A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 13
研究概览
简要总结
Primary: 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •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
- •Co-enrollment in other ACTG pediatric studies is permitted.
- •Consent of parent or guardian is required.
- •Prior Medication:
- •Prior pentamidine.
排除标准
- •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:
- •TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).