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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
One dose of JULUCA will be taken daily for up to 14 days
Samir Gupta
Indianapolis, Indiana, United States
Dolutegravir (DTG) Ctau
Steady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Time frame: 0 to 24 hours post-dose on the intensive study visit
Rilpivirine (RPV) Ctau
Steady-state plasma Ctau for rilpivirine at the intensive study visit, which occurred between days 11 and 14
Time frame: 0 to 24 hours post-dose on the intensive study visit
Safety of DTG
The attributable grade 3 or 4 adverse events associated with use of DTG will be assessed during the study. Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Grade 3 indicates a severe event, and Grade 4 indicates a potentially life-threatening event.
Time frame: 30 days
DTG AUC
Steady-state plasma AUC for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Time frame: 0 to 24 hours post-dose on the intensive study visit
DTG Cmax
Steady-state plasma Cmax for dolutegravir at the intensive study visit, which occurred between days 11 and 14
Time frame: 0 to 24 hours post-dose on the intensive study visit
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