A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
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Keep this study
Lead
National Institute of Allergy and Infectious Diseases (NIAID)
With
Fujisawa Pharmaceutical Co
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.
Age
0–6
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
Clareo Health | A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
