CABENUVA for HIV

(CAPRI Trial)

Overseen By Paige E Rutter

Age: 18+

Sex: Any

Trial Phase: Phase 3

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

Must be taking: Antiretrovirals

Must not be taking: Immunomodulators, Torsade de Pointes

Disqualifiers: Hepatitis B, Severe hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 months

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that decrease CABENUVA concentrations at least four weeks before starting the study. Other prohibited medications should be stopped at least two weeks before starting. If you are on any prohibited medications and cannot switch to an alternative, you may not be eligible to participate.

What data supports the effectiveness of the drug CABENUVA for HIV?

Research shows that CABENUVA, a combination of cabotegravir and rilpivirine, is effective as a long-acting injectable treatment for HIV-1. It is approved for people who have already achieved viral suppression with oral antiretroviral therapy, offering a convenient once-a-month dosing option. ^{1 2 3 4 5}

Is CABENUVA safe for humans?

CABENUVA, a combination of cabotegravir and rilpivirine, has been shown to have a favorable safety profile in clinical trials for people living with HIV. It is generally well-tolerated, with positive feedback from patients regarding the convenience and tolerability of the injections. ^{1 2 3 6 7}

What makes the drug CABENUVA unique for treating HIV?

CABENUVA is unique because it is the first complete long-acting injectable treatment for HIV, requiring only once-a-month intramuscular injections, which can be more convenient than daily oral medications. ^{1 2 3 4 8}

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 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CABENUVA monthly for 6 months followed by every 2 months for 6 months

12 months

Monthly visits for the first 6 months, then every 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CAB + RPV

Trial Overview 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.

Participant Groups

Group I: HIV + severe renal impairment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

52

Recruited

13,000+

Findings from Research

Cabotegravir (CAB) combined with rilpivirine (RPV) is the first long-acting dual therapy approved for HIV-1 treatment, showing comparable maintenance of viral suppression over 160 weeks with low rates of virological failure.

This regimen offers a convenient alternative to daily oral therapy, as it is administered via intramuscular injections every 4 weeks, with minimal adverse effects and no negative impact on renal or bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. Durham, SH., Chahine, EB.[2022]

Cabenuva is the first complete injectable therapy for adults with HIV-1, combining cabotegravir and rilpivirine, and is administered once a month after an initial month of oral treatment.

This innovative treatment offers a new option for HIV management, potentially improving adherence and convenience for patients compared to daily oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Extended-Release Injectable Drug Therapy for HIV. Aschenbrenner, DS.[2023]

Cabenuva (cabotegravir/rilpivirine) is a long-acting injectable treatment for HIV that has shown equal effectiveness to traditional oral antiretroviral therapy in maintaining HIV-1 suppression, based on major clinical trials like ATLAS and FLAIR.

The ATLAS-2 M study demonstrated that administering Cabenuva every 8 weeks is just as effective as every 4 weeks, which can improve patient adherence and reduce the stigma associated with frequent treatment, while also minimizing risks of treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV. Taki, E., Soleimani, F., Asadi, A., et al.[2022]

Cabotegravir/rilpivirine (CAB/RPV) is the first complete injectable antiretroviral therapy approved for HIV treatment, offering a monthly intramuscular injection option that improves adherence compared to daily oral medications.

Clinical trials have shown CAB/RPV to achieve high rates of sustained viral suppression with a favorable safety profile, while also enhancing patient satisfaction due to its convenience and confidentiality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. Howe, ZW., Norman, S., Lueken, AF., et al.[2022]

Long-acting injectable therapies, cabotegravir (CAB) and rilpivirine (RPV), have been shown to be as effective as traditional oral antiretroviral therapy (ART) for HIV-1, maintaining efficacy over 96 weeks in clinical trials with virologically suppressed adults.

CAB has also demonstrated effectiveness as a preexposure prophylaxis (PrEP) option, significantly reducing HIV infections compared to daily oral medication, indicating its potential for broader use in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. Bares, SH., Scarsi, KK.[2023]

CABENUVA™, a combination of extended-release injectable cabotegravir and rilpivirine, has been approved in Canada for treating HIV-1 in adults who are already virologically stable and suppressed.

The approval is based on positive results from the ATLAS and FLAIR trials, indicating that this regimen can effectively replace current antiretroviral therapies for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir Plus Rilpivirine: First Approval. Markham, A.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Frequency of genotypic factors possibly associated with cabotegravir/rilpivirine failure in antiretroviral treatment-naïve and -experienced HIV-1- infected population. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

First Extended-Release Injectable Drug Therapy for HIV. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Cabotegravir Plus Rilpivirine: First Approval. [2021]