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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002222
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002222 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Valganciclovir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002222
268B
Not Provided
Not Provided
Hoffmann-La Roche
Not Provided
Not Provided
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