HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Inclusion Criteria

Concurrent Medication:

Allowed:

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

Patients must have:

• AIDS by CDC criteria.
• CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.

Prior Medication:

Allowed:

• Prophylaxis with anti-CMV agents.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
• Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Patients with the following prior conditions are excluded:

• History of renal disease or renal dialysis.
• History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
• History of clinically significant probenecid allergy.

Prior Medication:

Excluded:

• Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
• Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Drug or alcohol abuse sufficient to hinder compliance with study.