LONG-TERM ADMINISTRATION OF AEROSOLIZED PENTAMIDINE AS PRIMARY PROPHYLAXIS AGAINST PNEUMOCYSTIS-CARINII PNEUMONIA IN INFANTS AND CHILDREN WITH SYMPTOMATIC HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

We assessed the long-term feasibility, safety, and tolerability of two regimens of aerosolized pentamidine (AP) as primary prophylaxis of Pn eumocystis carinii pneumonia (PCP) in a large sample of infants and ch ildren with symptomatic HIV infection in 21 pediatric departments. One hundred forty children were assigned to receive 60 mg every 2 weeks ( n = 60) or 120 mg every 4 weeks (n = 80) of AP, delivered by the ultra sonic nebulizer Fisoneb under the supervision of trained personnel. Ch ildren underwent monthly clinical and laboratory controls for toxicity and/or development of PCP for an 18-month period. Baseline characteri stics were similar in the two treatment groups. The median age was 5 y ears. The feasibility of administering AP was excellent in 84 (60%) an d good in 38 (27%) children, All children aged <2 years showed excelle nt or good feasibility. Long-term compliance was good with both regime ns. No child had severe adverse reactions requiring discontinuation of the treatment. Cough, sneezing, and bronchospasm were the most freque nt side effects occurring, respectively, in 12, 3.7, and 0.7% of the 6 0-mg treatments and in 19.1, 6.1, and 2.8% of 120-mg treatments (p < 0 .05). Their incidence was not different in children younger or older t han 5 years. Two episodes of PCP were observed in the group receiving 120 mg monthly, whereas none of the 60 children in the biweekly schedu le had PCP (p = 0.20), AP can be safely administered to very young chi ldren with few adverse effects.