Search / Trial NCT00000799

HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Retinitis Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents Cidofovir

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...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000799_2024-03-02.pdf

4.5 MB

NCT00000799_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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