An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiretroviral agents.
• Oral trimethoprim/sulfamethoxazole.
• Aerosolized pentamidine.
• Dapsone.
• Fluconazole.
• Rifabutin.
• Filgrastim (G-CSF).
• Itraconazole.
• HIV vaccines.

Patients must have:

• AIDS.
• CMV retinitis, with severity as specified in the Disease Status field.
• Life expectancy of at least 3 months.
• Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Known clinically significant allergy to probenecid.
• Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
• Other active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

• Amphotericin B.
• Aminoglycoside antibiotics.
• Vidarabine.
• Intravenous pentamidine.
• CMV hyperimmune immunoglobulin.
• Other nephrotoxic or potentially nephrotoxic agents.
• Other investigational agents with anti-CMV activity.
• Ganciclovir.
• Intravenous or oral acyclovir (except following development of herpetic lesion).
• Foscarnet.
• Diuretics.

Prior Medication:

Excluded within 2 days prior to study entry:

• Ganciclovir or foscarnet.

Excluded within one week prior to study entry:

• Amphotericin B.
• Aminoglycoside antibiotics.
• Vidarabine.
• Intravenous pentamidine.
• CMV hyperimmune immunoglobulin.
• Other nephrotoxic agents.
• Other investigational agents with anti-CMV activity.

Excluded at any time:

Prior systemic or intravitreal HPMPC.

Drug or alcohol abuse that is considered sufficient to hinder study compliance.