ACTG 273--PHASE I/II STUDY OF HIVIG IN SLOWING PROGRESSION OF DISEASE

ACTG 273--HIVIG 减缓疾病进展的 I/II 期研究

• 批准号: 6282691
• 负责人: Peter James Krause
• 金额: $ 1.85万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 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 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282691
• 关键词: AIDS therapy; antiviral antibody; child (0-11); clinical research; clinical trial phase I; human immunodeficiency virus; human subject; human therapy evaluation; immunoglobulin G; pathologic process; pediatric AIDS

This is a Phase I study of HIV-infected subjects age 2-12 years, who have been maintained on antiretroviral therapy for > 6 months, whose CD4 count is > 200 were given HIVIG, randomized to 1 of 3 doses. Six monthly infusions were given, then a 3 month, and monthly follow-up visits. The objectives of this study are to evaluate the safety and tolerance; evaluate dosage by serial measurements of IgG, P-24 antigen and rubella antibody titers; and to evaluate antiviral activity of HIVIG by assays of viral burden. The study has been closed.

这是一项针对 2-12 岁 HIV 感染者的 I 期研究，他们 已维持抗逆转录病毒治疗> 6个月，其CD4 计数 > 200 人接受了 HIVIG，随机分配到 3 剂中的 1 剂。 六 每月进行一次输注，然后进行 3 个月和每月一次的随访 访问。 本研究的目的是评估安全性和 宽容;通过连续测量 IgG、P-24 抗原来评估剂量 和风疹抗体滴度；并评估 HIVIG 的抗病毒活性 通过病毒负荷测定。 该研究已结束。