MedPath

Ganciclovir

Generic Name
Ganciclovir
Brand Names
Cytovene, Zirgan
Drug Type
Small Molecule
Chemical Formula
C9H13N5O4
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

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

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

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

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons 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
100
Registration Number
NCT00002034
Locations
🇺🇸

Dr Alfred F Burnside Jr, Columbia, South Carolina, United States

🇺🇸

SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York, United States

🇨🇦

Southern Alberta HIV Clinic / Foothills Hosp, Calgary, Alberta, Canada

and more 6 locations

A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

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
225
Registration Number
NCT00002247
Locations
🇺🇸

Mount Zion Med Ctr, San Francisco, California, United States

🇺🇸

Dr Dorothy Friedberg, New York, New York, United States

🇺🇸

Georgetown Univ Med Ctr, Washington, District of Columbia, United States

and more 17 locations

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Phase 3
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
180
Registration Number
NCT00000688
Locations
🇺🇸

Univ of California / San Diego Treatment Ctr, San Diego, California, United States

🇺🇸

Stanford Univ School of Medicine, Stanford, California, United States

🇺🇸

Kansas City Veterans Administration Med Ctr, Kansas City, Missouri, United States

and more 19 locations

CMV Retinitis Retreatment Trial

Phase 2
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2011-03-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
300
Registration Number
NCT00000766
Locations
🇺🇸

Johns Hopkins Hosp / SOCA, Baltimore, Maryland, United States

🇺🇸

New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA, New York, New York, United States

🇺🇸

Mount Sinai Med Ctr / SOCA, New York, New York, United States

and more 6 locations

Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

Phase 4
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2011-02-23
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
300
Registration Number
NCT00000894
Locations
🇺🇸

Cornell Univ Med Ctr, New York, New York, United States

🇺🇸

Julio Arroyo, West Columbia, South Carolina, United States

🇺🇸

New York Hosp / Cornell Med Ctr, New York, New York, United States

and more 9 locations

A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Phase 3
Completed
Conditions
Cytomegalovirus Infections
First Posted Date
2001-08-31
Last Posted Date
2010-08-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
130
Registration Number
NCT00001100
Locations
🇺🇸

NIAID/DMID/CASG Central Unit, Birmingham, Alabama, United States

A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

Phase 3
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2008-09-30
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00000698
Locations
🇺🇸

Natl Inst of Allergy & Infect Dis / Cln Ctr, Bethesda, Maryland, United States

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