CABENUVA for HIV
(CAPRI Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment. This study is considered research and is voluntary.

Eligibility Criteria

Adults with HIV and severe renal impairment can join this trial if they've been on a stable HIV treatment for at least 6 months, have undetectable viral loads, and use effective contraception. Pregnant or breastfeeding women, those planning to become pregnant, individuals with unstable kidney disease or severe liver issues are excluded.

Inclusion Criteria

I am on standard HIV-1 treatment and meet all required criteria.

I am 18 years old or older.

I am not pregnant, not breastfeeding, and meet the fertility criteria.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to during the study.

My condition did not improve with initial treatments.

Participants with evidence of active Hepatitis B virus (HBV) infection

+5 more

Participant Groups

The study is testing the effectiveness and safety of CABENUVA (Cabotegravir plus Rilpivirine) in patients with HIV who also have serious kidney problems. It's research to see how well these long-acting drugs work and how tolerable they are for participants.

1Treatment groups

Experimental Treatment

Group I: HIV + severe renal impairmentExperimental Treatment1 Intervention

CAB LA + RPV LA administered to HIV virologically suppressed participants with CKD stage 4/5 (CrCl \< 30 mL/min) with (n = 6) or without (n = 6) hemodialysis receiving CABENUVA monthly for 6 months followed by every 2 months for 6 months.