What side effects are associated with this type of intervention?

Common treatments for HIV infection, such as Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), are generally well-tolerated but can have side effects. Patients on these regimens may experience gastrointestinal issues (nausea, diarrhea), headaches, and fatigue. Weight gain has been noted, particularly with tenofovir alafenamide-containing regimens. Some patients may also experience changes in bone density and renal function. Neuropsychiatric symptoms, such as insomnia and mood changes, have been reported, especially with regimens containing integrase inhibitors like bictegravir. Regular monitoring and consultation with healthcare providers are essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV, including those used in the regimens Symtuza and Biktarvy. Symtuza combines darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, while Biktarvy combines bictegravir, emtricitabine, and tenofovir alafenamide. These regimens include nucleoside reverse transcriptase inhibitors (NRTIs) like emtricitabine and tenofovir alafenamide, a protease inhibitor (darunavir), a pharmacokinetic enhancer (cobicistat), and an integrase strand transfer inhibitor (bictegravir). These components have been individually approved by the FDA for their efficacy in reducing HIV viral load and are now available in single-tablet formulations to improve patient adherence and treatment outcomes.

What other types of research exist?

Promising, novel alternatives to Symtuza and Biktarvy for HIV treatment in 2024 include newer integrase strand transfer inhibitors (INSTIs) like cabotegravir, which is used in combination with rilpivirine for long-acting injectable therapy. This regimen has shown efficacy in maintaining viral suppression with the convenience of less frequent dosing. Additionally, doravirine, a newer non-nucleoside reverse transcriptase inhibitor (NNRTI), combined with other agents, may offer a favorable side effect profile, including potentially less impact on weight gain and BMI changes.

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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial compares two HIV treatments to see which one causes more weight gain. It focuses on people with HIV who are experiencing weight gain from their medications. Researchers will study tiny molecules called micro-RNAs to understand why this weight gain happens. One type of treatment has been associated with more weight gain compared to other treatments.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Calorie intake of subjects in the two groups.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~650

Symtuza

2019

Completed Phase 3

~490

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV, such as Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), work by targeting different stages of the HIV life cycle. Darunavir is a protease inhibitor that prevents the virus from maturing and becoming infectious. Cobicistat boosts the effectiveness of darunavir by inhibiting liver enzymes that metabolize it. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) that block the reverse transcription process, preventing the virus from replicating its genetic material. Bictegravir, found in Biktarvy, is an integrase inhibitor that prevents the viral DNA from integrating into the host cell's genome. These mechanisms are vital for HIV patients as they reduce viral load, improve immune function, and prevent the progression to AIDS.

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.Bictegravir: First Global Approval.