A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
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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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | September 1996 |
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 |
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| United States, California | |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | |
| Los Angeles, California, United States, 90095 | |
| Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy | |
| Los Angeles, California, United States, 90027 | |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | |
| Oakland, California, United States, 94609 | |
| United States, Texas | |
| Texas Children's Hosp. CRS | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | YJ Bryson | |
| Study Chair: | ER Stiehm | |
| Study Chair: | B Montgomery |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000974 History of Changes |
| Other Study ID Numbers: | ACTG 115, 11090 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 28, 2012 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Pentamidine Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Trypanocidal Agents |
ClinicalTrials.gov processed this record on June 17, 2013