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

Completed · Phase 3

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. 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 CMV retinitis.

Key facts

Study ID

NCT00000698

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

Expected to finish

2007-08-01

Last updated by the study team

2008-09-30

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Natl Inst of Allergy & Infect Dis / Cln Ctr — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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