A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation (HAILO)

DESIGN: The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an established longitudinal study of participants living with HIV. At the time of enrollment in A5322, these participants were enrolled and followed in the Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) study (A5001) (or had recently completed follow-up in ALLRT [A5001]), which had enrolled participants who received their first immune-based or antiretroviral therapies (ART) or treatment strategies through randomized ACTG clinical trials. These participants will be followed for the purposes of evaluating clinical, virologic, and immunologic outcomes and their potential associations with long-term treatment with potent ART and aging. DURATION: Participants will be followed for 336 weeks (~7 years). SAMPLE SIZE: Closed to accrual on July 31, 2014; 1035 evaluable participants were entered into the study. POPULATION: Participants actively followed in the ALLRT (A5001) at the time of enrollment into A5322 or completed follow-up in ALLRT (A5001) and enrolled into A5322 no later than July 31, 2014, who were ART-naïve at the time of enrollment into their ALLRT (A5001) parent protocol, and who were 40 years of age or older at their time of enrollment into A5322. Eligible participants must agree to be followed long-term for clinical, virologic, and immunologic outcomes. Planned enrollment included approximately 22% female participants (corresponding to the proportion of A5322-eligible female participants) aged 40 years and older who were being followed in ALLRT (A5001). REGIMEN: Treatment for HIV infection must be arranged independently of the A5322 protocol. No treatment is provided through the A5322 protocol

【研究设计】A5322方案为一项长期观察性研究，计划对一项既定的人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）感染者纵向研究的采集数据开展系列分析。在入组A5322研究时，受试者已参与成人艾滋病临床试验组（Adult AIDS Clinical Trials Group, ACTG）纵向关联随机试验（Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials, ALLRT，即A5001研究）并接受随访，或刚完成ALLRT（A5001）的随访；ALLRT研究的入组对象为通过ACTG随机临床试验接受首次免疫治疗或抗反转录病毒疗法（antiretroviral therapy, ART）或治疗方案的受试者。本研究将对受试者进行随访，以评估临床、病毒学及免疫学结局，及其与强效抗反转录病毒疗法长期治疗和衰老的潜在关联。
【研究周期】受试者的随访周期为336周（约7年）。
【样本量】本研究于2014年7月31日停止入组，最终纳入1035名可评估受试者。
【研究人群】在A5322研究入组时仍在ALLRT（A5001）中接受主动随访的受试者，或已完成ALLRT（A5001）随访且不晚于2014年7月31日入组A5322研究的受试者；且这些受试者在入组其母研究ALLRT（A5001）时未接受过抗反转录病毒治疗，并在入组A5322研究时年满40周岁。符合入组条件的受试者需同意长期接受临床、病毒学及免疫学结局随访。本研究计划入组的女性受试者占比约22%，该比例对应ALLRT（A5001）随访队列中符合A5322入组条件的40岁及以上女性受试者占比。
【治疗方案】HIV感染的治疗需独立于A5322研究方案安排，A5322研究不提供任何治疗干预。