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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002222

Purpose

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.

Condition	Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Valganciclovir

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ganciclovir Ganciclovir sodium Valganciclovir hydrochloride Valganciclovir

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

200

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002222

Locations

United States, New York
Cornell AIDS Clinical Trials Unit
New York, New York, United States, 10021

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002222 History of Changes
Other Study ID Numbers:	268B
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Ganciclovir
Antiviral Agents

Drug Administration Schedule
Cytomegalovirus Retinitis
Prodrugs

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Valganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012