CABENUVA for HIV (CAPRI Trial)

Phase 3

Waitlist Available

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1through month 2, month 5 through month 6, and month 10 through month 12 (for auc)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial evaluates the safety and effectiveness of a long-term HIV medication in people with kidney problems. Participation is voluntary.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of CABENUVA may include allergic reactions to the medication components, potential liver enzyme increases leading to liver issues, digestive disturbances, blood disorders like anemia or clotting problems, fatigue, and injection site reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1through month 2, month 5 through month 6, and month 10 through month 12 (for auc)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1through month 2, month 5 through month 6, and month 10 through month 12 (for auc)

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1through month 2, month 5 through month 6, and month 10 through month 12 (for auc) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cabotegravir area under the curve

Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment

Cabotegravir plasma concentration over time

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

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