A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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....

Gender

ALL

Eligibility 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).