A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
NCT ID: NCT00001027
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Pentamidine isethionate
Eligibility Criteria
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Inclusion Criteria
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
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).
1 Month
6 Years
ALL
No
Sponsors
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Fujisawa Pharmaceutical Co
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Van Dyke R
Role: STUDY_CHAIR
Pramberg J
Role: STUDY_CHAIR
Locations
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Usc La Nichd Crs
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 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 D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Chicago Children's CRS
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds
Syracuse, New York, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11164
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 189
Identifier Type: -
Identifier Source: org_study_id