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A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Pentamidine isethionate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
YJ Bryson, Study Chair
ER Stiehm, Study Chair
B Montgomery, Study Chair

Summary

To evaluate the delivery of a single dose of aerosolized pentamidine to children; to evaluate the tolerance of pentamidine administration by mask; to compare intravenous pentamidine first dose pharmacokinetics (blood levels) in children with information previously collected on adults; and to compare plasma pentamidine levels in children after an aerosolized treatment with levels previously collected on adults. Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with AIDS and is associated with a high death rate. Current approved treatment includes

intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which

are both effective in treatment of the first episode of PCP pneumonia. However, both therapies have a 50 percent or greater incidence of adverse reactions. Because of serious toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized pentamidine (pentamidine given through inhalation) is as effective as intravenous pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous pentamidine. The study is the first step in evaluating the delivery of aerosolized pentamidine to children.

Clinical Details

Official title: A Phase I Study of the Safety, Tolerance, and Study of the Pharmacokinetics of Aerosolized Pentamidine and Parenteral Pentamidine in Children With HIV Infection and Suspected Pneumocystis Carinii Pneumonia

Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Detailed description: Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with AIDS and is associated with a high death rate. Current approved treatment includes

intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which

are both effective in treatment of the first episode of PCP pneumonia. However, both therapies have a 50 percent or greater incidence of adverse reactions. Because of serious toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized pentamidine (pentamidine given through inhalation) is as effective as intravenous pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous pentamidine. The study is the first step in evaluating the delivery of aerosolized pentamidine to children. Sixteen patients are assigned into one of the following groups. Group 1 (four patients) receives intravenous pentamidine as a one-time dose, infused over 2 hours. Group 2a (six patients) receives aerosolized pentamidine via face mask. Group 2b (six patients) receives aerosolized pentamidine 2 times. Group 2b will be studied only if initial dose is well

tolerated. Small amounts (1 - 2 cubic centimeters) of blood is taken from all groups at 40

minutes, and 2, 3, 7, 14, and 24 hours from the beginning of pentamidine treatment and at the same time as the lung biopsy or bronchial alveolar lavage. Patients are given routine TMP / SMX (or whatever medications are considered appropriate by the patient's primary

physician for medical management) dosing 1 - 2 hours after pentamidine is given. Bronchial

alveolar lavage fluid or lung tissue from biopsy will be obtained between 2 - 48 hours after

initiation of pentamidine treatment (optionally 10 - 24 hours post dose).

Eligibility

Minimum age: 2 Months. Maximum age: 13 Years. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Allowed:

- Routine trimethoprim / sulfamethoxazole (TMP / SMX) (or whatever medications are

considered appropriate by the patient's primary physician for medical management) 1 -

2 hours after pentamidine is given. Patients must have:

- HIV infection with suspected Pneumocystis carinii pneumonia (PCP).

- Parent(s) or legal guardian must sign an informed consent.

Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:

- Known history of reactive airway disease or another chronic lung disease.

- Known previous adverse reaction to pentamidine.

- Thrombocytopenia.

Patients with the following are excluded:

- History of reactive airway disease or another chronic lung disease.

- Known previous adverse reaction to pentamidine.

Unable to cooperate with administration of aerosol via face mask.

Locations and Contacts

Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy, Los Angeles, California 90027, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California 90095, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California 94609, United States

Texas Children's Hosp. CRS, Houston, Texas 77030, United States

Additional Information

Click here for more information about Pentamidine isethionate

Related publications:

Conte JE Jr; Wara D. Pharmacokinetics of aerosolized pentamidine in children. Int Conf AIDS. 1993 Jun 6-11;9(1):381 (abstract no PO-B10-1477)

Kreuz W, Gunguor T, Funk M, Ehrenforth S, Linde R, Lotz C, Kornhuber B. First experience with Pneumocystis carinii pneumonia-prophylaxis by inhaled pentamidine in HIV-infected children. Int Conf AIDS. 1991 Jun 16-21;7(2):242 (abstract no WB2243)


Last updated: March 28, 2012

Page last updated: August 23, 2015

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