CAB LA + RPV LA for HIV Infection (CROWN Trial)

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Eligibility Criteria

This trial is for individuals with HIV who are currently on oral antiretroviral therapy (ART) but still have detectable levels of the virus. Specific eligibility details are not provided, so it's best to contact the study organizers for more information.

Inclusion Criteria

I am currently on oral ART and willing to keep taking it.

I am 12 years or older and weigh at least 35 kg.

Exclusion Criteria

I have been diagnosed with HIV-1 Subtype A6.

I have a liver condition, such as cirrhosis or a bile duct problem.

I have HIV and Hepatitis B but am not on treatment for both.

I have used CAB, need long-term blood thinners, or take medications linked to heart rhythm issues.

My tests show drug resistance or specific abnormal lab values.

I have severe liver problems and am being treated for hepatitis C.

I am a minor under the care of the state or government.

Treatment Details

The effectiveness and durability of a long-acting injectable ART regimen using Cabotegravir (CAB LA) and Rilpivirine (RPV LA) is being tested in participants whose HIV remains detectable despite current treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: CAB LA + RPV LA GroupExperimental Treatment1 Intervention

Participants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months.

Group II: Oral ART Control GroupActive Control1 Intervention

Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.