A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Launched by ROCHE GLOBAL DEVELOPMENT · Aug 30, 2001

Keywords

ClinConnect Summary

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.
• • Cytarabine.
• • Idoxuridine.
• • Ribavirin.
• • Interferon.
• • Foscarnet (non-nucleoside pyrophosphate analogue).
• • CMV hyperimmune globulin.
• • Soluble CD4.
• • Trichosanthin (Compound Q).
• • Imipenem-cilastatin.
• • Isoprinosine.
• • Levamisole.
• • Other investigational drugs.
• Patients with the following prior condition are excluded:
• • History of hypersensitivity to acyclovir or ganciclovir.
• Prior Medication:
• Excluded:
• • More than three induction regimens with intravenous anti-CMV therapy.
• • Any prior oral ganciclovir.