PENTAMIDINE FOR PNEUMOCYSTIS IN MEN, WOMEN, AND CHILDREN
Project Number2R01AI026344-03A1
Contact PI/Project LeaderCONTE, JOHN E
Awardee OrganizationUNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Description
Abstract Text
The goal of this research is to improve our understanding of the treatment
and prevention of Pneumocystis carinii pneumonia (PCP) in men, women and
children with HIV 1 infection. The specific objectives are to study: 1)
the efficacy, toxicity, and pharmacokinetics of high dose, aerosolized
pentamidine prophylaxis in adult patients, 2) the pharmacokinetics of
parenteral pentamidine in asymptomatic, HIV 1 infected men and women who
are at risk for the development of PCP, 3) the pharmacokinetics of
prophylactic aerosolized and parenteral pentamidine in asymptomatic, HIV 1
infected children, 4) the pharmacokinetics of parenteral pentamidine in
children who are being treated for acute PCP.
In the adult study, 150 patients will receive either 600 mg once-monthly or
300 mg once-monthly (double-blind) of aerosolized pentamidine prophylaxis.
End point analysis includes occurrence of PCP, toxicity and death. In a
subset of 20 of these patients, an intensive study of toxicity and
pharmacokinetics will be carried out using serial pulmonary function
testing and measurement of pentamidine concentration in bronchoalveolar
lavage fluid and plasma.
The pharmacokinetics of pentamidine will be studied in an additional 80
individuals in the following categories: Group 1: 15 women who are being
treated for PCP with intravenous pentamidine, Group 2: 10 volunteer,
asymptomatic HIV+ women who are at risk for PCP, Group 3: 10 volunteer
asymptomatic HIV men (control group) who are at risk for PCP, Group 4: 15
children, age < 13 years, who are receiving treatment for PCP with
intravenous pentamidine, Group 5: 15 asymptomatic HIV+ children who are
receiving once monthly intravenous prophylaxis, Group 6: 15 HIV+
asymptomatic children who are receiving once monthly aerosolized
prophylaxis for pentamidine. Serial blood and urine specimens will be
obtained according to the enclosed protocols, pentamidine will be assayed
using high performance liquid chromatography, and the kinetics will be
calculated using standard modelling techniques.
National Institute of Allergy and Infectious Diseases
CFDA Code
DUNS Number
094878337
UEI
KMH5K9V7S518
Project Start Date
01-July-1989
Project End Date
31-March-1995
Budget Start Date
01-April-1992
Budget End Date
31-March-1993
Project Funding Information for 1992
Total Funding
$254,814
Direct Costs
$214,934
Indirect Costs
$39,880
Year
Funding IC
FY Total Cost by IC
1992
National Institute of Allergy and Infectious Diseases
$254,814
Year
Funding IC
FY Total Cost by IC
Sub Projects
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