A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.

Key facts

Study ID

NCT00002257

Run by

Hoffmann-La Roche

People needed

150

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…

• Patients must have the following:
• Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.
• CMV retinitis diagnosed within one month of study entry.
• Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.

You may not qualify if…

• Concurrent Medication:
• The following are excluded:
• Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.
• Patients with the following are excluded:
• Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.
• Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.
• Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).
• Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.
• History of hypersensitivity to acyclovir or ganciclovir.
• Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.
• Prior Medication:
• The following are excluded:
• Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States
• Dr David Busch — San Francisco, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Med Service — Miami, Florida, United States
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med College — New York, New York, United States
• Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Saint Paul's Hosp — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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