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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole

Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population.

Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.

Study Type

Interventional

Enrollment

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
      • San Juan, Puerto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Usc La Nichd Crs
      • Los Angeles, California, United States, 90095
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland, California, United States
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Med. Ctr., ACTU
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Chicago Children's CRS
      • Chicago, Illinois, United States, 60637
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane/LSU Maternal/Child CRS
    • New York
      • New York, New York, United States, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, United States, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • Syracuse, New York, United States
        • SUNY Upstate Med. Univ., Dept. of Peds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Fujisawa Pharmaceutical Co

Investigators

  • Study Chair: Pramberg J

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 1996

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 189
  • 11164 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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