An Open Label Study of the Safety and Tolerability of Valganciclovir, an Oral Prodrug of Ganciclovir, for the Treatment of Cytomegalovirus Retinitis in Subjects With AIDS

Inclusion Criteria Concurrent Medication: Allowed with caution: Acyclovir. Famciclovir. Valaciclovir. Imipenem-cilastatin. Myelosuppressive agents. Patients must have: HIV infection with CMV retinitis. Minimum of 4 weeks prior treatment with ganciclovir, foscarnet, or cidofovir. Intraocular implant in either or both eyes, as long as CMV retinitis is active in one eye, upon approval by Roche. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms of conditions are excluded: Active extraocular CMV disease. Severe uncontrolled diarrhea or evidence of malabsorption. Concurrent Medication: Excluded: Foscarnet. Cidofovir. CMV hyperimmune globulin. Probenecid. Patients with the following prior conditions are excluded: Ocular media opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment. Simultaneous participation in another study (unless approved by Roche). Required: A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir. Approval required for prior use of investigational anti-CMV agents.