Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 46
研究概览
简要总结
Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children.
Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone.
Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.
详细描述
Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.
Ninety-six HIV-infected infants and children who are intolerant to trimethoprim / sulfamethoxazole ( TMP / SMX ) are randomized to receive oral dapsone in a lower dose once daily or at a higher dose once weekly. Treatment continues until the last patient enrolled has received at least 3 months of therapy. Blood samples are drawn between weeks 4 and 8, at weeks 12 and 24, and every 3 months thereafter during dapsone administration.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Rifampin and rifampin derivatives for up to 1 week during the study.
- •Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician).
- •Patients must have:
- •Evidence of HIV infection.
- •PER AMENDMENT 11/16/95:
- •Children who require prophylaxis. (Was written - Risk of developing PCP.)
- •Known intolerance to TMP / SMX.
- •Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Glucose-6-phosphate dehydrogenase deficiency.
- •Known allergy to dapsone.
- •Concurrent Medication:
- •Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
- •Patients with the following prior conditions are excluded:
- •Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
- •Prior Medication:
- •Prior dapsone.
- •Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry.
- •TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving).
- •Prior Treatment:
- •RBC transfusion within 4 weeks prior to study entry.