Patients receive valganciclovir twice a day for 21 days as induction therapy then daily as maintenance therapy. Patients are encouraged to remain on study for at least 3 months and will remain until common study closure.

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.