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
Roche Global Development
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1997
History of Changes
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.
Drug : Ganciclovir
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Topical drugs and ophthalmics.
- Unilateral CMV retinitis.
- 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.
- Amantadine hydrochloride.
- FIAC or FIAU.
- CMV hyperimmune globulin.
- Soluble CD4.
- Other investigational drugs.
- 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.
- 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
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002134
Locations Show More
|United States, California|
|Dr Neil Brourman|
|Beverly Hills, California, United States, 90211|
|UCI College of Medicine|
|Irvine, California, United States, 92715|
|Estelle Doheny Eye Clinic|
|Los Angeles, California, United States, 90033|
|Dr Robert T Wendel|
|Sacramento, California, United States, 95819|
|San Francisco, California, United States, 94115|
|Pacific Horizons Med Group|
|San Francisco, California, United States, 94115|
|Santa Clara Valley Med Ctr|
|San Jose, California, United States, 95128|
|Dr Robert Avery|
|Santa Barbara, California, United States, 93103|
|Harbor - UCLA Med Ctr|
|Torrance, California, United States, 90509|
|United States, District of Columbia|
|Dr Alan Palestine|
|Washington, District of Columbia, United States, 20036|
|United States, Florida|
|Dr Michael Stewart|
|Jacksonville, Florida, United States, 32204|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Emory Eye Clinic|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Dr David Weinberg|
|Chicago, Illinois, United States, 60611|
|United States, Kentucky|
|Univ of Kentucky Med Ctr|
|Lexington, Kentucky, United States, 40536|
|United States, Massachusetts|
|New England Med Ctr / Tufts Univ|
|Boston, Massachusetts, United States, 02111|
|United States, New York|
|Dr Dorothy Friedberg|
|New York, New York, United States, 10016|
|Saint Clare's Prof Office|
|New York, New York, United States, 10019|
|New York Hosp|
|New York, New York, United States, 10021|
|Vitreo - Retinal Consultants|
|New York, New York, United States, 10028|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr of Dallas|
|Dallas, Texas, United States, 75235|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Univ of Washington Med Ctr|
|Seattle, Washington, United States, 98195|
Sponsors and CollaboratorsRoche Global Development
|Responsible Party:||Roche Global Development|
|ClinicalTrials.gov Identifier:||NCT00002134 History of Changes|
|Other Study ID Numbers:||037B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Retinitis
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.