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

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.