ATN 061 Category B Diagnoses 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 HIV and Non-HIV Diagnoses Form [CRF 5, question 3: Category B diagnoses]
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

数据来源于HIV与非HIV诊断表单[病例报告表5（CRF 5），问题3：B类诊断]
研究概况
本研究为针对18至24岁青少年与青年群体的概念验证随机对照试验，受试者为9岁后确诊感染HIV且CD4+T淋巴细胞（CD4+ T cells）计数高于350个/mm³的人群，按3:1的比例随机分组：入组时即启动高活性抗逆转录病毒治疗（HAART），治疗方案包括首选的TDF/FTC/ATV/r、AZT/3TC/ATV/r，或其他推荐的以核苷类反转录酶抑制剂（NRTI）为骨架联合ATV/r的方案。实验组受试者若在第24周达到病毒学控制，并在第48周仍维持良好病毒学控制，则可降级为仅使用ATV/r单药治疗，并继续接受为期两年的随访。
被分配至标准治疗组的受试者，初始采用TDF/FTC/ATV/r、AZT/3TC/ATV/r或其他基于ATV/r的推荐HAART方案，总随访时长为三年。当标准治疗组受试者的CD4+T淋巴细胞计数降至350个/mm³以下，或符合由研究中心医师判定的其他需启动治疗的临床指征时，将开始抗逆转录病毒治疗。
本研究可提供部分生物标本；如有咨询需求，请联系John Sleasman博士（邮箱：[e-mail]）。
18至24岁、9岁后确诊感染HIV的青少年与青年群体