A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002222

Run by

Hoffmann-La Roche

People needed

200

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cornell AIDS Clinical Trials Unit — New York, New York, United States

Full record on ClinicalTrials.gov

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