Search / Trial NCT00001028

A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Pneumonia, Pneumocystis Carinii Pentamidine Dapsone Acquired Immunodeficiency Syndrome Aids Related Complex

Description

Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole. Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly. Follow-up data is collected every 3 months, and patients are clinically evaluated every 6 months. Patients who develop PCP or a severe or persistent study drug toxicity may be switched ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV infection.
  • CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocytes OR a history of prior PCP.
  • History of intolerance to trimethoprim and/or sulfonamides.
  • No active pneumocystosis. Patient or guardian must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.
  • Exclusion Criteria
  • Concurrent Medication:
  • Excluded:
  • Any medication with potential anti-PCP activity.
  • Patients with the following prior conditions are excluded:
  • Treatment-limiting reaction to pentamidine or dapsone.

Attachments

readout_NCT00001028_2024-03-05.pdf

4.5 MB

NCT00001028_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

Denver, Colorado, United States

Wilmington, Delaware, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Bronx, New York, United States

New York, New York, United States

Richmond, Virginia, United States

San Francisco, California, United States

Portland, Oregon, 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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1 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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