Hivid

(Zalcitabine)

ApprovedSmall molecule

Hivid is a small molecule that works as a Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Hivid is one of 170 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

169

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HemophiliaActive, not recruiting

ImmunodeficiencyActive, not recruiting

Progressive Multifocal LeukoencephalopathyActive, not recruiting

HIV InfectionPhase 3

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HemophiliaApproved

Active, not recruiting

ImmunodeficiencyPreclinical

Active, not recruiting

Progressive Multifocal LeukoencephalopathyPhase 2

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Hivid

CConrado Roberto Hoffmann Filho

Approved

9 2

Leukine

Sanofi

Phase 3

2 3

Intron a

Merck & Co.

Phase 3

1 4

Sunlenca

Gilead

Phase 3

1 5

Praluent

Regeneron

Phase 3

1 6

PEG-Intron

Merck & Co.

Phase 3

—7

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

3 8

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]

HIV infection9 trials

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000653·140 enrolled

An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies

Completed· Roche logo

Roche·N/A·NCT00002118·600 enrolled

A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000754·60 enrolled

Show 6 more trials

A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000651·750 enrolled

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

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

A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

Completed· Roche logo

Roche·Phase 2·NCT00002333·900 enrolled

A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

Completed· Roche logo

Roche·Phase 3·NCT00002117·528 enrolled

Treatment6 trials

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

Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease

Completed· Roche logo

Roche·N/A·NCT00002081

A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

Completed· Roche logo

Roche·Phase 3·NCT00002334·3,000 enrolled

Show 3 more trials

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

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

Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.

Completed· Roche logo

Roche·N/A·NCT00002256

Double-blind3 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

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

(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000679·600 enrolled

Randomized3 trials

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

Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000678·320 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

Clinical Trial2 trials

A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000704·64 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

14 more indications

HIV2 trials

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

A Study of Dideoxycytidine in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000997·12 enrolled

Effectiveness2 trials

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

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

Tolerance1 trial

An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492

Completed· Roche logo

Roche·Phase 2·NCT00002265

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

Immunodeficiency1 trial

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

Prospective1 trial

A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000969·400 enrolled

Advanced1 trial

A Study of ddC in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Have Not Had Success With Zidovudine (AZT)

Completed· Roche logo

Roche·N/A·NCT00002279

Completed· Roche logo

Roche·Phase 2·NCT00001040·300 enrolled

Concentration1 trial

A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000753·30 enrolled

Drug Therapy1 trial

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

Regulatory

FDA Approval Timeline[4]

Jun 19, 1992

HIVID

NDA NDA020199

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Zalcitabine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zalcitabine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zalcitabine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020199). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

Hivid

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

HIV infection9 trials

Treatment6 trials

Double-blind3 trials

Randomized3 trials

Clinical Trial2 trials

HIV2 trials

Effectiveness2 trials

Tolerance1 trial

Hemophilia1 trial

Immunodeficiency1 trial

Prospective1 trial

Advanced1 trial

Children1 trial

Progressive Multifocal Leukoencephalopathy1 trial

Kaposi's sarcoma1 trial

Combination Therapy1 trial

MPA1 trial

Concentration1 trial

Drug Therapy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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