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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

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002247
  Purpose

To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe 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, Randomized, Safety Study
Official Title:   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

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

Estimated Enrollment:   225

Detailed Description:

Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
  • ddI.
  • ddC.

Patients must have:

  • Confirmed HIV infection or diagnosis of AIDS.
  • CMV retinitis of no more than 4 months duration.
  • Stable retinitis.
  • Understanding of the nature of the study, agree to its provisions, and sign informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease.
  • Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
  • Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment).
  • Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol.

Concurrent Medication:

Excluded:

  • Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
  • Antimetabolites.
  • Alkylating agents.
  • Selected nucleoside analogs.
  • Selected cytokines.

Patients with the following prior conditions are excluded:

  • Diagnosis of CMV retinitis more than 4 months prior to study entry.
  • More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted).

Prior Medication:

Excluded:

  • More than two induction treatment regimens with IV ganciclovir.
  • Prior oral ganciclovir (in Groups A, B, and C only).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002247

Locations
United States, California
San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
Davies Med Ctr / c/o HIV Institute    
      San Francisco, California, United States, 94114
UCSD Med Ctr / Pediatrics    
      San Diego, California, United States, 92103
East Bay AIDS Ctr    
      Berkeley, California, United States, 94704
Mount Zion Med Ctr    
      San Francisco, California, United States, 94115
Dr David Busch    
      San Francisco, California, United States, 94118
AIDS Clinical Research Ctr / UCLA Med Ctr    
      Los Angeles, California, United States, 900951793
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
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308
United States, Hawaii
Margo Heath - Chiozzi    
      Honolulu, Hawaii, United States, 96816
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll    
      Chicago, Illinois, United States, 60612
United States, Massachusetts
Beth Israel Hosp    
      Boston, Massachusetts, United States, 02215
United States, New York
Dr Dorothy Friedberg    
      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
Oak Lawn Physicians Group    
      Dallas, Texas, United States, 75219
United States, Washington
Univ of Washington / Pacific Med Ctr    
      Seattle, Washington, United States, 98144
Canada, British Columbia
Saint Paul's Hosp    
      Vancouver, British Columbia, Canada

Sponsors and Collaborators
Hoffmann-La Roche
  More Information


Publications:

Study ID Numbers:   059C, ICM 1774
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002247
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Ganciclovir  
Cytomegalovirus Infections  
Administration, Oral  
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 October 07, 2008




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