Search / Trial NCT00001027

A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

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

Pneumonia, Pneumocystis Carinii Pentamidine Acquired Immunodeficiency Syndrome Aids Related Complex

Description

Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative. Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age < 24 months or age >= 24 months. S...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Steroids and intravenous immune globulin (IVIG).
  • Patients must have:
  • Documented HIV infection.
  • Need for PCP prophylaxis.
  • Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).
  • One of the following required conditions:
  • Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179.
  • NOTE:
  • Co-enrollment in other ACTG pediatric studies is permitted.
  • Consent of parent or guardian is required.
  • Prior Medication:
  • Allowed:
  • Prior pentamidine.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Active PCP.
  • Pancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal.
  • Prior Medication:
  • Excluded:
  • TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).

Attachments

readout_NCT00001027_2024-07-23.pdf

4.5 MB

NCT00001027_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

New Orleans, Louisiana, United States

New York, New York, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

New York, New York, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Los Angeles, California, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

Syracuse, New York, 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

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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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