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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002222
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
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
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.
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.
Interventional
Not Provided
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Valganciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002222
268B
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP