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

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002257
  Purpose

To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

ChemIDplus related topics:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Placebo Control, Safety Study
Official Title:   A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

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

Estimated Enrollment:   150

Detailed Description:

Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.

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

Criteria

Inclusion Criteria

Patients must have the following:

  • Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.
  • CMV retinitis diagnosed within one month of study entry.
  • Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.

Exclusion Criteria

Concurrent Medication:

The following are excluded:

  • Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.

Patients with the following are excluded:

  • Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.
  • Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.
  • Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).
  • Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.
  • History of hypersensitivity to acyclovir or ganciclovir.
  • Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.

Prior Medication:

The following are excluded:

- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002257

Locations
United States, California
Davies Med Ctr / c/o HIV Institute    
      San Francisco, California, United States, 94114
East Bay AIDS Ctr    
      Berkeley, California, United States, 94704
Dr David Busch    
      San Francisco, California, United States, 94118
United States, District of Columbia
Georgetown Univ Med Ctr    
      Washington, District of Columbia, United States, 20007
United States, Florida
Miami Veterans Administration Med Ctr    
      Miami, Florida, United States, 33125
Med Service    
      Miami, Florida, United States, 33125
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr    
      Chicago, Illinois, United States, 60612
United States, Massachusetts
Beth Israel Deaconess Med Ctr    
      Boston, Massachusetts, United States, 02215
United States, New York
New York Univ Med Ctr    
      New York, New York, United States, 10016
Cornell Univ Med College    
      New York, New York, United States, 10021
United States, Pennsylvania
Buckley Braffman Stern Med Associates    
      Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Univ TX Galveston Med Branch    
      Galveston, Texas, United States, 77550
Canada, British Columbia
Saint Paul's Hosp    
      Vancouver, British Columbia, Canada

Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Study ID Numbers:   059B, ICM 1653
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002257
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Ganciclovir  
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Eye Infections, Viral
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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