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Antiretroviral Therapy

Biktarvy vs. Symtuza for HIV-Related Weight Gain

Phase 4
Recruiting
Led By Paul Cook, MD
Research Sponsored by East Carolina 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 48 weeks
Awards & highlights

Study Summary

This trial is testing whether two different HIV medications cause different amounts of weight gain, and whether this is related to micro-RNAs.

Who is the study for?
This trial is for adults over 18 with HIV and a viral load of at least 1000 copies/ml who haven't started treatment yet. They need internet access via smartphone and must be willing to consent. Excluded are those on weight-altering drugs, bedbound individuals, prisoners, pregnant women, people with extreme obesity or cachexia, or active substance abusers.Check my eligibility
What is being tested?
The study compares the effects of two HIV medications—Biktarvy and Symtuza—on microRNAs in the body and their potential link to weight gain over 48 weeks. It also looks at calorie intake's role in medication-related weight changes.See study design
What are the potential side effects?
Potential side effects from Biktarvy or Symtuza may include but are not limited to: digestive issues, headaches, fatigue, skin reactions, sleep disturbances. Specific side effects related to weight changes will be closely monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Calorie intake of subjects in the two groups.

Trial Design

2Treatment groups
Experimental Treatment
Group I: SymtuzaExperimental Treatment1 Intervention
15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.
Group II: BiktarvyExperimental Treatment1 Intervention
15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biktarvy
2018
Completed Phase 4
~210
Symtuza
2020
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,488 Total Patients Enrolled
East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,779 Total Patients Enrolled
Paul Cook, MDPrincipal InvestigatorEast Carolina University

Media Library

Biktarvy (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05463783 — Phase 4
Human Immunodeficiency Virus Infection Research Study Groups: Symtuza, Biktarvy
Human Immunodeficiency Virus Infection Clinical Trial 2023: Biktarvy Highlights & Side Effects. Trial Name: NCT05463783 — Phase 4
Biktarvy (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463783 — Phase 4

Frequently Asked Questions

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

Are there any open opportunities to apply for this investigation?

"This medical trial is no longer recruiting candidates, as evidenced by the clinicaltrials.gov listing which was published on July 1st 2022 and last modified two weeks later. However, there are currently 1438 other trials actively searching for patients."

Answered by AI

Is Biktarvy a risk-free drug for users?

"The safety of Biktarvy has been approved in a Phase 4 trial, and thus receives an elevated score of 3."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
What site did they apply to?
Adult Specialty Care Clinic-East Carolina University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Adult Specialty Care Clinic-East Carolina University: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
Paul Cook 2023. "Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05463783.
All > Weight Gain > Truvada
~13 spots leftby Mar 2025
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