A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis.

Key facts

Study ID

NCT00002247

Run by

Hoffmann-La Roche

People needed

225

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:
• Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
• ddI.
• ddC.
• Patients must have:
• Confirmed HIV infection or diagnosis of AIDS.
• CMV retinitis of no more than 4 months duration.
• Stable retinitis.
• Understanding of the nature of the study, agree to its provisions, and sign informed consent.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease.
• Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
• Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment).
• Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol.
• Concurrent Medication:
• Excluded:
• Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
• Antimetabolites.
• Alkylating agents.
• Selected nucleoside analogs.
• Selected cytokines.
• Patients with the following prior conditions are excluded:
• Diagnosis of CMV retinitis more than 4 months prior to study entry.
• More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted).
• Prior Medication:
• Excluded:
• More than two induction treatment regimens with IV ganciclovir.
• Prior oral ganciclovir (in Groups A, B, and C only).

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• AIDS Clinical Research Ctr / UCLA Med Ctr — Los Angeles, California, United States
• UCSD Med Ctr / Pediatrics — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States
• Mount Zion Med Ctr — 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
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Margo Heath - Chiozzi — Honolulu, Hawaii, United States
• Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll — Chicago, Illinois, United States
• Beth Israel Hosp — Boston, Massachusetts, United States
• Dr Dorothy Friedberg — 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
• Oak Lawn Physicians Group — Dallas, Texas, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Univ of Washington / Pacific Med Ctr — Seattle, Washington, United States
• Saint Paul's Hosp — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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