Biktarvy for Obesity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Adult Specialty Care Clinic-East Carolina University, Greenville, NC
Obesity+1 More
Biktarvy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))[D/C/F/TAF] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))[B/F/TAF] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain.

Eligible Conditions

  • Obesity
  • HIV Infections

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Obesity

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 48 weeks

48 weeks
Calorie intake of subjects in the two groups.
Change from baseline in Body mass index-BMI(kg/m^2) of the participants
Change from baseline in body weight(in kilograms or kg) of the participants
miRNA(microRNA) profiles of the two groups

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Obesity

Trial Design

2 Treatment Groups

Biktarvy
1 of 2
Symtuza
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Biktarvy · No Placebo Group · Phase 4

Biktarvy
Drug
Experimental Group · 1 Intervention: Biktarvy · Intervention Types: Drug
Symtuza
Drug
Experimental Group · 1 Intervention: Symtuza · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biktarvy
2019
Completed Phase 4
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks
Closest Location: Adult Specialty Care Clinic-East Carolina University · Greenville, NC
Photo of Greenville 1Photo of Greenville 2Photo of Greenville 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Obesity
0 CompletedClinical Trials

Who is running the clinical trial?

East Carolina UniversityLead Sponsor
94 Previous Clinical Trials
33,153 Total Patients Enrolled
11 Trials studying Obesity
1,526 Patients Enrolled for Obesity
Janssen Scientific Affairs, LLCIndustry Sponsor
139 Previous Clinical Trials
566,631 Total Patients Enrolled
3 Trials studying Obesity
56 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.