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

HIV comorbidities and complications

You are being asked to take part in this research study because you are infected with HIV, the virus that causes AIDS, and were previously followed in the ALLRT (A5001) study and are 40 years of age or older. This study, A5322 (also known as the HAILO study), is a long-term follow-up study of persons who have HIV and received their first treatment for HIV known as antiretroviral medications, in certain clinical trials that were done by the AIDS Clinical Trials Group (ACTG).

 

The purpose of this study is to help us learn about how HIV , aging and the immune system (how your body fights infection) all interact with each other to see how they relate to the development of illnesses such as kidney disease, cancer, and diabetes. This study will also see if treating people with HIV for these otherillnesses works as well as treating people without HIV for the same illness.

 

-PersonsParticipants 40 years of age and older who werebeing actively followed in the ALLRT (A5001), or recently completed follow-up in ALLRT, at the time of enrollment in A5322.

-Received their first HIV treatment in an ACTG protocol and then enrolled intothe ALLRT parent protocol.

-Eligible participantspartcipants must agree to be followed long-term to observe the aging process and for outcomes known as endpoints that are either clinical (you have a disease or health problem), virologic (meaning how your HIV responds to treatment) or  immunologic (meaning how your immune system reacts)while taking long-term treatment with HIV medicine.

-Planned enrollment to include approximately 22% female participantssex participants (corresponding to the

proportion of female sex participantsparticipants aged 40 years and older being followed in the ALLRT study).

-Ability to commit to the long-term study requirements.

 

Treatment for HIV must be arranged outside of the A5322 protocol. No treatment is given through the A5322 protocol.

Participants will be followed for 366 weeks (7 years).

Special Testing:

-As in ALLRT, participants will have the Neuroscreen at entry into A5322 and every 48 weeks thereafter.  This includes both Neurocognitive testing (i.e., digit symbol, HVLT-revised) and Neuropathy testing (i.e., tendon reflexes and vibratory sensation testing). -In addition, there will be a frailty assessment which will be performed for all participants enrolled in A5322. This consists of a hand grip assessment (measure of hand strength) followed by a 4-meter timed walk , along with several interviewer-administered questions on weight loss, physical activity and exhaustion.

-Participation in A5322’s substudy (A5323s: Inflammation in the Functional Capacity: Trajectory of those Aging with HIV-Infection [FIT Substudy]) which is Optional. Participants enrolled in both A5322 and A5323s will complete the entire physical function battery which is detailed below:

Grip Strength (A5322 and A5323s)

4-meter Walk (A5322 and A5323s)

Single Chair Rise (A5323s only)

Repeated Chair Stands (A5323s only)

Standing Balance Test (A5323s only)

400-meter Walk (A5323s only)