Status:
COMPLETED
A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
2-13 years
Phase:
PHASE1
Brief 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 pharmac...
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 -...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00000974
End Date
September 1 1996
Last Update
November 1 2021
Active Locations (4)
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1
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States, 90027
2
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095
3
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
4
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030