Zerit

(Stavudine)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Stavudine is an antiretroviral medication used to treat HIV infection by helping to slow down the virus's ability to reproduce in the body, usually as part of a combination treatment with other HIV drugs.[2] Zerit is currently approved and in use across 11 indications[4].[1]

Zerit is one of 221 small molecule programs targeting AIDS. It is currently in Approved.

Indications

115

Total Trials

Active Trials

220

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AIDSActive, not recruiting

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-Associated NephropathyApproved

HemophiliaActive, not recruiting

LipodystrophyActive, not recruiting

HIV-1 InfectionActive, not recruiting

Kidney DiseaseActive, not recruiting

AIDS DementiaActive, not recruiting

TuberculosisActive, not recruiting

AIDSPhase 1

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-Associated NephropathyApproved

Approved

HemophiliaApproved

Active, not recruiting

LipodystrophyApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

Kidney DiseasePhase 3

Active, not recruiting

AIDS DementiaPhase 3

Active, not recruiting

TuberculosisPhase 1

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Zerit

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

13 2

Leukine

Sanofi

Phase 3

2 3

Praluent

Regeneron

Phase 3

1 4

Intron a

Merck & Co.

Phase 3

1 5

Sunlenca

Gilead

Phase 3

1 6

PEG-Intron

Megace

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

2 9

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Phase 3

1 10

Buprenorphine/naloxone

Astellas

Phase 3

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

Clinical

Trials by Indication[1]

Effectiveness27 trials

A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000939·150 enrolled

A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000922·1,710 enrolled

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

Show 24 more trials

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

Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients

Completed·PPharmacia and Upjohn·N/A·NCT00002211·160 enrolled

A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

Completed· GSK logo

GSK·Phase 2·NCT00002442

Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

Unknown status· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002241·80 enrolled

Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000901·24 enrolled

The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001087·300 enrolled

The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00002381·24 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

Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Unknown status· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002451·8 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 Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Completed· Gilead logo

Gilead·Phase 2·NCT00002379·100 enrolled

Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment

Unknown status· GSK logo

GSK·Phase 4·NCT00005017·300 enrolled

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00005918·730 enrolled

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

A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001108·6 enrolled

Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001091·200 enrolled

A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

Suspended· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002424·186 enrolled

The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001067·105 enrolled

The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002418·25 enrolled

The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002420·25 enrolled

A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

Completed· Merck & Co. logo

Merck & Co.·N/A·NCT00002430·220 enrolled

Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

Completed·—·Phase 1·NCT00002427·225 enrolled

Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00007202·55 enrolled

A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000896·24 enrolled

Drug17 trials

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

A Study of MKC-442 in Combination With Other Anti-HIV Drugs

Completed·TTriangle Pharmaceuticals·Phase 2·NCT00002412

Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002240

Show 14 more trials

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074581·3,526 enrolled

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 Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002227·60 enrolled

A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 4·NCT00005106·230 enrolled

A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed·WWeill Medical College of Cornell University·N/A·NCT00002407

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

A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002308

A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Unknown status·TTriangle Pharmaceuticals·Phase 3·NCT00006208

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 to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00036452·402 enrolled

A Study to Compare Two Different Anti-HIV Drug Regimens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000924·120 enrolled

A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Suspended·TTriangle Pharmaceuticals·Phase 3·NCT00002362

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

Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002429·500 enrolled

HIV infection13 trials

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

Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00006443·24 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 10 more trials

A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00006154·165 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

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000789·230 enrolled

A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002176

A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002349·40 enrolled

Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000872·55 enrolled

Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00006339

A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002177

Dose Optimisation of Stavudine for the Treatment of HIV Infection

Completed·WWillem Daniel Francois Venter·Phase 3·NCT02670772·1,077 enrolled

Treatment8 trials

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

Treatment Options for Protease Inhibitor-exposed Children

Completed·—·Phase 3·NCT01146873·300 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

Show 5 more trials

A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001084·500 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

Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000940·121 enrolled

Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa

Completed·TThe Wistar Institute·N/A·NCT00100646·30 enrolled

Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities

Completed·CCIPRA SA·N/A·NCT00255840·812 enrolled

HIV7 trials

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 Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002207

