A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
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: April 1996
History of Changes
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Drug : Ganciclovir
Primary Purpose: Treatment
|Official Title:||A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Topical and ophthalmic nucleoside analogues.
- HIV positive.
- No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
- Currently stable retinitis.
- Foscarnet prior to the 4 weeks of intravenous induction therapy.
- Persistent or clinically significant diarrhea, nausea, or abdominal pain.
- Severe odynophagia.
- Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
- Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
- Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
- Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
- Acyclovir sodium (Zovirax) by any route other than topical.
- Amantadine hydrochloride.
- Foscarnet (non-nucleoside pyrophosphate analogue).
- CMV hyperimmune globulin.
- Soluble CD4.
- Trichosanthin (Compound Q).
- Other investigational drugs.
- More than three induction regimens with intravenous anti-CMV therapy.
- Any prior oral ganciclovir.
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
History of hypersensitivity to acyclovir or ganciclovir.
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: NCT00002330
Locations Show More
|United States, Alabama|
|Univ of Alabama at Birmingham / AIDS Outpatient Clinic|
|Birmingham, Alabama, United States, 35294|
|United States, Arizona|
|Phoenix, Arizona, United States, 85006|
|Dr Ken Fisher|
|Phoenix, Arizona, United States, 85013|
|Univ of Arizona / Health Science Ctr|
|Tucson, Arizona, United States, 85724|
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|AIDS Clinical Research Ctr / UCLA Med Ctr|
|Los Angeles, California, United States, 900951793|
|UCSD Med Ctr / Pediatrics|
|San Diego, California, United States, 92103|
|Davies Med Ctr|
|San Francisco, California, United States, 94114|
|Mount Zion Med Ctr / UCSF|
|San Francisco, California, United States, 94115|
|San Francisco Veterans Administration Med Ctr|
|San Francisco, California, United States, 94121|
|United States, District of Columbia|
|George Washington Univ Med Ctr|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Community Research Initiative|
|Coral Gables, Florida, United States, 33146|
|United States, Georgia|
|AIDS Research Consortium of Atlanta|
|Atlanta, Georgia, United States, 30308|
|United States, Hawaii|
|Margo Heath - Chiozzi|
|Honolulu, Hawaii, United States, 96816|
|United States, Maryland|
|Univ of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|United States, Missouri|
|AIDS Clinical Trials Unit|
|St. Louis, Missouri, United States, 63108|
|United States, Nevada|
|HIV Wellness Ctr / Univ Med Ctr|
|Las Vegas, Nevada, United States, 89102|
|United States, New Mexico|
|Univ of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|AIDS Wellness Clinic|
|Sante Fe, New Mexico, United States, 87501|
|United States, New York|
|Dr Dorothy Friedberg|
|New York, New York, United States, 10016|
|Saint Luke's - Roosevelt Hosp Ctr|
|New York, New York, United States, 10019|
|New York Hosp - Cornell Med Ctr|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Univ of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 275997215|
|Charlotte, North Carolina, United States, 282072198|
|United States, Ohio|
|Case Western Reserve Univ|
|Cleveland, Ohio, United States, 44106|
|Ohio State Univ Hosp|
|Columbus, Ohio, United States, 432101228|
|United States, Oklahoma|
|Associates Med and Mental Health|
|Tulsa, Oklahoma, United States, 74114|
|United States, Oregon|
|Portland Veterans Adm Med Ctr / Rsch & Education Grp|
|Portland, Oregon, United States, 97210|
|United States, Pennsylvania|
|Buckley Braffman Stern Med Associates|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Austin Infectious Disease Consultants|
|Austin, Texas, United States, 78705|
|N Texas Ctr for AIDS & Clin Rsch|
|Dallas, Texas, United States, 75219|
|Texas Tech Health Sciences Ctr|
|El Paso, Texas, United States, 79905|
|Dr Daniel Barbero|
|Fort Worth, Texas, United States, 76104|
|Infectious Diseases Association of Houston|
|Houston, Texas, United States, 77030|
|Audie L Murphy Veterans Administration Hosp|
|San Antonio, Texas, United States, 78284|
|Saint Paul's Hosp|
|Vancouver, British Columbia, Canada|
Sponsors and CollaboratorsRoche Global Development
|Responsible Party:||Roche Global Development|
|ClinicalTrials.gov Identifier:||NCT00002330 History of Changes|
|Other Study ID Numbers:||059F|
|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.