Tuberculosis2 trials

Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00078247·350 enrolled

Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00004736·44 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000664·26 enrolled

Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

Completed· Gilead logo

Gilead·Phase 3·NCT00528957·97 enrolled

Interaction2 trials

Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000732·10 enrolled

Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000734·10 enrolled

Tolerance2 trials

Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000670·16 enrolled

A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000743·64 enrolled

Adult T-Cell Leukemia/lymphoma2 trials

Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma

Terminated·UUniversity of Miami·Phase 4·NCT00854581·13 enrolled

Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma

Completed·AAIDS Malignancy Consortium·Phase 2·NCT00041327·19 enrolled

CLE1 trial

Nucleosides And Darunavir/Dolutegravir In Africa

Unknown status·MMakerere University·Phase 3·NCT03988452·465 enrolled

Renal Failure1 trial

Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Completed· GSK logo

GSK·N/A·NCT00002047

Intensive Care1 trial

Potent Antiviral Therapy for Critically Ill HIV Infected Patients Admitted to Intensive Care

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00028327·250 enrolled

Acetaminophen1 trial

Evaluation of the Interaction Between Acetaminophen and Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000731·10 enrolled

Pediatric Patients1 trial

A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000662

Lymphadenopathy1 trial

Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000728·20 enrolled

Premature Infants1 trial

A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000855·35 enrolled

Neutropenia1 trial

A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

Completed· Novartis logo

Novartis·N/A·NCT00002263

Immune Deficiency1 trial

A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000701·12 enrolled

Erythropoietin1 trial

A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex

Completed· Amgen logo

Amgen·N/A·NCT00002281·24 enrolled

Treatment Failure1 trial

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000918·300 enrolled

Phase II1 trial

A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

Completed· Roche logo

Roche·Phase 2·NCT00002190·30 enrolled

Hepatitis C1 trial

An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C

Completed· Pfizer logo

Pfizer·Phase 4·NCT00141284·12 enrolled

Efficacy1 trial

Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02181933·2,648 enrolled

Adult1 trial

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·N/A·NCT00608569·529 enrolled

Psoriasis1 trial

A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

Completed· GSK logo

GSK·N/A·NCT00002286

Kidney1 trial

A Study of Zidovudine in HIV-Infected Patients With Kidney Problems

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000685

Granulocyte Colony Stimulating Factor1 trial

An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

Completed· Amgen logo

Amgen·Phase 1·NCT00002255

Immune System1 trial

Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001119·288 enrolled

Liver Disease1 trial

A Study of Zidovudine in HIV-Infected Patients With Liver Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001001·39 enrolled

Prevention1 trial

A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000991·600 enrolled

HIV-1 infection1 trial

A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000823·85 enrolled

Drug Therapy1 trial

Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000923·110 enrolled

Chemotherapy1 trial

The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000723·45 enrolled

Intravenous1 trial

A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine in Patients With AIDS and AIDS-Related Complex

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000976·40 enrolled

Pregnant Woman1 trial

Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana

Completed·—·Phase 4·NCT03088410·495 enrolled

Cytomegalovirus Retinitis1 trial

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Completed· Roche logo

Roche·N/A·NCT00002034·100 enrolled

Malaria1 trial

Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women

Completed·UUniversity of California, San Francisco·Phase 3·NCT00993031·389 enrolled

Neuromuscular Disease1 trial

A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases

Completed· GSK logo

GSK·N/A·NCT00002044

Interleukin1 trial

A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001005·30 enrolled

Liver1 trial

Strategies for Delivering Anti-HIV Therapy in South Africa

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00080522·813 enrolled

Adolescent1 trial

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000814·390 enrolled

Methadone1 trial

Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000800·15 enrolled

Hepatitis B1 trial

Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

Completed·IInternational Antiviral Therapy Evaluation Center·Phase 4·NCT00127959·24 enrolled

Pregnancy1 trial

Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000920·24 enrolled

Cytomegalovirus (CMV)1 trial

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000989·50 enrolled

ESS1 trial

Evaluation of Patients Who Have Not Had Success With Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001025·120 enrolled

Vaccine1 trial

A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000755·168 enrolled

Unspecified1 trial

A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00000628·27 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 19, 1987

