A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002034
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1992
  Purpose

To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Zidovudine
Drug: Ganciclovir

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 100
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical acyclovir.
  • Selected cytokines.
  • Allowed after the first 4 weeks of ganciclovir:
  • Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.
  • Other anti-retrovirals after consultation with the Syntex study monitor.

Patients must have the following:

  • AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
  • An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).
  • Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
  • Ocular conditions requiring immediate surgical correction (eg:
  • retinal tear or detachment).
  • Demonstrated hypersensitivity to acyclovir or ganciclovir.
  • Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol.

Concurrent Medication:

Excluded:

  • Antimetabolites.
  • Alkylating agents.
  • Nucleoside analogs (excluding selected anti-retroviral agents).
  • Imipenem-cilastatin.
  • Interferons.
  • Selected cytokines.
  • Acyclovir (except topical acyclovir).

Patients with the following are excluded:

  • Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).
  • Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.

Prior Medication:

Excluded within 1 month of study entry:

  • Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002034

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Georgia
Dr Winkler Weinberg
Roswell, Georgia, United States, 30076
United States, New York
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States, 117948153
United States, South Carolina
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States, 29204
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Canada, Alberta
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta, Canada
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002034     History of Changes
Other Study ID Numbers: 029F, ICM 1692
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
AIDS-Related Opportunistic Infections
Ganciclovir
Drug Interactions
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:
Infection
Communicable Diseases
Retinitis
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinal Diseases
Eye Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Zidovudine
Ganciclovir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014