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)
ClinicalTrials.gov processed this data on August 23, 2015 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: Primary Purpose: 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. PR NICHD CRS, San Juan 00936, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan, Puerto Rico
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California 90095, United States
Usc La Nichd Crs, Los Angeles, California 90033, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California, United States
Children's National Med. Ctr., ACTU, Washington, District of Columbia 20010, United States
Howard Univ. Washington DC NICHD CRS, Washington, District of Columbia 20060, United States
Chicago Children's CRS, Chicago, Illinois 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois 60637, United States
Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana 70112, United States
Harlem Hosp. Ctr. NY NICHD CRS, New York, New York 10037, United States
NYU Med. Ctr., Dept. of Medicine, New York, New York 10016, United States
SUNY Upstate Med. Univ., Dept. of Peds, Syracuse, New York, United States
Additional Information
Click here for more information about Pentamidine isethionate
Last updated: March 28, 2012
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