Effects of Biktarvy on CFR in Stable HIV Patients

NCT03656783 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2018P001579
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in Global CFR

  Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of \<2.0, which is associated with increased cardiovascular risk.

  baseline and week 24

Secondary Outcomes (4)

• Change in Peak Stress Global MBF

  baseline and 24 weeks

• Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))

  Baseline and 24 weeks

• Change in Myocyte Injury and Strain (hs Troponin (in ng/L))

  Baseline and 24 weeks

• Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))

  Baseline and 24 weeks

Study Arms (1)

HIV patients on stable therapy

OTHER

HIV patients on stable therapy switching from Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Drug: Biktarvy

Interventions

Biktarvy DRUG

Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects

Also known as: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)

HIV patients on stable therapy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 45 years for men and ≥ 55 years for women;
• 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;
• HIV RNA \< 200 copies/mL at last clinical measurement, done within the past 12 months prior to screening, with no intervening HIV RNA \> 200;
• Screening HIV RNA \< 50 copies/mL, CBC, and chemistries that, in the judgment of the investigator, do not preclude the use of Biktarvy.

You may not qualify if:

• 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 (LVEF \<40%) or significant valvular heart disease;
• cirrhosis;
• end stage renal disease on dialysis;
• uncontrolled hypertension (defined as SBP \>200 or DBP \>110);
• pregnancy;
• Patients requiring medications contraindicated with the components of B/F/TAF;
• Patients on active treatment for severe asthma or severe COPD.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Tufts Medical Center: collaborator
• Boston Medical Center: collaborator

Study Sites (3)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Huck DM, Weber B, Parks S, Divakaran S, Brown JM, Bibbo CF, Barrett L, Hainer J, Bay C, Martell L, Kogelman L, Triant VA, Chu J, Lin NH, Melbourne K, Sax PE, Di Carli MF. Coronary Microcirculatory Dysfunction in People With HIV and Its Association With Antiretroviral Therapy. J Am Heart Assoc. 2023 Nov 21;12(22):e029541. doi: 10.1161/JAHA.123.029541. Epub 2023 Nov 10.

  PMID: 37947105 DERIVED

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; bictegravir; emtricitabine tenofovir alafenamide

Results Point of Contact

• Title: Marcelo Di Carli, MD
• Organization: Brigham and Women's Hospital

mdicarli@bwh.harvard.edu

6177326290

Study Officials

• Marcelo Di Carli, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 4, 2018
• Study Start: September 14, 2018
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)