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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002222
• Other study ID #: 268B
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Valganciclovir

Locations

Country	Name	City	State
United States	Cornell AIDS Clinical Trials Unit	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States,