Cidofovir

Overview

Cidofovir is an injectable antiviral medication employed in the treatment of cytomegalovirus (CMV) retinitis in patients diagnosed with AIDS. It suppresses CMV replication through selective inhibition of viral DNA synthesis. It was manufactured by Gilead and initially approved by the FDA in 1996, but has since been discontinued.

Background

Indication

用于治疗免疫功能缺陷患者不能耐受更昔洛韦和膦甲酸钠治疗或治疗无效的巨细胞病毒感染。

Associated Conditions

Cytomegalovirus Retinitis
Herpes Simplex Virus
Monkeypox
Variola Major (Smallpox)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males	2019/08/13	NCT04055142	Phase 3	Completed	Hospital Universitari Vall d'Hebron Research Institute
A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.	2016/11/30	NCT02976987	Phase 2	Completed	Brugmann University Hospital
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir	2016/10/13	NCT02931539	Phase 3	Completed	Shire
Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.	2015/10/02	NCT02567149	Phase 2	Withdrawn	University of Minnesota
Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis	2015/09/22	NCT02555800	Phase 2	UNKNOWN	Centro de Investigación en. Enfermedades Infecciosas, Mexico
Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers	2015/08/05	NCT02515877	Phase 1	Completed	Gustave Roussy, Cancer Campus, Grand Paris
A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients	2013/09/19	NCT01946009	Not Applicable	Completed	Fundacion SEIMC-GESIDA
Intravesical Cidofovir for Hemorrhagic Cystitis	2013/03/22	NCT01816646	Phase 1	Completed	M.D. Anderson Cancer Center
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis	2011/02/14	NCT01295645	Phase 2	Active, not recruiting	M.D. Anderson Cancer Center
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions	2009/10/05	NCT00989443	Phase 1	Completed	Mithra Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CIDOFOVIR	Mylan Institutional LLC	67457-210	INTRAVENOUS	75 mg in 1 mL	2/25/2020
Vistide	Gilead Sciences, Inc.	61958-0101	INTRAVENOUS	75 mg in 1 mL	9/24/2013
CIDOFOVIR DIHYDRATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-216	INTRAVENOUS	375 mg in 5 mL	4/21/2021

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
EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vial	287040	Emcure Pharmaceuticals Pty Ltd	Medicine	A	4/4/2018

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