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
NCT ID: NCT00002134
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
450 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Topical drugs and ophthalmics.
Patients must have:
* AIDS.
* Unilateral CMV retinitis.
Exclusion Criteria
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.
* Valacyclovir.
* Foscarnet.
* CMV hyperimmune globulin.
* Soluble CD4.
* Trichosanthin.
* Imipenem-cilastatin.
* Isoprinosine.
* Levamisole.
* Interferon.
* Other investigational drugs.
Patients with the following prior conditions are excluded:
* History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
* History of hypersensitivity to acyclovir or ganciclovir.
Prior Medication:
Excluded:
* Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
* Prior intravitreal ganciclovir implant.
* More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
* Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
13 Years
ALL
No
Sponsors
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Roche Global Development
OTHER
Locations
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Dr Neil Brourman
Beverly Hills, California, United States
UCI College of Medicine
Irvine, California, United States
Estelle Doheny Eye Clinic
Los Angeles, California, United States
Dr Robert T Wendel
Sacramento, California, United States
Kaiser Hosp
San Francisco, California, United States
Pacific Horizons Med Group
San Francisco, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
Dr Robert Avery
Santa Barbara, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Dr Alan Palestine
Washington D.C., District of Columbia, United States
Dr Michael Stewart
Jacksonville, Florida, United States
Bascom Palmer
Miami, Florida, United States
Emory Eye Clinic
Atlanta, Georgia, United States
Dr David Weinberg
Chicago, Illinois, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, United States
New England Med Ctr / Tufts Univ
Boston, Massachusetts, United States
Dr Dorothy Friedberg
New York, New York, United States
Saint Clare's Prof Office
New York, New York, United States
New York Hosp
New York, New York, United States
Vitreo - Retinal Consultants
New York, New York, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Univ of Washington Med Ctr
Seattle, Washington, United States
Countries
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References
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Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.
Other Identifiers
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GANS2304
Identifier Type: -
Identifier Source: secondary_id
037B
Identifier Type: -
Identifier Source: org_study_id