Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Are you on HIV treatment with Triumeq?

If so, you may be eligible for a study assessing cardiac risk compared with Biktarvy, another single tablet treatment for HIV. All participants receive cardiac scans, medication, and lab tests free of charge.

Brigham and Women's Hospital HIV Medicines Nuclear Scans How to Prevent Heart Disease
4 visits over 7 months
Estimated Time Commitment
Any Sex/Gender, 45-95 years
May Be Eligible
Payment up to $500, Meals
May Be Offered
Office visit, Injection or IV, Personal health tracking, PET scan, Blood draw
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

We are doing this research study to find out if the drug called Biktarvy (Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)) can help improve the blood flow to the heart in people with HIV. We think this is because Biktarvy reduces the inflammation in the heart arteries.


Biktarvy is approved by the U.S. Food and Drug Administration (FDA) for treatment of HIV. BIKTARVY contains the medicines bictegravir, emtricitabine, and tenofovir alafenamide.


This research study will compare the blood flow to your heart before starting Biktarvy and after 24 weeks of taking the drug. Biktarvy comes in tablet form and you will take it by mouth once a day.


The gold standard for measuring blood flow to the heart with imaging is known as Positron Emission Tomography (PET). A PET scan is a test that uses a radioactive tracer (dye) called N13 Ammonia. PET scans allow doctors to see the blood flow to the muscle of the heart. It also lets us calculate the blood flow using a measure called Coronary Flow Reserve (CFR). CFR adds information to help doctors diagnose heart disease. The use of N13 for PET scans is FDA-approved and these scans are routinely performed at Brigham and Women’s Hospital.


Why it is important

It is important to develop and study drug therapies for HIV patients that would be less harmful to the heart.


What we hope to accomplish

We hope that the results from this study prove that Biktarvy is a more-heart healthy alternative to Triumeq. 

Principal Investigator

Marcelo Di Carli, MD

Brigham and Women's Hospital

Public Profile

Who can participate


  • Patients with stable HIV (HIV RNA < 200 copies/mL at last clinical measurement)

  • Have been on abacavir/lamivudine/dolutegravir STR regimens (Triumeq) for at least 1 year

  • Age ≥ 45 years for men and ≥ 55 years for women

  • At least one coronary risk factor (any questions please reach out to the study team)

Who cannot participate


  • Unstable HIV disease or other medical condition that, in the opinion of the investigator, would interfere with the conduct of the study

  • History of cardiomyopathy or significant valvular heart disease

  • Cirrhosis

  • End stage renal disease on dialysis

  • Uncontrolled high blood pressure

  • Pregnancy

  • Patients currently taking the medications dofetilide and/or rifampin

  • Patients on active treatment for severe asthma or severe COPD

What you may be asked to do

At your study visits, we may: 



  • Ask you questions about yourself

  • Ask about your medical and surgical history

  • Review your medication list

  • Give you a physical exam, including height, weight and “vital signs” (blood pressure and heart rate, and oxygen saturation)

  • Do a 12-lead electrocardiogram (ECG)

  • Draw blood from you for testing. The blood test will include a pregnancy test if you are a woman who is able to become pregnant.  

  • Complete a PET/CT scan.


Project activities may include:

  • Office visit
  • Injection or IV
  • Personal health tracking
  • PET scan
  • Blood draw

Estimated Time Commitment

4 visits over 7 months

What You May Get

Participants will receive up to $500 in compensation and a meal voucher (1 voucher per study visit). 


Patricipants will also receive 6 months worth of Biktarvy free-of-charge.

Location

Shapiro Cardiovascular Center
70 Francis Street Boston, MA 02115

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Travel

  • Parking reimbursed
  • Accessible by public transportation

Travel and Parking Details

Parking by valet at 75 Francis Street or in the garages at 45 and 80 Francis Street will be reimbursed.

Additional Information

ClinicalTrials.gov Identifier

NCT03656783


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
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