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
Completed · Not applicable
Conditions studied: Cytomegalovirus Retinitis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002134
- Run by
- Roche Global Development
- People needed
- 450
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
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.
- Valacyclovir.
- Foscarnet.
- CMV hyperimmune globulin.
- Soluble CD4.
- Trichosanthin.
- Imipenem-cilastatin.
- Isoprinosine.
- Levamisole.
- Interferon.
- Other investigational drugs.
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.