RANDOMIZED STUDY OF ATOVAQUONE AND AZITHROMYCIN AS COMPARED TO TMP/SMZ

阿托伐醌和阿奇霉素与 TMP/SMZ 的随机研究

• 批准号: 6220566
• 负责人: Kenneth McIntosh
• 金额: $ 0.07万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6220566
• 关键词: AIDS therapy; Pneumocystis carinii; Pneumocystis pneumonia; antibacterial agents; antiprotozoal agents; atovaquone; azithromycin; bacterial disease; clinical research; clinical trials; combination chemotherapy; disease /disorder prevention /control; drug screening /evaluation; human subject; human therapy evaluation; infection; naphthoquinones; sulfamethoxazole; trimethoprim

Phase II/III, randomized, placebo-controlled, two-armed, comparison AIDS Clinical Trial Group (ACTG) study. Two important criteria for establishing an AIDS diagnosis in those with HIV infection are the development of an opportunistic infection and the presence of recurrent or multiple serious bacterial infections. Pneumocystis carinii pneumonia (PCP) is the most common opportunistic infection reported in children and has accounted for >40% of all AIDS defining illnesses in this age group. The primary aims of the study are to determine the comparability of azithromycin plus atovaquone to trimethoprim/sulfamethoxazole (TMP/SMX) in the prevention of serious bacterial infections and to determine and compare the long-term safety and tolerance of micronized atovaquone plus azithromycin versus TMP/SMX.

II/III期，随机，安慰剂对照，双臂，比较艾滋病临床试验组（ACTG）研究。在艾滋病毒感染者中确定艾滋病诊断的两个重要标准是机会性感染的发展和复发性或多重严重细菌感染的存在。卡氏肺囊虫肺炎（PCP）是儿童中最常见的机会性感染，占该年龄组所有艾滋病定义疾病的40%。本研究的主要目的是确定阿奇霉素加阿托瓦酮与甲氧苄啶/磺胺甲恶唑（TMP/SMX）在预防严重细菌感染方面的可比性，并确定和比较微粉阿托瓦酮加阿奇霉素与TMP/SMX的长期安全性和耐受性。