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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000974 |
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 |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
Phase I |
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 |
Estimated Enrollment: | 16 |
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).
Ages Eligible for Study: | 2 Months to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Unable to cooperate with administration of aerosol via face mask.
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 |
Study Chair: | YJ Bryson | |
Study Chair: | ER Stiehm | |
Study Chair: | B Montgomery |
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 |
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Injections, Intravenous |
Drug Evaluation Aerosols Acquired Immunodeficiency Syndrome |
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 |
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 |