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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Valganciclovir

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Ganciclovir, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, Prodrugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cornell AIDS Clinical Trials Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002222

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00002222

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 1999

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Retinitis, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Ganciclovir, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, Prodrugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Valganciclovir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Cornell AIDS Clinical Trials Unit

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Cytomegalovirus Retinitis, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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