Search / Trial NCT00002330

A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Launched by ROCHE GLOBAL DEVELOPMENT · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Retinitis Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

ClinConnect Summary

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Topical and ophthalmic nucleoside analogues.
  • Patients must have:
  • HIV positive.
  • No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
  • Currently stable retinitis.
  • Prior Medication:
  • Allowed:
  • Foscarnet prior to the 4 weeks of intravenous induction therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Persistent or clinically significant diarrhea, nausea, or abdominal pain.
  • Severe odynophagia.
  • Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
  • Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
  • Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
  • Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
  • Concurrent Medication:
  • Excluded:
  • Acyclovir sodium (Zovirax) by any route other than topical.
  • Valacyclovir.
  • Brovavir.
  • Vidarabine.
  • Amantadine hydrochloride.
  • Cytarabine.
  • Idoxuridine.
  • Ribavirin.
  • Interferon.
  • Foscarnet (non-nucleoside pyrophosphate analogue).
  • CMV hyperimmune globulin.
  • Soluble CD4.
  • Trichosanthin (Compound Q).
  • Imipenem-cilastatin.
  • Isoprinosine.
  • Levamisole.
  • Other investigational drugs.
  • Patients with the following prior condition are excluded:
  • History of hypersensitivity to acyclovir or ganciclovir.
  • Prior Medication:
  • Excluded:
  • More than three induction regimens with intravenous anti-CMV therapy.
  • Any prior oral ganciclovir.

About Roche Global Development

Roche Global Development is a leading biopharmaceutical company dedicated to advancing innovative therapies that address significant unmet medical needs. As a division of Roche, a pioneer in personalized medicine, Global Development focuses on the clinical development of novel drugs and diagnostics across a wide range of therapeutic areas, including oncology, immunology, and infectious diseases. With a commitment to excellence in clinical research and patient safety, Roche Global Development leverages cutting-edge technologies and robust scientific expertise to accelerate the delivery of groundbreaking treatments to patients worldwide. Through collaboration with healthcare professionals and regulatory authorities, Roche strives to enhance patient outcomes and improve global health.

Locations

New York, New York, United States

San Francisco, California, United States

Atlanta, Georgia, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

San Antonio, Texas, United States

Dallas, Texas, United States

Portland, Oregon, United States

San Francisco, California, United States

Vancouver, British Columbia, Canada

Albuquerque, New Mexico, United States

Tucson, Arizona, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

New York, New York, United States

New York, New York, United States

El Paso, Texas, United States

Charlotte, North Carolina, United States

Fort Worth, Texas, United States

Berkeley, California, United States

Coral Gables, Florida, United States

Houston, Texas, United States

Phoenix, Arizona, United States

Austin, Texas, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

San Diego, California, United States

Honolulu, Hawaii, United States

Tulsa, Oklahoma, United States

Phoenix, Arizona, United States

Baltimore, Maryland, United States

St. Louis, Missouri, United States

Las Vegas, Nevada, United States

Sante Fe, New Mexico, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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