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A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA | Clinical Trials | Clareo Health

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

An Open-label Study Evaluating the Pharmacokinetics (PK), Efficacy, Safety, and Tolerability of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) Intramuscular (IM) Administered Monthly and Every 2 Months in Virologically Suppressed HIV-1-Infected Adults With Severe Renal Impairment With or Without Hemodialysis (CAPRI)

NCT05601128•Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The purpose of this study is to evaluate CABENUVA (Long-acting Cabotegravir (CAB) Plus Long-acting Rilpivirine (RPV)) pharmacokinetics (movement of drugs within the body), safety and control of HIV in participants with renal (kidney) disease compared to historical values observed in those with normal renal function. Giving these drugs as an injection in your muscle (intramuscular) may offer be better tolerated by the body and may be simpler than taking a regular oral medication. Researchers want to find out if two drugs long-acting CABENUVA can help people with HIV and kidney disease when given every 8 weeks (2 months) or every 4 weeks (monthly). 12 patients will be enrolled into this study between two study sites. For the purposes of this project, we have applied for and received an FDA IND exemption (IND #161158) as this is a pilot study and not intended to result in a change in product labeling.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older, at the time of signing the informed consent.
•2. A female participant is eligible to participate if she is not pregnant as confirmed by negative urine HCG test at screening and at each study visits), not lactating, and at least one of the following conditions applies:
•Non-reproductive potential defined as:
•Pre-menopausal females with one of the following:
•1. Documented tubal ligation
•2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
•3. Hysterectomy
•4. Documented Bilateral Oophorectomy
•Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood test result of simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
•Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (see Appendix 6) from 30 days prior to the first dose of study medication, throughout the study, for at least 14 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
+5 more criteria

Exclusion Criteria

•1. Screening plasma HIV-1 RNA measurement \> 50 c/mL
•2. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \> 200 c/mL
•3. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
•4. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
•5. Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
•6. Participants who, in the investigator's judgment, pose a significant suicide risk as assessed via the Columbia Suicidality Severity Rating Scale (C-SSRS). In addition, participant's recent history of mental health, psychiatric history, suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
•7. Evidence of active Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
•* Participants positive for HBsAg are excluded:
•* Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded, not excluded if HBV DNA is negative or not detected
•* Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded
+26 more criteria

Locations (1)

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

January 1, 2023

Primary Completion Date

April 1, 2025

Completion Date

May 1, 2025

Last Updated

June 4, 2025

Enrollment

ACTUAL participants

Conditions

HIV-1-infectionHIV InfectionsHIV I Infection

Interventions

CAB + RPV

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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