A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
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
2 other identifiers
interventional
280
2 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Topical and ophthalmic nucleoside analogues.
- Patients must have:
- 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.
- Prior Medication:
- Allowed:
- Foscarnet prior to the 4 weeks of intravenous induction therapy.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- 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.
- Concurrent Medication:
- Excluded:
- Acyclovir sodium (Zovirax) by any route other than topical.
- Valacyclovir.
- Brovavir.
- Vidarabine.
- Amantadine hydrochloride.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294, United States
McDowell Clinic
Phoenix, Arizona, 85006, United States
Dr Ken Fisher
Phoenix, Arizona, 85013, United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793, United States
UCSD Med Ctr / Pediatrics
San Diego, California, 92103, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Community Research Initiative
Coral Gables, Florida, 33146, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Margo Heath - Chiozzi
Honolulu, Hawaii, 96816, United States
Univ of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
AIDS Clinical Trials Unit
St Louis, Missouri, 63108, United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102, United States
Univ of New Mexico
Albuquerque, New Mexico, 87131, United States
AIDS Wellness Clinic
Sante Fe, New Mexico, 87501, United States
Dr Dorothy Friedberg
New York, New York, 10016, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
New York Hosp - Cornell Med Ctr
New York, New York, 10021, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215, United States
Nalle Clinic
Charlotte, North Carolina, 282072198, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Hosp
Columbus, Ohio, 432101228, United States
Associates Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905, United States
Dr Daniel Barbero
Fort Worth, Texas, 76104, United States
Infectious Diseases Association of Houston
Houston, Texas, 77030, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Related Publications (1)
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)
BACKGROUND