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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002222
Other study ID # 268B
Secondary ID
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
Est. completion date
Est. primary completion date
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


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, 

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