PK of JULUCA in Hemodialysis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- ESRD
- HIV/AIDS
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Matched case-controlMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The pharmacokinetics of dolutegravir and rilpivirine, the components of JULUCA, in patients with end stage renal disease requiring hemodialysis 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...
The pharmacokinetics of dolutegravir and rilpivirine, the components of JULUCA, in patients with end stage renal disease requiring hemodialysis 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.
Tracking Information
- NCT #
- NCT04431518
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Samir K Gupta, MD Indiana University School of Medicine
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