A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA (NCT05601128) | Clinical Trial Compass
CompletedPhase 3
A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA
United States12 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years or older, at the time of signing the informed consent.
. 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:
. Documented tubal ligation
. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
. Hysterectomy
. Documented Bilateral Oophorectomy
. Must be on uninterrupted current regimen (either the initial or second ARV regimen) for at least 6 months prior to Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cabotegravir plasma concentration over time
Timeframe: Month 2 through Month 12 (for Ctrough)
2
Cabotegravir plasma concentration over time
Timeframe: Month 2 through Month 12 (for Cmax)
3
Cabotegravir area under the curve
Timeframe: Month 1through Month 2, Month 5 through Month 6, and Month 10 through Month 12 (for AUC)
4
Rilpivirine plasma concentration over time
Timeframe: Month 2 through Month 12 (for Ctrough)
5
Rilpivirine plasma concentration over time
Timeframe: Month 2 through Month 12 (for Cmax)
6
Rilpivirine area under the curve
Timeframe: Month 1through Month 2, Month 5 through Month 6, and Month 10 through Month 12 (for AUC)
7
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Trial details
NCT IDNCT05601128
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
. Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: one within the 6 to 12-month window, and one within 6 months prior to Screening
. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \> 200 c/mL
. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
. 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
. 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.
. 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:
. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment within 12 months must be excluded.
Timeframe: Month 2 through Month 12
8
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Timeframe: Month 2 through Month 12
9
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Timeframe: Month 2 through Month 12
10
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Timeframe: Month 2 through Month 12
11
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Timeframe: Month 2 through Month 12
12
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment