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HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Cidofovir (Drug); Probenecid (Drug)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Clinical Details

Official title: HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Detailed description: In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

UCSD - Shiley Eye Ctr / SOCA, La Jolla, California 920930946, United States

UCLA - Jules Stein Eye Institute / SOCA, Los Angeles, California 900957003, United States

UCSF - San Francisco Gen Hosp, San Francisco, California 94143, United States

Northwestern Univ / SOCA, Chicago, Illinois 60611, United States

Johns Hopkins Hosp / SOCA, Baltimore, Maryland 212879217, United States

New York Univ Med Ctr / SOCA, New York, New York 10016, United States

Univ of North Carolina / SOCA, Chapel Hill, North Carolina 275997030, United States

Additional Information

Related publications:

Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74.


Last updated: October 31, 2012

Page last updated: August 23, 2015

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