HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

• Status: Completed
• Trial end date: 1996-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Gilead Sciences
• Treatments: Cidofovir; Probenecid

Criteria

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.