Ganciclovir

Generic Name: Ganciclovir

Brand Names: Cytovene, Zirgan

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₃N_₅O_₄

CAS Number: 82410-32-0

Unique Ingredient Identifier: P9G3CKZ4P5

Background: An acyclovir analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.

Indication: For induction and maintenance in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Also used in the treatment of severe cytomegalovirus (CMV) disease, including CMV pneumonia, CMV gastrointestinal disease, and disseminated CMV infections, in immunocompromised patients.

Associated Conditions: CMV colitis, Cytomegalovirus (CMV) Infections, Cytomegalovirus Retinitis, Cytomegalovirus gastroesophagitis, Varicella-zoster Progressive outer retinal necrosis, Acute Herpetic keratitis, Cytomegalovirus neurological disease, Varicella-zoster virus acute retinal necrosis

Clinical Trials

A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

Not Applicable

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 150

Registration Number: NCT00002257

Locations: 🇨🇦
Saint Paul's Hosp, Vancouver, British Columbia, Canada
🇺🇸
New York Univ Med Ctr, New York, New York, United States
🇺🇸
Beth Israel Deaconess Med Ctr, Boston, Massachusetts, United States

and more 10 locations

A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Not Applicable

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Roche Global Development

Target Recruit Count: 280

Registration Number: NCT00002330

Locations: 🇺🇸
Dr Ken Fisher, Phoenix, Arizona, United States
🇺🇸
Dr Daniel Barbero, Fort Worth, Texas, United States
🇺🇸
Saint Luke's - Roosevelt Hosp Ctr, New York, New York, United States

and more 33 locations

Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

Not Applicable

Completed

Conditions: Cytomegalovirus Infections
Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Hoffmann-La Roche

Registration Number: NCT00002025

Locations: 🇺🇸
Roche Global Development - Palo Alto, Palo Alto, California, United States

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

Phase 1

Completed

Conditions: Cytomegalovirus Infections
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 24

Registration Number: NCT00002096

Locations: 🇺🇸
Georgetown Univ Med Ctr, Washington, District of Columbia, United States
🇺🇸
Ctr for Special Immunology, Irvine, California, United States
🇺🇸
Univ TX Galveston Med Branch, Galveston, Texas, United States

A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

Not Applicable

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Roche Global Development

Target Recruit Count: 450

Registration Number: NCT00002134

Locations: 🇺🇸
Saint Clare's Prof Office, New York, New York, United States
🇺🇸
Dr Neil Brourman, Beverly Hills, California, United States
🇺🇸
Santa Clara Valley Med Ctr, San Jose, California, United States

and more 20 locations

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

Not Applicable

Completed

Conditions: HIV Infections
Cytomegalovirus Retinitis

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 50

Registration Number: NCT00000989

Locations: 🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States
🇺🇸
Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States

and more 1 locations

A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

Phase 1

Withdrawn

Conditions: Encephalopathy
Radiculitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-29

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Registration Number: NCT00000856

A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Phase 1

Completed

Conditions: Cytomegalovirus Infections
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-03

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 32

Registration Number: NCT00000805

Locations: 🇺🇸
Columbia IMPAACT CRS, New York, New York, United States
🇺🇸
Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana, United States
🇺🇸
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California, United States

and more 16 locations

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component

Not Applicable

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2011-03-14

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 240

Registration Number: NCT00000665

Locations: 🇺🇸
UCLA - Jules Stein Eye Institute / SOCA, Los Angeles, California, United States
🇺🇸
Northwestern Univ / SOCA, Chicago, Illinois, United States
🇺🇸
UCSD - Shiley Eye Ctr / SOCA, La Jolla, California, United States

and more 6 locations

Pediatric Kidney Transplant Without Calcineurin Inhibitors

Not Applicable

Completed

Conditions: End-Stage Renal Disease

Interventions: Drug: Daclizumab
Drug: Methylprednisolone/prednisone
Drug: Mycophenolate mofetil
Drug: Sirolimus
Drug: Bactrim
Drug: Ganciclovir
Drug: Lipitor

First Posted Date: 2001-08-31

Last Posted Date: 2016-10-21

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 35

Registration Number: NCT00023231

Locations: 🇺🇸
Lauren Schenker, Rockville, Maryland, United States

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