Search / Trial NCT00000739

Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Pneumonia, Pneumocystis Carinii Dapsone Acquired Immunodeficiency Syndrome Aids Related Complex Drug Administration Schedule

Description

Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established. Ninety-six HIV-infected infants and children who are intolerant to trimethoprim / sulfamethoxazole ( TMP / SMX ) are randomized to rece...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Rifampin and rifampin derivatives for up to 1 week during the study.
  • Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician).
  • Patients must have:
  • Evidence of HIV infection.
  • PER AMENDMENT 11/16/95:
  • Children who require prophylaxis. (Was written - Risk of developing PCP.)
  • Known intolerance to TMP / SMX.
  • Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Glucose-6-phosphate dehydrogenase deficiency.
  • Known allergy to dapsone.
  • Concurrent Medication:
  • Excluded:
  • Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
  • Patients with the following prior conditions are excluded:
  • Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
  • Prior Medication:
  • Excluded:
  • Prior dapsone.
  • Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry.
  • TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving).
  • Prior Treatment:
  • Excluded:
  • RBC transfusion within 4 weeks prior to study entry.

Attachments

readout_NCT00000739_2024-05-23.pdf

4.5 MB

NCT00000739_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

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Worcester, Massachusetts, United States

New Brunswick, New Jersey, United States

Brooklyn, New York, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Long Beach, California, United States

Los Angeles, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Washington, District Of Columbia, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

Paterson, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Norfolk, Virginia, United States

Seattle, Washington, United States

Bayamon, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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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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