Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant

NCT04530630 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-01021384
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.

Conditions

HIV Infections; Renal Transplant Rejection

Keywords

HIV Positive; Post Renal Transplant; Bictegravir/Emtricitabine/Tenofovir Alafenamide; Antiretroviral; Biktarvy

Outcome Measures

Primary Outcomes (9)

• Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml

  HIV viral loads will be obtained from lab reports.

  Up to week 48 (End of Study)

• Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)

  Up to week 48 (End of study)

• Intracellular TAF Levels as Measured by Dried Blood Spot

  Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.

  12 weeks

• Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)

  pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells

  12 weeks

• Renal Function as Measured by Blood Urea Nitrogen (BUN)

  24 weeks, 48 weeks (End of study)

• Renal Function as Measured by Creatinine

  24 weeks, 48 weeks (End of study)

• Renal Function as Measured by Creatinine Clearance

  24 weeks, 48 weeks (End of study)

• Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)

  24 weeks, 48 weeks (End of study)

• Tacrolimus Levels

  12 weeks, 24 weeks, 48 weeks (End of study)

Secondary Outcomes (4)

• Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant

  Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)

• Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant

  Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)

• Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant

  up to 48 weeks (End of study)

• Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire

  Week 24, Week 48 (End of study)

Study Arms (1)

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)

EXPERIMENTAL

Participants receive a BIC/F/TAF tablet orally once daily with or without food.

Drug: BIC/F/TAF 50Mg-200Mg-25Mg Tablet

Interventions

BIC/F/TAF 50Mg-200Mg-25Mg Tablet DRUG

A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.

Also known as: Biktarvy

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)

Eligibility Criteria

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

You may qualify if:

• At least 18 years old on day of signing informed consent
• Positive for human immunodeficiency virus (HIV)
• Received a previous renal transplant
• Must have controlled HIV infection for at least 3 months prior to enrollment

You may not qualify if:

• Received a kidney from a donor who was HIV positive (unless a false positive)
• Currently taking BIC/F/TAF for treatment of HIV
• Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide)
• Currently taking dofetilide or rifampin
• Is pregnant or breastfeeding

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (16)

• Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, Lopez-Cortes L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e357-e365. doi: 10.1016/S2352-3018(18)30092-4. Epub 2018 Jun 18.

  PMID: 29925489 BACKGROUND

• Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. 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. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

  PMID: 28867497 BACKGROUND

• Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.

  PMID: 28219610 BACKGROUND

• Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.

  PMID: 28993180 BACKGROUND

• Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.

  PMID: 26627107 BACKGROUND

• Deeks ED. Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection. Drugs. 2018 Nov;78(17):1817-1828. doi: 10.1007/s40265-018-1010-7.

  PMID: 30460547 BACKGROUND

• Eron JJ, Lelievre J-D, Kalayjian R, Slim J, et al. Safety and Efficacy of E/C/F/TAF in HIV-Infected Adults on Chronic Hemodialysis (Abstract, poster 732 presented at CROI 2018).

  BACKGROUND

• Stock PG, Barin B, Murphy B, Hanto D, Diego JM, Light J, Davis C, Blumberg E, Simon D, Subramanian A, Millis JM, Lyon GM, Brayman K, Slakey D, Shapiro R, Melancon J, Jacobson JM, Stosor V, Olson JL, Stablein DM, Roland ME. Outcomes of kidney transplantation in HIV-infected recipients. N Engl J Med. 2010 Nov 18;363(21):2004-14. doi: 10.1056/NEJMoa1001197.

  PMID: 21083386 BACKGROUND

• Locke JE, Mehta S, Reed RD, MacLennan P, Massie A, Nellore A, Durand C, Segev DL. A National Study of Outcomes among HIV-Infected Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Sep;26(9):2222-9. doi: 10.1681/ASN.2014070726. Epub 2015 Mar 19.

  PMID: 25791727 BACKGROUND

• Gunawardana M, Remedios-Chan M, Miller CS, Fanter R, Yang F, Marzinke MA, Hendrix CW, Beliveau M, Moss JA, Smith TJ, Baum MM. Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis. Antimicrob Agents Chemother. 2015 Jul;59(7):3913-9. doi: 10.1128/AAC.00656-15. Epub 2015 Apr 20.

  PMID: 25896688 BACKGROUND

• Kraft JC, McConnachie LA, Koehn J, Kinman L, Collins C, Shen DD, Collier AC, Ho RJ. Long-acting combination anti-HIV drug suspension enhances and sustains higher drug levels in lymph node cells than in blood cells and plasma. AIDS. 2017 Mar 27;31(6):765-770. doi: 10.1097/QAD.0000000000001405.

  PMID: 28099191 BACKGROUND

• Pharmacoeconomic Review Report: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) (Biktarvy): (Gilead Sciences Canada, Inc.): Indication: A complete regimen for the treatment of HIV-1 infection in adults with no known substitution associated with resistance the individual components of Biktarvy [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK539546/

  PMID: 30958667 BACKGROUND

• Castillo-Mancilla JR, Zheng JH, Rower JE, Meditz A, Gardner EM, Predhomme J, Fernandez C, Langness J, Kiser JJ, Bushman LR, Anderson PL. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retroviruses. 2013 Feb;29(2):384-90. doi: 10.1089/AID.2012.0089. Epub 2012 Oct 10.

  PMID: 22935078 BACKGROUND

• Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.

  PMID: 27572401 BACKGROUND

• Zheng JH, Guida LA, Rower C, Castillo-Mancilla J, Meditz A, Klein B, Kerr BJ, Langness J, Bushman L, Kiser J, Anderson PL. Quantitation of tenofovir and emtricitabine in dried blood spots (DBS) with LC-MS/MS. J Pharm Biomed Anal. 2014 Jan;88:144-51. doi: 10.1016/j.jpba.2013.08.033. Epub 2013 Aug 31.

  PMID: 24055850 BACKGROUND

• Anderson PL, Kiser JJ, Gardner EM, Rower JE, Meditz A, Grant RM. Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. J Antimicrob Chemother. 2011 Feb;66(2):240-50. doi: 10.1093/jac/dkq447. Epub 2010 Nov 30.

  PMID: 21118913 BACKGROUND

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

The sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics can be presented for the study.

Results Point of Contact

• Title: Catherine Small, MD
• Organization: Weill Cornell Medicine

cbs9003@med.cornell.edu

212-746-9803

Study Officials

• Catherine B Small, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: November 9, 2020
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)