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

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.