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 May 19, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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