A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
Status:
Completed
Trial end date:
1996-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)