Completed

NCT Number: NCT00002222

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

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.

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Key information

Conditions

Cytomegalovirus Retinitis AIDS-Related Opportunistic Infections Amino Acid Metabolism, Inborn Errors Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases Opportunistic Infections RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornell AIDS Clinical Trials Unit

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valganciclovir

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed