A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of...

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ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia.
• • Topical ophthalmics.
• • Topical acyclovir.
• Concurrent Treatment:
• Allowed:
• • Hemodialysis for patients with renal impairment.
• Patients must have:
• • Diagnosis of AIDS and immediately sight-threatening cytomegalovirus retinitis.
• Prior Medication:
• Allowed:
• • Zidovudine.
• • Prior therapy for retinitis.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Non-immediately sight-threatening cytomegalovirus retinitis.
• Concurrent Medication:
• Excluded:
• • Systemic investigational agents such as antimetabolites, alkylating agents, nucleoside analogs, acyclovir sodium (Zovirax).
• • Interferon.
• • Cytokines.
• • Foscarnet (non-nucleoside pyrophosphate analog).
• • Ganciclovir may be withheld for up to 21 days for an acute course with an investigational or toxic therapy or oral / IV acyclovir.
• Patients with the following are excluded:
• • Non-immediately sight-threatening cytomegalovirus retinitis.