PHASE II AND III COMPARATIVE STUDY OF THERAPIES IN HIV 1 INFECTED CHILDREN

HIV 1 感染儿童治疗的 II 期和 III 期比较研究

• 批准号: 6282862
• 负责人: RAYMOND C BAKER
• 金额: $ 2.34万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 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/6282862
• 关键词: 2'3' dideoxyinosine; AIDS therapy; antiAIDS agent; child (0-11); clinical research; combination chemotherapy; drug screening /evaluation; human immunodeficiency virus 1; human subject; human therapy evaluation; lamivudine; pediatric AIDS; zidovudine

This is a Phase II/III comparative, multi-center trial of symptomatic HIV-1-infected children comparing the efficacy of lamivudine plus zidovudine vs. didanosine monotherapy vs. zidovudine plus didanosine. Results are determined by HIV disease progression based on time to development of first new CDC category C diagnoses, death, failure to achieve adequate weight growth velocity, or decline in neurological or neuropsychological assessments. This study was officially closed at Cincinnati in June 1997. The loss of NIH funding meant that our institution was in a close-out phase of the study for the first four months of 1997. No publications have as yet resulted from this trial. All patients who were previously enrolled in the ACTG trial at Cincinnati Children's Hospital were transferred to Columbus Children's Hospital, which remains a member of the ACTG.

这是一项针对症状的 II/III 期比较、多中心试验 HIV-1 感染儿童比较拉米夫定联合用药的疗效 齐多夫定与去羟肌苷单一疗法对比齐多夫定加去羟肌苷。 结果由基于治疗时间的 HIV 疾病进展决定 开发第一个新的 CDC C 类诊断、死亡、未能 达到足够的体重增长速度，或神经系统或功能下降 神经心理学评估。 这项研究正式结束于 1997 年 6 月，辛辛那提。 NIH 资金的损失意味着我们的 该机构前四个项目正处于研究收尾阶段 1997 年几个月。该试验尚未有任何出版物发表。 所有之前参加辛辛那提 ACTG 试验的患者 儿童医院转移至哥伦布儿童医院， 仍然是 ACTG 的成员。