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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002247
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1993
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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: NCT00002247

Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94704
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, United States, 900951793
UCSD Med Ctr / Pediatrics
San Diego, California, United States, 92103
Davies Med Ctr / c/o HIV Institute
San Francisco, California, United States, 94114
Mount Zion Med Ctr
San Francisco, California, United States, 94115
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
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
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
Oak Lawn Physicians Group
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
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:
ClinicalTrials.gov Identifier: NCT00002247     History of Changes
Other Study ID Numbers: 059C, ICM 1774
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
Ganciclovir
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Retinitis
Cytomegalovirus Retinitis
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
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014