Zalcitabine

Overview

A dideoxynucleoside compound in which the 3'-hydroxyl group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of 5' to 3' phosphodiester linkages, which are needed for the elongation of DNA chains, thus resulting in the termination of viral DNA growth. The compound is a potent inhibitor of HIV replication at low concentrations, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal toxic side effect is axonal degeneration resulting in peripheral neuropathy.

Indication

用于与AZT、沙奎那韦、利托那韦、奈非那韦或NNRTIs的三药、四药联合用药治疗人类免疫缺陷病毒(俗称艾滋病)（HIV）感染的成年人和青少年。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3	2001/08/31	NCT00000625	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients	2001/08/31	NCT00001022	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.	2001/08/31	NCT00000704	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
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	2001/08/31	NCT00000682	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT	2001/08/31	NCT00002436	Phase 3	Completed	Glaxo Wellcome
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	2001/08/31	NCT00000653	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
A Study of Dideoxycytidine in HIV-Infected Patients	2001/08/31	NCT00000997	Not Applicable	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment	2001/08/31	NCT00000902	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
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	2001/08/31	NCT00002109	Phase 3	Completed	Immunobiology Research Institute
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.	2001/08/31	NCT00000678	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
HIVID TAB 0.75 MG	Hoffmann-La Roche Limited	01990896	Tablet - Oral	.75 MG	12/31/1992
HIVID TAB 0.375MG	Hoffmann-La Roche Limited	01990918	Tablet - Oral	.375 MG	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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