A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

Treatment Experienced, HIV Cure

AHRC (pronounced “ARC”) is a study of differences and changes over time in HIV reservoirs (groups of HIV-infected cells that “hide” from anti-HIV medications). This study enrolls people into one of six groups, based on their different HIV treatment histories. The current version of this study is only enrolling for Group 6, which will include people who acquired or are suspected to have acquired HIV while taking long-acting cabotegravir (LA CAB) for pre-exposure prophylaxis (PrEP).

• To try to answer questions about the ways that HIV infection is controlled.
• To see if there are differences in the size of the reservoir of HIV in people who acquire HIV while on LA CAB compared to other situations. This may additionally have to do with a person’s viral load and CD4 count, when they started their anti-HIV medications, and genetic factors.

• Living with HIV or with blood tests strongly suggesting HIV
• At least 18 years old
• Receipt of long-acting Cabotegravir (LA CAB) injection within 90 days before first reactive HIV test
• Have never had an HIV viral load >1500 copies/mL
• No active Hepatitis B or C infection
• Don’t have an autoimmune condition requiring steroid therapy
• Have not received any agent that is designed to affect the HIV reservoir (e.g., latency-reversing agent, broadly neutralizing antibodies)

Participants will attend visits every 12 weeks for the first 6 months on study, and then every 24 weeks, for a total time on study of approximately 6.5 years. Blood and a small amount of hair (if feasible) will be collected from participants at each visit.

 

Anti-HIV medications will not be supplied through this study.

Participants will be expected to stay in the study for about 7 years.

 

 

Longitudinal Sampling Substudy of A5321 is collecting information from measures of different HIV reservoirs, including where HIV can be found, whether different reservoirs have different amounts of HIV, the best way is to measure the amount of HIV in different reservoirs, and whether the amount of HIV found in one reservoir says anything about the amount of HIV in other reservoirs.

Why is this substudy, A5341s, being done?

This substudy will compare samples from different reservoirs to learn more about the following:

• Where HIV can be found
• Whether the amount of HIV is different in different reservoirs
• What is the best way is to measure the amount of HIV in different reservoirs
• Whether the amount of HIV found in any one reservoir can tell us anything about the amount of HIV in any of the other reservoirs

Who can join the substudy, A5341s?

A5321 participants are eligible to enroll in the A5341s substudy if they:

• Agree to participate in one or more of the following groups:
  • Group A: lumbar puncture – cerebrospinal fluid (CSF) collected
  • Group B: leukapheresis – blood collected using a special procedure
  • Group C: rectal biopsy – tissue collected from the rectum
  • Group D: genital secretions – semen from men, vaginal cells and fluid from women
• Have not had consecutive plasma HIV RNA values >200 copies/mL after 48 weeks on anti-HIV medicationsNOTE:    When the substudy A5341s first opens to enrollment, only people who are willing to be in Group A, Group B, or Group C (with or without being in one other group) may enroll. People who are only willing to be in Group D will not be able to enroll until later.

What do I need to do in the substudy, A5341s?

Participants enrolled in one or more groups will undergo the following procedures:

• Group A: lumbar puncture – CSF collected once as part of A5321 and 4 times in A5341s (at about 6 to 12 month intervals)
• Group B: leukapheresis –  large volume of blood collected 1 time
• Group C: rectal biopsy – collected 2 times (at least 12 months apart)
• Group D: genital secretions – collected 5 times (about every 6 months)

All participants will also have blood and hair samples collected and neuropsychological testing performed approximately every 6 months.

Participants will be expected to stay in the substudy A5341s for about 2 years while still remaining in the main study A5321. Some A5321 and A5341s visits can be combined.

ACTG A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

Study Description

AHRC (pronounced “ARC”) is a study of differences and changes over time in HIV reservoirs (groups of HIV-infected cells that “hide” from anti-HIV medications).   Blood will be collected twice a year for about 7 years from HIV-infected participants on anti-HIV therapy.

Study Status

Enrolling

Why is this study being done?

This study is being done to try to answer questions about the ways that HIV infection is controlled. This may have to do with a person’s viral load and CD4 count when they started their anti-HIV medications, how soon after their HIV infection they started anti-HIV medications, and/or genetic factors.

Who can join?

800×600 HIV-infected men and women at least 18 years of age, who:

• Participated in AIDS Clinical Trials Group (ACTG) study A5276s or A5001 and were not on anti-HIV medications at entry into the A5001 parent study (Group 1)
  OR
• Started anti-HIV medications very shortly after HIV infection (Group 2)
  OR
• Participated in ACTG study A5308 (Group 3)
• Are taking anti-HIV medications that have been controlling their viral load for 1-2 years
• Have never stopped anti-HIV medications for more than 3 weeks.
• Have no active hepatitis B or C infection, autoimmune disorder, or condition requiring steroid therapy.

What do I need to do in the study?

Participants will attend visits twice a year for about 7 years. At these visits, blood and a small amount of hair will be collected.

Participants who meet additional criteria will be asked to have one set of additional optional procedures at some point after they enter the study. The special procedures are a neurological assessment (some simple tests to measure your coordination and memory) and a lumbar puncture or spinal tap. The spinal tap will be done to collect some fluid from your spinal column; tests on this fluid can tell researchers about HIV in the brain. Anyone asked to participate in this part of the study will be given more information about it and will have an opportunity to ask questions before making a decision. You do not have to decide now.

What treatments or drugs are involved with this study?

Participants must be taking and planning to continue taking their current anti-HIV medications. These medications will not be supplied through this study.

Is there anything else I need to know about this study?

Separate but related fluid and tissue collections are planned as a substudy of A5321 known as A5341s (Longitudinal Sampling Substudy of A5321). Participants will undergo different types of procedures to help understand how and where HIV might remain even though the level of HIV in their blood has been very low while taking anti-HIV drugs. See above.