Healthy Adults Needed for Drug Levels Study

S
Samir Gupta, MD

Primary Investigator

Healthy Adults Needed for Drug Levels Study
Administratively Closed
18 years - 65 years
All
Phase N/A
10 participants needed
2 Locations

Brief description of 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. 
 

Detailed description of study

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.
 
 
Compensation
  • Total compensation for completion of all study requirements is $300 in the form of a prepaid gift card.

How to Participate

**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 diground@iu.edu 
 

 

Additional Information

Study Title:  The Steady-State Pharmacokinetics of Dolutegravir/Rilpivirine Fixed Dose Combination (FDC) in Patients with End Stage Renal Disease (ESRD) Requiring Hemodialysis

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: healthy volunteer
  • Age: 18 years - 65 years
  • Gender: All

Inclusion Criteria:
  • Overall good health
     
Exclusion Criteria:
  • Have HIV infection
  • Any disease or conditions related to kidneys, liver, or gut
  • Are receiving or have received dialysis
  • If female, must not be pregnant or breastfeeding

Updated on 07 Jan 2025. Study ID: INFD-IIR-PK-DTG-RPV-HD, 2008564139, TX11416

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team