A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
2 other identifiers
interventional
450
1 country
23
Brief Summary
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
23 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
July 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Topical drugs and ophthalmics.
- Patients must have:
- AIDS.
- Unilateral CMV retinitis.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
- Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
- Acute retinal necrosis or any other intraocular condition that might preclude study completion.
- Ocular condition requiring immediate surgery.
- Unable to have long-term IV catheter placement.
- Concurrent Medication:
- Excluded:
- Vidarabine.
- Amantadine hydrochloride.
- Cytarabine.
- FIAC or FIAU.
- Idoxuridine.
- Ribavirin.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Dr Neil Brourman
Beverly Hills, California, 90211, United States
UCI College of Medicine
Irvine, California, 92715, United States
Estelle Doheny Eye Clinic
Los Angeles, California, 90033, United States
Dr Robert T Wendel
Sacramento, California, 95819, United States
Kaiser Hosp
San Francisco, California, 94115, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Santa Clara Valley Med Ctr
San Jose, California, 95128, United States
Dr Robert Avery
Santa Barbara, California, 93103, United States
Harbor - UCLA Med Ctr
Torrance, California, 90509, United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20036, United States
Dr Michael Stewart
Jacksonville, Florida, 32204, United States
Bascom Palmer
Miami, Florida, 33136, United States
Emory Eye Clinic
Atlanta, Georgia, 30322, United States
Dr David Weinberg
Chicago, Illinois, 60611, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
New England Med Ctr / Tufts Univ
Boston, Massachusetts, 02111, United States
Dr Dorothy Friedberg
New York, New York, 10016, United States
Saint Clare's Prof Office
New York, New York, 10019, United States
New York Hosp
New York, New York, 10021, United States
Vitreo - Retinal Consultants
New York, New York, 10028, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Univ of Washington Med Ctr
Seattle, Washington, 98195, United States
Related Publications (1)
Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.
PMID: 11363508BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-07