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
2 other identifiers
interventional
225
2 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
East Bay AIDS Ctr
Berkeley, California, 94704, United States
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793, United States
UCSD Med Ctr / Pediatrics
San Diego, California, 92103, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Dr David Busch
San Francisco, California, 94118, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Margo Heath - Chiozzi
Honolulu, Hawaii, 96816, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612, United States
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Dr Dorothy Friedberg
New York, New York, 10016, United States
Cornell Univ Med College
New York, New York, 10021, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Oak Lawn Physicians Group
Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144, United States
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Related Publications (1)
Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.
PMID: 9110064BACKGROUND