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

Associated Therapies: -

Clinical Trials

A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

Phase 1

Completed

Conditions: Cytomegalovirus Retinitis
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: 48

Registration Number: NCT00000668

Locations: 🇺🇸
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, United States
🇺🇸
Univ of California / San Diego Treatment Ctr, San Diego, California, United States
🇺🇸
Cornell Univ Med Ctr, New York, New York, United States

and more 2 locations

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

Phase 1

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: 25

Registration Number: NCT00001062

Locations: 🇺🇸
Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States
🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States
🇺🇸
Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States

and more 3 locations

Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

Phase 2

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-11-01

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

Target Recruit Count: 167

Registration Number: NCT00001061

Locations: 🇺🇸
USC CRS, Los Angeles, California, United States
🇺🇸
Cook County Hosp. CORE Ctr., Chicago, Illinois, United States
🇺🇸
Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States

and more 17 locations

A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Phase 1

Completed

Conditions: Cytomegalovirus Retinitis
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2021-10-27

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

Target Recruit Count: 38

Registration Number: NCT00000673

Locations: 🇺🇸
Univ. of Miami AIDS CRS, Miami, Florida, United States
🇺🇸
Washington U CRS, Saint Louis, Missouri, United States

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Phase 2

Completed

Conditions: Gastrointestinal Diseases
Cytomegalovirus Retinitis
HIV Infections

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: 850

Registration Number: NCT00001034

Locations: 🇺🇸
Community Consortium of San Francisco, San Francisco, California, United States
🇺🇸
Denver CPCRA / Denver Public Hlth, Denver, Colorado, United States
🇺🇸
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, United States

and more 14 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

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

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

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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