Effects of Biktarvy on CFR in Stable HIV Patients

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Boston Medical Center; Tufts Medical Center
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

Patients with HIV on abacavir/lamivudine/dolutegravir STR regimens for at least 1 year fulfilling the following inclusion criteria:

1. age ≥ 45 years for men and ≥ 55 years for women;

2. at least one coronary risk factor including smoking, dyslipidemia, hypertension, obesity (BMI >30) or diabetes, or a calculated 10-year risk of heart attack of 7.5% or higher;

3. HIV RNA < 200 copies/mL at last clinical measurement, done within the past 12 months prior to screening, with no intervening HIV RNA > 200;

4. Screening HIV RNA < 50 copies/mL, CBC, and chemistries that, in the judgment of the investigator, do not preclude the use of Biktarvy.

Exclusion Criteria:

1. patients not fulfilling inclusion criteria;

2. unstable HIV disease or other medical condition that, in the opinion of the investigator, would interfere with the conduct of the study;

3. history of cardiomyopathy (LVEF <40%) or significant valvular heart disease;

4. cirrhosis;

5. end stage renal disease on dialysis;

6. uncontrolled hypertension (defined as SBP >200 or DBP >110);

7. pregnancy;

8. Patients requiring medications contraindicated with the components of B/F/TAF;

9. Patients on active treatment for severe asthma or severe COPD.