Search / Trial NCT00002222

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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Aids Related Opportunistic Infections Ganciclovir Antiviral Agents Drug Administration Schedule Cytomegalovirus Retinitis Prodrugs

ClinConnect Summary

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.

Gender

ALL

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.

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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