Title
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
Phase
Phase 1Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Pneumonia, Pneumocystis Carinii HIV InfectionsIntervention/Treatment
pentamidine ...Study Participants
32Primary: 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.
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.
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).