A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

Completed· Merck & Co. logo

Merck & Co.·N/A·NCT00002354·540 enrolled

Show 4 more trials

ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

Completed·AAbbott·Phase 1/2·NCT00004578·100 enrolled

A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002307

Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002224·120 enrolled

Study of Anti-HIV Therapy Intensification

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00034086·22 enrolled

31 more indications

Children5 trials

Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000851·198 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

Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00312091·44 enrolled

Show 2 more trials

Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

Unknown status·TTriangle Pharmaceuticals·Phase 2·NCT00017992·100 enrolled

Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001083·240 enrolled

Drug Therapy3 trials

A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

Completed·AAbbott·Phase 3·NCT00004583·660 enrolled

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

A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000902·217 enrolled

Safety and Efficacy3 trials

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

A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient

Completed· Gilead logo

Gilead·Phase 2·NCT00002184·120 enrolled

A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

Completed·NNorthwestern University·Phase 3·NCT00002230·100 enrolled

HIV-12 trials

A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

Completed· Roche logo

Roche·Phase 3·NCT00002374·120 enrolled

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

AIDS2 trials

A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000988·40 enrolled

A Study of d4T in Patients With AIDS or AIDS-Related Complex Who Cannot Take AZT

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000686·35 enrolled

Randomized2 trials

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, 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

Terminated·UUniversity of Witwatersrand, South Africa·Phase 4·NCT01601899·60 enrolled

Hemophilia1 trial

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

Resistance1 trial

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

Pilot Study1 trial

A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001688·25 enrolled

Medication1 trial

A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001122·74 enrolled

Efficacy and Safety1 trial

Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

Unknown status·GGroupe Hospitalier Pitie-Salpetriere·Phase 4·NCT00235222·57 enrolled

Infections1 trial

When to Start Anti-HIV Drugs in Patients With Opportunistic Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00055120·283 enrolled

Chemotherapy1 trial

A Study on the Effect of Chemotherapy Combined With Anti-HIV Drugs in HIV-Positive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000899·10 enrolled

AIDS dementia1 trial

A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002246·20 enrolled

Pregnant Women1 trial

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000878·26 enrolled

Double-blind1 trial

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

Kidney Disease1 trial

A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

Completed· Roche logo

Roche·Phase 3·NCT00002397·24 enrolled

Lipodystrophy1 trial

A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00006190

LAM1 trial

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

HIV-Infected Individuals1 trial

A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000822·46 enrolled

Long-term Follow-up1 trial

2NN & CHARM Long-Term Follow-up Study

Completed·IInternational Antiviral Therapy Evaluation Center·Phase 4·NCT00127972·763 enrolled

Women1 trial

Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

Unknown status·PPPD Development, LP·Phase 3·NCT00006397·200 enrolled

Aging1 trial

A Study of HIV-Disease Development in Aging

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00006144·90 enrolled

Monotherapy1 trial

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000831·280 enrolled

Immune System1 trial

Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00004855·55 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

Tuberculosis1 trial

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

Unspecified1 trial

A Study of Efavirenz in Combination With Stavudine and Didanosine

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002225·60 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 24, 1994

ZERIT

NDA NDA020412

Sep 6, 1996

ZERIT

NDA NDA020413

Dec 31, 2002

ZERIT XR

NDA NDA021453

Sources

References

[1]
ClinicalTrials.gov — 115 trial records for Stavudine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zerit drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Stavudine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Stavudine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021453). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company 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: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Zerit

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Effectiveness27 trials

Drug17 trials

HIV infection13 trials

Treatment8 trials

HIV7 trials

Children5 trials

Drug Therapy3 trials

Safety and Efficacy3 trials

HIV-12 trials

AIDS2 trials

Randomized2 trials

Advanced2 trials

Liver1 trial

Tenofovir1 trial

Hemophilia1 trial

Resistance1 trial

Pilot Study1 trial

Medication1 trial

Efficacy and Safety1 trial

Infections1 trial

Chemotherapy1 trial

AIDS dementia1 trial

Pregnant Women1 trial

Double-blind1 trial

Kidney Disease1 trial

Lipodystrophy1 trial

LAM1 trial

HIV-Infected Individuals1 trial

Long-term Follow-up1 trial

Women1 trial

Aging1 trial

Monotherapy1 trial

Immune System1 trial

Treatment Failure1 trial

Tuberculosis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

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