The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis
in patients who have been treated for this condition in the past. This study also examines
the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.
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.
Allowed with caution:
- 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.
Patients with any of the following symptoms of conditions are excluded:
- Active extraocular CMV disease.
- Severe uncontrolled diarrhea or evidence of malabsorption.
- CMV hyperimmune globulin.
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).
- A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir.
- Approval required for prior use of investigational anti-CMV agents.