HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000799

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Expected to finish

1996-04-01

Last updated by the study team

2012-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD - Shiley Eye Ctr / SOCA — La Jolla, California, United States
• UCLA - Jules Stein Eye Institute / SOCA — Los Angeles, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Northwestern Univ / SOCA — Chicago, Illinois, United States
• Johns Hopkins Hosp / SOCA — Baltimore, Maryland, United States
• New York Univ Med Ctr / SOCA — New York, New York, United States
• Univ of North Carolina / SOCA — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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