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Antiretroviral Therapy

CABENUVA for HIV (CAPRI Trial)

Q: Is geriatric participation being sought in this investigation?

This clinical trial has a specified age range of 18-89. For those outside this age bracket, there are 300 studies for patients under 18 and 947 trials available to individuals over 65.

Q: Has the FDA authorized HIV + severe renal impairment medication?

Our company, Power, has assigned a score of 3 to <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> + severe renal impairment based on the data from this Phase 3 trial. This rating indicates that there is evidence for both efficacy and safety.

Q: Is this analysis currently recruiting participants?

Indeed, clinicaltrials.gov states that this trial is actively enrolling subjects. It was initially advertised on January 1st 2023 and has since been modified as of February 15th 2023.

Q: What is the aggregate number of participants involved in this investigation?

Indeed, the information on clinicaltrials.gov illustrates that this trial is presently seeking out participants. It was first advertised on January 1st 2023 and last modified on February 15th 2023. Currently, the study requires 12 patients to be sourced from a single location.

Q: Could I qualify as a subject in this research project?

This clinical trial requires 12 participants, aged 18-89 and living with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>. Furthermore, these patients must have had two separate plasma HIV-1 RNA measurements &#x3C;50 c/mL in the last year before screening; they must also be postmenopausal or use a highly effective contraceptive method while on the study intervention. Lastly, investigators need to ensure that subjects understand how to properly utilize their chosen contraceptives throughout this research process.

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

CAPRI 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.Check my eligibility

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.See study design

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.

CAPRI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

CAPRI 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

47 Previous Clinical Trials

13,067 Total Patients Enrolled

Media Library

CAB + RPV (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05601128 — Phase 3

HIV Research Study Groups: HIV + severe renal impairment

HIV Clinical Trial 2023: CAB + RPV Highlights & Side Effects. Trial Name: NCT05601128 — Phase 3

CAB + RPV (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601128 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation being sought in this investigation?

"This clinical trial has a specified age range of 18-89. For those outside this age bracket, there are 300 studies for patients under 18 and 947 trials available to individuals over 65."

Answered by AI

Has the FDA authorized HIV + severe renal impairment medication?

"Our company, Power, has assigned a score of 3 to HIV + severe renal impairment based on the data from this Phase 3 trial. This rating indicates that there is evidence for both efficacy and safety."

Answered by AI

Is this analysis currently recruiting participants?

"Indeed, clinicaltrials.gov states that this trial is actively enrolling subjects. It was initially advertised on January 1st 2023 and has since been modified as of February 15th 2023."

Answered by AI

What is the aggregate number of participants involved in this investigation?

"Indeed, the information on clinicaltrials.gov illustrates that this trial is presently seeking out participants. It was first advertised on January 1st 2023 and last modified on February 15th 2023. Currently, the study requires 12 patients to be sourced from a single location."

Answered by AI

Could I qualify as a subject in this research project?

"This clinical trial requires 12 participants, aged 18-89 and living with HIV. Furthermore, these patients must have had two separate plasma HIV-1 RNA measurements <50 c/mL in the last year before screening; they must also be postmenopausal or use a highly effective contraceptive method while on the study intervention. Lastly, investigators need to ensure that subjects understand how to properly utilize their chosen contraceptives throughout this research process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA

Chiu-Bin Hsiao, MD 2023. "A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05601128.