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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Valganciclovir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Cornell AIDS Clinical Trials Unit

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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268B

Identifier Type: -

Identifier Source: org_study_id