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: 6282225
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 1.97万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282225
• 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 liklihood of pharmacokinetic interaction between atovaquone and azithromycin in a subset of two to 18 year old patients.

卡氏肺孢子虫肺炎（PCP）是最常见的机会性肺炎。 感染艾滋病毒的儿童中报告的感染情况。而甲氧苄啶- 磺胺甲恶唑（TMP/SMX）仍然是治疗PCP的首选药物 预防，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）的疗效 和pentamidine-尚未确定在婴儿和儿童。 阿托伐醌，一种只需要每天服用一次的口服药物， 已证明对卡氏肺孢子虫和刚地弓形虫具有活性， 已被证明是安全的，没有明确的不良或毒性 方面的影响.这一多中心、两支武装、双 盲态、安慰剂对照研究将比较TMP/SMX和AT/AZ， 严重细菌感染的预防;确定和比较 长期安全性和耐受性;并评估 阿托伐醌与阿奇霉素的药动学相互作用 2至18岁患者的子集。