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: 6122856
• 负责人: RAYMOND C BAKER
• 金额: $ 3.03万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6122856
• 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II/III期比较性、多中心试验， 拉米夫定联合治疗HIV-1感染儿童的疗效比较 齐多夫定对比去羟肌苷单药治疗对比齐多夫定加去羟肌苷。 结果由HIV疾病进展确定，基于至 第一个新的CDC C类诊断的发展，死亡， 达到足够的体重增长速度，或神经系统或 神经心理学评估 这项研究正式结束于 1997年6月在辛辛那提。 失去国家卫生研究院的资助意味着 该机构在前四年处于研究的收尾阶段， 1997年的月份。 本试验尚未发表任何文献。 之前在辛辛那提入组ACTG试验的所有患者 儿童医院被转移到哥伦布儿童医院， 它仍然是ACTG的成员。