Status:
COMPLETED
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Fujisawa Pharmaceutical Co
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
1-6 years
Phase:
PHASE1
Brief Summary
Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to ora...
Detailed Description
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim ...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Steroids and intravenous immune globulin (IVIG).
Patients must have:
- Documented HIV infection.
- Need for PCP prophylaxis.
- Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).
One of the following required conditions:
- Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179.
NOTE:
- Co-enrollment in other ACTG pediatric studies is permitted.
Consent of parent or guardian is required.
Prior Medication:
Allowed:
- Prior pentamidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Active PCP.
- Pancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal.
Prior Medication:
Excluded:
- TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00001027
End Date
September 1 1996
Last Update
November 1 2021
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Usc La Nichd Crs
Los Angeles, California, United States, 90033
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
4
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States, 20010