CompletedPhase 4

Pharmacokinetics of JULUCA in Hemodialysis

United States8 participantsStarted 2021-04-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. 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):
✓. 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.

Exclusion criteria

✕. 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:

What they're measuring

Dolutegravir (DTG) Ctau

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

Rilpivirine (RPV) Ctau

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

Trial details

NCT IDNCT04431518

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

Results submitted2024-03-29

View on ClinicalTrials.gov More HIV/AIDS trials