PEDIATRIC AIDS CLINICAL TRIALS UNIT

儿科艾滋病临床试验单位

• 批准号: 3548009
• 负责人: Jane L. Burns
• 金额: $ 64.91万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-04-01 至 1997-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3548009
• 关键词: AIDS; AIDS therapy; child (0-11); clinical trials; congenital infection; cooperative study; human immunodeficiency virus 1; human pregnant subject; human subject; human therapy evaluation; nervous system infection; opportunistic infections; pediatric AIDS; virus related neoplasm /cancer; zidovudine

The goal of the University of Washington (UW) pediatric ACTU faculty is to perform exemplary HIV/AIDS treatment research in outpatients and inpatients as part of the national multicenter AIDS Clinical Trials Group (ACTG). The UW Pediatric ACTU's specific aims are to conduct Phase I, II and III studies in these areas: 1) primary pediatric infection; 2) opportunistic infections; and 3) perinatal trials. An additional aim is conduct of studies of opportunistic infections, especially genital infections with potential complications such as cervical cancer in women. We have an established investigative team including pediatrics, obstetrics, gynecology and internal medicine, experienced in performing antiviral and other clinical trials in pregnant women, infants and children. The UW is the referral center for a five-state region of the Pacific Northwest for HIV in children and pregnant women, and has followed 90 children and over 70% of the HIV seropositive pregnant women in this region. The states of Washington and Oregon have experienced a 40% increase in HIV seroprevalence in pregnant women from 1989 to 1990, and this increase has occurred mainly in ethnic minorities. Total minority numbers are 36% African American, 21 % Native American, 3% Hispanic and 2% Asian. We have established the Northwest Family Center (NWFC), a "one-stop-shopping" facility with a multicultural staff to provide clinical care, social support and access to ACTG clinical trials. As substance abuse was the mechanism of HIV infection in 80% of seropositive pregnant women, NWFC has co-located with a treatment program for chemically dependent pregnant women. We have the infrastructure to enroll and retain HIV infected pregnant women and their infants, as well as HIV infected children, on ACTG protocols in a culturally sensitive fashion. We will enroll at least 35 HIV infected pregnant women and their infants as well as 28 HIV infected children per year in clinical trials. This proposal seeks funding to achieve independent status as a Pediatric ACTU and establishment of the Oregon Subunit.

华盛顿大学 (UW) 儿科 ACTU 教师的目标是 在门诊患者中进行示范性艾滋病毒/艾滋病治疗研究 作为国家多中心艾滋病临床试验组一部分的住院患者 （ACTG）。 华盛顿大学儿科 ACTU 的具体目标是进行 I、II 阶段 III 这些领域的研究：1）原发性儿科感染； 2） 机会性感染； 3) 围产期试验。 另一个目标是 进行机会性感染，特别是生殖器感染的研究 女性感染宫颈癌等潜在并发症。 我们拥有一支成熟的调查团队，包括儿科、 产科、妇科、内科，执行经验丰富 针对孕妇、婴儿和儿童的抗病毒和其他临床试验 孩子们。 华盛顿大学是美国五个州地区的转诊中心 太平洋西北地区针对儿童和孕妇的艾滋病毒，并已 跟踪了 90 名儿童和超过 70% 的 HIV 血清阳性孕妇 在这个地区。 华盛顿州和俄勒冈州经历了 1989 年至 1990 年间，孕妇的艾滋病毒血清阳性率增加了 40% 这种增长主要发生在少数民族中。 全部的 少数族裔人数为 36% 非裔美国人、21% 美洲原住民、3% 西班牙裔和 2% 亚裔。 我们成立了西北家庭中心 (NWFC)，一个拥有多元文化员工的“一站式购物”设施 提供临床护理、社会支持和参加 ACTG 临床试验的机会。 由于药物滥用是 80% 的人感染 HIV 的机制 血清反应呈阳性的孕妇，NWFC 与治疗计划位于同一地点 对于化学依赖性孕妇。 我们拥有基础设施 招募并留住感染艾滋病毒的孕妇及其婴儿 作为艾滋病毒感染儿童，在文化敏感的情况下接受 ACTG 方案 时尚。 我们将招募至少 35 名感染艾滋病毒的孕妇 他们的婴儿以及每年 28 名 HIV 感染儿童在临床中 试验。 该提案寻求资金以实现独立地位 儿科 ACTU 和俄勒冈亚单位的建立。