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Antiretroviral Combination Therapy

JULUCA 50Mg-25Mg Tablet for HIV/AIDS

Phase 4
Waitlist Available
Led By Samir K Gupta, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26-30 days
Awards & highlights

Study Summary

This trial will compare how well the drugs in JULUCA work in HIV-negative patients who require hemodialysis, compared to those with normal renal function.

Eligible Conditions
  • HIV/AIDS
  • Renal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26-30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26-30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DTG Ctau
RPV Ctau
Secondary outcome measures
DTG and RPV AUC
DTG and RPV Cmax
Safety of DTG and RPV

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hemodialysis GroupExperimental Treatment1 Intervention
Receipt of JULUCA one pill per day up to 14 days
Group II: Normal Renal Function GroupActive Control1 Intervention
Receipt of JULUCA one pill per day up to 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JULUCA 50Mg-25Mg Tablet
2021
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,369 Total Patients Enrolled
Samir K Gupta, MDPrincipal Investigator - Indiana University School of Medicine
Indiana University
2 Previous Clinical Trials
104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other documented studies that have explored the efficacy of JULUCA 50Mg-25Mg Tablet?

"Currently, 45 active trial are examining JULUCA 50Mg-25Mg Tablet's efficiency and safety with 16 studies in the third phase. Most of these investigations take place at medical centres located in Durban, KwaZulu-Natal but there is a total 871 clinical sites participating worldwide."

Answered by AI

Are individuals under the age of forty able to partake in this clinical experiment?

"The age criteria for participants of this trial is 18 to 65 years. Additionally, there are 125 sub-18 case studies and 420 over-65 investigations being conducted in parallel."

Answered by AI

For what afflictions is JULUCA 50Mg-25Mg Tablet recommended?

"JULUCA 50Mg-25Mg Tablet is a suitable treatment for individuals who are naive to HIV-1 therapy, and weigh at least 35 kg."

Answered by AI

What is the sample size of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this experiment is in the process of seeking participants. The initial post was made on April 23rd 2021 and recently refreshed on November 6th 2022. Presently, 20 people are needed at one medical center for participation."

Answered by AI

Has JULUCA 50Mg-25Mg Tablet been sanctioned by the FDA?

"Our internal assessment of JULUCA 50Mg-25Mg Tablet safety scored it a 3, as its Phase 4 status confirms that the medication has already been approved."

Answered by AI

What eligibility criteria are needed to join this research endeavor?

"This medical study is searching for 20 individuals between 18 and 65 years old who suffer from HIV. The most pertinent criteria are the following: Patients must have been on chronic hemodialysis at an established centre for at least 6 months, possess other available venous access points aside from those used for dialysis, be male or female aged 18-65; if known, approximate date of initiation of haemodialysis should also be reported."

Answered by AI

Are there any remaining slots available for enrolment in this research?

"Affirmative, the information on clinicaltrials.gov suggests that enrollment for this research project is ongoing. Initially posted on April 23rd 2021 and last amended November 6th 2022, 20 patients are required from a single site."

Answered by AI
~2 spots leftby Mar 2025