ATN 061 Urinalysis and Urine Pregnancy Results Explanation Dataset in Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 cells/mm3 Initiating HAART

Data from Urinalysis and Pregnancy Results Form [CRF 14, reasons sample not collected table, version 1]
Study Description
A randomized, proof-of-concept study of adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9 with CD4+ T cells above 350 cells/mm3 who were randomized 3:1 to begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone with ATV/r upon entry. Subjects in the experimental group who achieved virologic control by week 24 and maintained good control through 48 weeks would de-intensify to ATV/r alone and be followed for an additional two years. Subjects randomized to the standard care arm began HAART with TDF/FTC/ATV/r, AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen and followed for a total of three years. Subjects on the standard care arm would begin therapy when the CD4+ T cell count dropped below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman ([e-mail]). Adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9

尿液分析与妊娠结果表单（病例报告表Case Report Form, CRF 14：未采集样本原因表，版本1）数据

研究概况
本研究为一项随机、概念验证性研究，纳入对象为18~24岁的青少年及青年成人，均经确认于9岁后感染人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV），且外周血CD4+T淋巴细胞计数＞350个/mm³；受试者按3:1比例随机分组，入组时即启动高效抗反转录病毒治疗（Highly Active Antiretroviral Therapy, HAART），治疗方案包括首选的TDF/FTC/ATV/r、AZT/3TC/ATV/r，或其他推荐的以ATV/r为基础的核苷类反转录酶抑制剂（Nucleoside Reverse Transcriptase Inhibitor, NRTI）联合方案。
试验组受试者若在第24周达到病毒学控制，且维持至第48周病情控制良好，则可降阶为仅服用ATV/r的单药方案，并追加随访两年。
随机分配至标准治疗组的受试者，入组时即采用TDF/FTC/ATV/r、AZT/3TC/ATV/r或其他推荐的以ATV/r为基础的HAART方案，并接受总计三年的随访。
标准治疗组受试者将在其CD4+T淋巴细胞计数降至350个/mm³以下，或由研究中心临床医师判定存在其他需启动治疗的临床指征时，开始抗反转录病毒治疗。
本研究留存部分生物样本；若有咨询需求，请联系约翰·斯利斯曼博士（[e-mail]）。
18~24岁、经确认于9岁后感染HIV的青少年及青年成人