Pharmacokinetics of JULUCA in Hemodialysis

Status Completed

Clinical Trial 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.

Clinical Trial Description

The pharmacokinetics (PK) of dolutegravir (DTG) and rilpivirine (RPV), the components of JULUCA, in patients with end stage renal disease (ESRD) requiring hemodialysis (HD) have not previously been adequately studied. It is possible that the PK of these drugs are affected by renal failure which may then compromise effectiveness and safety. This trial will rigorously assess the plasma PK and protein-binding of these two drugs in 10 HIV-negative patients requiring hemodialysis with 10 matched persons with normal renal function. All participants will receive JULUCA for up to 14 days and then undergo a 24 hour intensive PK evaluation. ;

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
ESRD
HIV Infections
HIV/AIDS

Clinical Trial Details

NCT number	NCT04431518
Study type	Interventional
Source	Indiana University
Contact
Status	Completed
Phase	Phase 4
Start date	April 23, 2021
Completion date	July 31, 2023

View Details

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