A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Pentamidine isethionate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Van Dyke R, Study Chair
Pramberg J, Study Chair
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 oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of
these regimens in this patient population.
Secondary: To obtain information on the rate of PCP breakthrough in infants and children
receiving parenteral pentamidine prophylaxis.
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 - sulfamethoxazole, parenteral pentamidine may be a successful
alternative.
Clinical Details
Official title: A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
Study design: Treatment
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 - sulfamethoxazole, parenteral pentamidine may be a successful
alternative.
Thirty-two children are randomized to one of two treatment arms. Patients receive
pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until
the last child enrolled has received at least 6 months of pentamidine. Patients are
stratified according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics
will be examined in a subsample of 20 patients.
Eligibility
Minimum age: 1 Month.
Maximum age: 6 Years.
Gender(s): Both.
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).
Locations and Contacts
San Juan City Hosp, San Juan 009367344, Puerto Rico
Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham, Alabama 35294, United States
UCLA Med Ctr / Pediatric, Los Angeles, California 900951752, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Children's Hosp of Denver, Denver, Colorado 802181088, United States
Howard Univ Hosp, Washington, District of Columbia 20060, United States
Children's Hosp of Washington DC, Washington, District of Columbia 200102916, United States
Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States
Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark, New Jersey 071072198, United States
Harlem Hosp Ctr, New York, New York 10037, United States
Cornell Univ Med College, New York, New York 10021, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo, Buffalo, New York 14222, United States
Beth Israel Med Ctr / Pediatrics, New York, New York 10003, United States
Additional Information
Click here for more information about Pentamidine isethionate
Last updated: June 23, 2005
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