NCT04431518

Pharmacokinetics of JULUCA in Hemodialysis

The Steady-State Pharmacokinetics (PK) of Dolutegravir/Rilpivirine Fixed Dose Combination (FDC) in Patients With End Stage Renal Disease (ESRD) Requiring Hemodialysis (HD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• HIV/AIDS
• ESRD

Interventions

Type	Name	Description
DRUG	JULUCA 50Mg-25Mg Tablet	One dose of JULUCA will be taken daily for up to 14 days

Timeline

• Start date: 2021-04-23
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2020-06-16
• Last updated: 2024-06-05
• Results posted: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study