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