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A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000974
  Purpose

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.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Pentamidine isethionate
Phase I

MedlinePlus related topics: AIDS Pneumonia
Drug Information available for: Pentamidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 16
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

Ages Eligible for Study:   2 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000974

Locations
United States, California
Children's Hosp of Oakland
Oakland, California, United States, 946091809
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: YJ Bryson
Study Chair: ER Stiehm
Study Chair: B Montgomery
  More Information

Click here for more information about Pentamidine isethionate  This link exits the ClinicalTrials.gov site

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)

Study ID Numbers: ACTG 115
Study First Received: November 2, 1999
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00000974  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Injections, Intravenous
Drug Evaluation
Aerosols
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Clotrimazole
Pneumocystosis
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Pentamidine
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Trypanocidal Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Immune System Diseases
Infection
Pharmacologic Actions
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 15, 2009