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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Ganciclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roche Global Development
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.
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Detailed description:
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant
alone, or IV ganciclovir.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Topical drugs and ophthalmics.
Patients must have:
- AIDS.
- Unilateral CMV retinitis.
Exclusion Criteria
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.
- 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).
Locations and Contacts
Pacific Horizons Med Group, San Francisco, California 94115, United States
Dr Robert Avery, Santa Barbara, California 93103, United States
Dr Neil Brourman, Beverly Hills, California 90211, United States
Estelle Doheny Eye Clinic, Los Angeles, California 90033, United States
Harbor - UCLA Med Ctr, Torrance, California 90509, United States
Santa Clara Valley Med Ctr, San Jose, California 95128, United States
Dr Robert T Wendel, Sacramento, California 95819, United States
Kaiser Hosp, San Francisco, California 94115, United States
UCI College of Medicine, Irvine, California 92715, United States
Dr Alan Palestine, Washington, District of Columbia 20036, United States
Bascom Palmer, Miami, Florida 33136, United States
Dr Michael Stewart, Jacksonville, Florida 32204, 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
New York Hosp, New York, New York 10021, United States
Saint Clare's Prof Office, New York, New York 10019, 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
Additional Information
Related publications: Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4. No abstract available.
Last updated: June 23, 2005
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