CompletedPhase 4

Pharmacokinetics of JULUCA in Hemodialysis

United States8 participantsStarted 2021-04-23

Plain-language summary

This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.

Who can participate

Age range

18 Years – 65 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

. Negative HIV antibody testing at screening.
. For the ESRD requiring HD study group: ESRD requiring chronic hemodialysis for at least 6 months at an established center (not home dialysis).
. Availability of alternative venous access (not used for dialysis) for the purpose of PK sampling.
. The following laboratory values obtained within 30 days prior to study entry (obtained either at screening or done as part of routine clinical care):
. A negative serum pregnancy test result at screening for all women of reproductive potential who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
. Males and females, age 18-65 years.
. Ability and willingness of participant or legal guardian/representative to provide written informed consent.

Exclusion criteria

. Known allergy or hypersensitivity to either dolutegravir or rilpivirine
. Use of peritoneal dialysis.
. Serious illnesses, other than ESRD, requiring systemic treatment and/or hospitalization within 30 days prior to the Screening Visit.

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

Dolutegravir (DTG) Ctau

Timeframe: 0 to 24 hours post-dose on the intensive study visit

Rilpivirine (RPV) Ctau

Timeframe: 0 to 24 hours post-dose on the intensive study visit

Trial details

NCT IDNCT04431518

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

Results submitted2024-03-29

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