RETROVIR

NDA NDA019655

Apr 21, 1987

RETROVIR

NDA NDA019655

Oct 13, 1988

RETROVIR

NDA NDA019655

Mar 6, 1989

RETROVIR

NDA NDA019655

Mar 13, 1989

RETROVIR

NDA NDA019655

Sep 28, 1989

RETROVIR

NDA NDA019910

Jan 12, 1990

RETROVIR

NDA NDA019910

Jan 12, 1990

RETROVIR

NDA NDA019655

Feb 2, 1990

RETROVIR

NDA NDA019951

Mar 2, 1990

RETROVIR

NDA NDA019910

Mar 2, 1990

RETROVIR

NDA NDA019655

Apr 30, 1990

RETROVIR

NDA NDA019655

May 2, 1990

RETROVIR

NDA NDA019655

May 2, 1990

RETROVIR

NDA NDA019910

May 25, 1990

RETROVIR

NDA NDA019910

Aug 7, 1992

RETROVIR

NDA NDA019951

Oct 19, 1992

RETROVIR

NDA NDA019910

Aug 24, 1993

RETROVIR

NDA NDA019655

Aug 24, 1993

RETROVIR

NDA NDA019655

Aug 24, 1993

RETROVIR

NDA NDA019655

Aug 24, 1993

RETROVIR

NDA NDA019910

Aug 8, 1994

RETROVIR

NDA NDA019951

Aug 8, 1994

RETROVIR

NDA NDA019655

Aug 8, 1994

RETROVIR

NDA NDA019910

Aug 8, 1994

RETROVIR

NDA NDA019910

Aug 8, 1994

RETROVIR

NDA NDA019655

Oct 7, 1994

RETROVIR

NDA NDA019910

Oct 7, 1994

RETROVIR

NDA NDA019655

Oct 7, 1994

RETROVIR

NDA NDA019951

Feb 6, 1995

RETROVIR

NDA NDA019655

Feb 6, 1995

RETROVIR

NDA NDA019951

Feb 6, 1995

RETROVIR

NDA NDA019910

Jul 20, 1995

RETROVIR

NDA NDA019910

Jul 20, 1995

RETROVIR

NDA NDA019655

Jul 20, 1995

RETROVIR

NDA NDA019951

Dec 19, 1995

RETROVIR

NDA NDA020518

Mar 22, 1996

RETROVIR

NDA NDA019951

Apr 2, 1996

RETROVIR

NDA NDA019951

Oct 4, 1996

RETROVIR

NDA NDA019910

Oct 4, 1996

RETROVIR

NDA NDA019655

Oct 4, 1996

RETROVIR

NDA NDA019910

Oct 4, 1996

RETROVIR

NDA NDA019655

Aug 18, 1997

RETROVIR

NDA NDA019951

Nov 4, 1997

RETROVIR

NDA NDA019655

Feb 12, 1998

RETROVIR

NDA NDA019951

Feb 25, 1998

RETROVIR

NDA NDA019910

Mar 4, 1998

RETROVIR

NDA NDA019910

Mar 4, 1998

RETROVIR

NDA NDA019951

Mar 4, 1998

RETROVIR

NDA NDA019655

Dec 28, 1998

RETROVIR

NDA NDA019655

Feb 26, 1999

RETROVIR

NDA NDA019910

Feb 26, 1999

RETROVIR

NDA NDA019655

Feb 26, 1999

RETROVIR

NDA NDA019951

Feb 1, 2000

RETROVIR

NDA NDA019951

Feb 1, 2000

RETROVIR

NDA NDA019910

Feb 1, 2000

RETROVIR

NDA NDA019655

Mar 30, 2001

RETROVIR

NDA NDA019655

Mar 30, 2001

RETROVIR

NDA NDA019910

Sep 12, 2001

RETROVIR

NDA NDA019951

Oct 5, 2001

RETROVIR

NDA NDA019655

Oct 5, 2001

RETROVIR

NDA NDA019910

Feb 21, 2002

RETROVIR

NDA NDA019655

Feb 21, 2002

RETROVIR

NDA NDA019910

Feb 21, 2002

RETROVIR

NDA NDA019951

Aug 19, 2002

RETROVIR

NDA NDA019951

Dec 18, 2002

RETROVIR

NDA NDA019655

Dec 18, 2002

RETROVIR

NDA NDA019910

Jul 25, 2003

RETROVIR

NDA NDA019951

Jul 29, 2003

RETROVIR

NDA NDA019951

Oct 15, 2003

RETROVIR

NDA NDA019655

Oct 15, 2003

RETROVIR

NDA NDA019910

May 10, 2006

RETROVIR

NDA NDA019910

May 10, 2006

RETROVIR

NDA NDA019655

Jul 10, 2006

RETROVIR

NDA NDA019951

Nov 15, 2006

RETROVIR

NDA NDA019951

Nov 15, 2006

RETROVIR

NDA NDA019655

Nov 15, 2006

RETROVIR

NDA NDA019910

Sep 19, 2008

RETROVIR

NDA NDA019910

Sep 19, 2008

RETROVIR

NDA NDA019655

Jul 23, 2009

ZIDOVUDINE

NDA NDA022294

Nov 6, 2009

RETROVIR

NDA NDA019655

Nov 6, 2009

RETROVIR

NDA NDA019910

May 17, 2010

RETROVIR

NDA NDA019655

May 17, 2010

RETROVIR

NDA NDA019910

Feb 23, 2011

ZIDOVUDINE

NDA NDA200732

Nov 18, 2011

RETROVIR

NDA NDA019910

Nov 18, 2011

RETROVIR

NDA NDA019951

Nov 18, 2011

RETROVIR

NDA NDA019655

May 31, 2012

RETROVIR

NDA NDA019910

May 31, 2012

RETROVIR

NDA NDA019951

May 31, 2012

RETROVIR

NDA NDA019655

Dec 19, 2013

RETROVIR

NDA NDA019951

Dec 23, 2014

RETROVIR

NDA NDA019655

Dec 23, 2014

RETROVIR

NDA NDA019910

Dec 23, 2014

RETROVIR

NDA NDA019951

Feb 24, 2017

RETROVIR

NDA NDA019655

Feb 24, 2017

RETROVIR

NDA NDA019910

Feb 24, 2017

RETROVIR

NDA NDA019951

Apr 10, 2017

RETROVIR

NDA NDA019951

Apr 10, 2017

RETROVIR

NDA NDA019910

Apr 10, 2017

RETROVIR

NDA NDA019655

Nov 28, 2017

RETROVIR

NDA NDA019951

Nov 28, 2017

RETROVIR

NDA NDA019655

Nov 28, 2017

RETROVIR

NDA NDA019910

Sep 10, 2018

RETROVIR

NDA NDA019655

Sep 10, 2018

RETROVIR

NDA NDA019910

Sep 10, 2018

RETROVIR

NDA NDA019951

Jun 18, 2020

RETROVIR

NDA NDA019655

Jun 18, 2020

RETROVIR

NDA NDA019910

Jun 18, 2020

RETROVIR

NDA NDA019951

Nov 11, 2024

RETROVIR

NDA NDA019951

Nov 11, 2024

RETROVIR

NDA NDA019951

Dec 18, 2024

RETROVIR

NDA NDA019655

Dec 18, 2024

RETROVIR

NDA NDA019910

Sources

References

[1]
ClinicalTrials.gov — 296 trial records for Zidovudine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Retrovir drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Zidovudine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Zidovudine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019655). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bp Consulting, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBp Consulting, Inc

Retrovir

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2029

Trials by Indication[1]

HIV infection22 trials

Effectiveness16 trials

Treatment13 trials

HIV10 trials

Drug9 trials

Children8 trials

Randomized6 trials

Kaposi's sarcoma6 trials

Double-blind5 trials

Immunodeficiency5 trials

Pregnant Women5 trials

Lymphoma4 trials

Combination Therapy3 trials

Advanced3 trials

Efficacy and Safety3 trials

AIDS3 trials

Single Dose3 trials

Hemophilia3 trials

Clinical Trial2 trials

HIV-12 trials

Pneumonia2 trials

Infants2 trials

Oral2 trials

Tics2 trials

Progressive Multifocal Leukoencephalopathy2 trials

LAM2 trials

Pilot Study2 trials

Fed2 trials

Fasting Conditions2 trials

Resistance2 trials

Tuberculosis2 trials

Safety and Efficacy2 trials

Interaction2 trials

Tolerance2 trials

Adult T-Cell Leukemia/lymphoma2 trials

CLE1 trial

Renal Failure1 trial

Intensive Care1 trial

Acetaminophen1 trial

Pediatric Patients1 trial

Lymphadenopathy1 trial

Premature Infants1 trial

Neutropenia1 trial

Immune Deficiency1 trial

Erythropoietin1 trial

Treatment Failure1 trial

Phase II1 trial

Hepatitis C1 trial

Efficacy1 trial

Adult1 trial

Psoriasis1 trial

Kidney1 trial

Granulocyte Colony Stimulating Factor1 trial

Immune System1 trial

Liver Disease1 trial

Prevention1 trial

HIV-1 infection1 trial

Drug Therapy1 trial

Chemotherapy1 trial

Intravenous1 trial

Pregnant Woman1 trial

Cytomegalovirus Retinitis1 trial

Malaria1 trial

Neuromuscular Disease1 trial

Interleukin1 trial

Liver1 trial

Adolescent1 trial

Methadone1 trial

Hepatitis B1 trial

Pregnancy1 trial

Cytomegalovirus (CMV)1 trial

ESS1 trial

Vaccine1 trial

Unspecified1 trial