Pharmacokinetics of JULUCA in Hemodialysis

NCT04431518 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: ViiV Healthcare IIS 1837
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; ESRD

Keywords

HIV; ESRD; Hemodialysis; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Dolutegravir (DTG) Ctau

  Steady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14

  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

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

Secondary Outcomes (3)

• Safety of DTG

  30 days

• DTG AUC

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

• DTG Cmax

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

Study Arms (2)

Hemodialysis Group

EXPERIMENTAL

Receipt of JULUCA one pill per day up to 14 days

Drug: JULUCA 50Mg-25Mg Tablet

Normal Renal Function Group

ACTIVE COMPARATOR

Receipt of JULUCA one pill per day up to 14 days

Drug: JULUCA 50Mg-25Mg Tablet

Interventions

JULUCA 50Mg-25Mg Tablet DRUG

One dose of JULUCA will be taken daily for up to 14 days

Hemodialysis Group; Normal Renal Function Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• NOTE: The approximate date that hemodialysis was initiated should be reported, if known.
• For the normal renal function group: Estimated CrCl (using the Cockcroft-Gault equation) at screening ≥75mL/min.
• 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):
• AST (SGOT) and ALT (SGPT) less than or equal to ULN
• Total bilirubin less than or equal to 1.5 x ULN
• Hemoglobin greater than or equal to 8.0 mg/dL
• 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.

You may not qualify if:

• 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.
• Known liver cirrhosis, unstable liver disease (presence of ascites, encephalopathy, coagulopathy, esophageal/gastric varices), Child-Pugh Class A, B, or C, or known biliary abnormalities (except for known Gilbert's syndrome or asymptomatic gallstones).
• Hepatitis B surface antigen or hepatitis C antibody with detectable RNA at screening.
• Known gastrointestinal disease that may lead to poor absorption of the study drugs.
• Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
• Any of the following gastrointestinal signs or symptoms of Grade ≥ 2 within 7 days prior to the Screening Visit or during study drug administration prior to the Intensive PK Study Visit:
• nausea
• vomiting
• diarrhea
• abdominal pain
• Use of any of the following within 30 days of initiating study drug:
• Medications known to appreciably inhibit or induce CYP3A enzymes, P-glycoprotein, or UGT1A1 or UGT1A4 enzymes (e.g., anticonvulsants such as carbamazepine, phenytoin, oxacarbamazepine; antimycobacterials such as rifampin, rifabutin and rifapentine; antifungal agents such as ketoconazole, fluconazole and itraconazole; verapamil, clarithromycin, erythromycin)
• St. John's Wort, echinacea, grapefruits or grapefruit juice, garlic supplements, ginseng, golden seal, and milk thistle

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Samir Gupta

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Kidney Failure, Chronic

Interventions

dolutegravir, rilpivirine drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Samir K. Gupta
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

3172747926

Study Officials

• Samir K Gupta, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Matched case-control

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: April 23, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: June 5, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will become available after publication of the data, anticipated to be by July 2022.
• Access Criteria: Fully available when posted to online repositories. Additional data upon request and approval by the study investigators. The financial sponsor will not have a role in this process.

Locations

US (1)