Search / Trial NCT00002437

The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Launched by GILEAD SCIENCES · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Retinitis Probenecid Drug Therapy, Combination Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents Cidofovir

ClinConnect Summary

Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral agents.
  • Oral trimethoprim/sulfamethoxazole.
  • Aerosolized pentamidine.
  • Dapsone.
  • Fluconazole.
  • Rifabutin.
  • Filgrastim (G-CSF).
  • p24 vaccine.
  • Patients must have:
  • Diagnosis of AIDS by CDC criteria.
  • Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.
  • Visual acuity in the affected eye of \>= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance.
  • Life expectancy of at least 3 months.
  • Consent of parent or guardian in patients less than 18 years of age.
  • Prior Medication:
  • Allowed:
  • Acyclovir.
  • Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Media opacity that precludes visualization of the fundus of both eyes.
  • Retinal detachment.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Active medical problems considered sufficient to hinder study compliance.
  • Known clinically significant allergy to probenecid.
  • Concurrent Medication:
  • Excluded:
  • Acyclovir (may be reinstituted following development of herpetic lesions).
  • Ganciclovir.
  • Foscarnet.
  • Amphotericin B.
  • Diuretics.
  • Aminoglycoside antibiotics.
  • CMV hyperimmune immunoglobulin.
  • Intravenous pentamidine.
  • Other nephrotoxic agents.
  • Other investigational drugs with potential nephrotoxicity.
  • Prior Medication:
  • Excluded:
  • Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).
  • Excluded within 1 week prior to study entry:
  • Amphotericin B.
  • Vidarabine.
  • Other nephrotoxic agents.
  • Aminoglycoside antibiotics.
  • Intravenous pentamidine. Drug or alcohol abuse.

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.

Locations

Los Angeles, California, United States

San Francisco, California, United States

San Antonio, Texas, United States

Rochester, New York, United States

Boston, Massachusetts, United States

Orange, California, United States

Chapel Hill, North Carolina, United States

Princeton, New Jersey, United States

London Sw 10, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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