Healthy Adults Needed for Drug Levels Study
Researchers at the Indiana University School of Medicine are looking for healthy adults to take part in a study to help us understand the short-term safety and acceptability of JULUCA. This study will compare JULUCA blood levels in persons with normal kidney functioning to patients needing dialysis.
DID YOU KNOW?... JULUCA is an HIV combination pill already approved by the FDA for treating HIV. It is not known if this pill is the right dose for use in people with HIV needing dialysis. Because there is a growing number of people with HIV and with low kidney function needing dialysis, studies are needed to see how persons without any serious illness process JULUCA.
Who is Eligible
Adults between 18-65 years of age who:
- Do not have HIV infection
- Do not have any disease or conditions related to kidneys, liver, or gut
- Are not receiving or have not received dialysis
- If female, must not be pregnant or breastfeeding
What is Involved
You will be asked to attend 3 study visits at the Indiana Clinical Research Center at University Hospital in Indianapolis, IN and take the study medication (JULUCA) for up to two weeks.
Study visits will include:
- Brief exam and measurements of your height, weight, heart rate, heart rhythm, blood pressure, and temperature
- Surveys and questionnaires about your health and medical history
- One overnight study visit
- Collection of blood samples via an IV
- Phone calls
About 14 days after the overnight stay visit, we will call you to see if you have developed any side effects and to review your medication list one more time.
- Total compensation for completion of all study requirements is $300 in the form of a prepaid gift card.
**IF YOU ARE INTERESTED IN PARTICIPATING IN THIS STUDY, please follow these steps:
2.) Complete the prescreener questions below to see if you may qualify
**You may also reach out to the study team directly by contacting Danielle Grounds at firstname.lastname@example.org
Study Title: The Steady-State Pharmacokinetics of Dolutegravir/Rilpivirine Fixed Dose Combination (FDC) in Patients with End Stage Renal Disease (ESRD) Requiring Hemodialysis
- IRB Number: 2008564139
- Research Study Identifier: TX11416
- Principal Investigator: Samir Gupta, MD