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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002222

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1999
History of Changes
Purpose

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: Masking: None (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

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002222   History of Changes  
Other Study ID Numbers: 268B  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

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
Retinitis
Cytomegalovirus Retinitis
Ganciclovir
Valganciclovir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.