Search / Trial NCT00000863

A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients

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

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Administration, Oral Wr 6026

Description

All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Any medications not listed as excluded will be permitted on study.
  • [ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.]
  • Patients must have:
  • Documented HIV infection.
  • Documented PCP.
  • On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg.
  • Signed informed consent from parent or legal guardian for those patients less than 18 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known hypersensitivity to quinolines.
  • If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study.
  • Concurrent Medication:
  • Excluded:
  • Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine).
  • Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites).
  • Patients with the following prior conditions or symptoms are excluded:
  • History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency.
  • Prior Medication:
  • Excluded:
  • More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry.

Attachments

readout_NCT00000863_2024-07-23.pdf

4.5 MB

NCT00000863_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

Birmingham, Alabama, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Buffalo, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Chicago, Illinois, United States

Honolulu, Hawaii, United States

Indianapolis, Indiana, 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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4 stars
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3 stars
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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?

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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