ACTG 254--PHASE II/III STUDY OF AT/AZ AS COMPARED TO TMP/SMX IN CHILDREN

ACTG 254--AT/AZ 与 TMP/SMX 在儿童中的 II/III 期研究

• 批准号: 6309602
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309602
• 关键词: Pneumocystis carinii; Pneumocystis pneumonia; adolescence (12-20); antiprotozoal agents; atovaquone; azithromycin; chemoprevention; child (0-11); clinical research; communicable disease control; drug interactions; drug screening /evaluation; human subject; human therapy evaluation; microorganism disease chemotherapy; opportunistic infections; pediatric AIDS; sulfamethoxazole; trimethoprim

Pneumocystis carinii pneumonia (PCP) is the most common opportunistic infection reported in HIV-infected children. While trimethoprim-sulfamethoxazole (TMP/SMX) remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its effective use; in addition, the efficacy of the most common alternative therapies-including dapsone and pentamidine has yet to be determined in infants and children. Atovaquone, an oral medication requiring only once daily administration, has demonstrated activity against P. carinii and Toxoplasma gondii, and has been shown to be both safe and with no defined adverse or toxic effects. Primary objectives of this multi-centered, two-armed, double blind, placebo controlled study will be to compare TMP/SMX and AT/AZ in the prevention of serious bacterial infections; determine and compare long-term safety and tolerance; and assess the likelihood of pharmacokinetic interaction between atovaquone and azithromycin in a subset of two to 18 year old patients.

卡氏肺囊虫肺炎（PCP）是hiv感染儿童中最常见的机会性感染。虽然甲氧苄啶-磺胺甲恶唑（TMP/SMX）仍然是PCP预防的首选药物，但药物敏感性可能限制其有效使用；此外，最常见的替代疗法——包括氨苯砜和喷他脒——对婴儿和儿童的疗效尚未确定。阿托伐醌是一种只需每天服用一次的口服药物，已被证明对卡氏弓形虫和弓形虫有活性，并且已被证明既安全又没有明确的不良或毒性作用。这项多中心、双臂、双盲、安慰剂对照研究的主要目的是比较TMP/SMX和AT/AZ预防严重细菌感染的效果；确定和比较长期安全性和耐受性；并评估阿托伐醌和阿奇霉素在2至18岁患者亚群中药代动力学相互作用的可能性。