Back to results

Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Primary Purpose

HIV Infections, Renal Transplant Rejection

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

BIKTARVY 50Mg-200Mg-25Mg Tablet

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Positive, Post Renal Transplant, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Antiretroviral, Biktarvy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biktarvy

Arm Description

Participants receive a Biktarvy tablet orally once daily with or without food.

Outcomes

Primary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA <50 copies/ml

HIV viral loads will be obtained from lab reports

Safety, as measured by number of participants with at least one adverse event

Adverse events will only include those that are determined to be related to the study drug

Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire

Tolerability will be measured by the health-related quality of life questionnaire to assess satisfaction with a one pill regimen. The health-related questionnaire ranges from 0 to 6 with higher scores indicating greater satisfaction.

Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function

Relationships will be determined by linear regression analysis.

Secondary Outcome Measures

Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant

CD4 lymphocyte counts and percentages will be obtained from lab reports

Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels

Data for kidney graft rejection rates will be extracted from biopsy confirmed rejections and observed along with levels of Tacrolimus obtained from blood samples.

Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire

Satisfaction will be measured by the self-reporting health-related quality of life questionnaire ranging from 0 to 6 with higher scores indicating greater satisfaction with Biktarvy.

Full Information

NCT ID

NCT04530630

First Posted

August 24, 2020

Last Updated

June 6, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04530630

Brief Title

Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Official Title

The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 9, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. 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 Biktarvy. The investigator hypothesizes that Biktarvy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Renal Transplant Rejection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biktarvy

Arm Type

Experimental

Arm Description

Participants receive a Biktarvy tablet orally once daily with or without food.

Intervention Type

Drug

Intervention Name(s)

BIKTARVY 50Mg-200Mg-25Mg Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of subjects with plasma HIV-1 RNA <50 copies/ml

Description

HIV viral loads will be obtained from lab reports

Time Frame

Week 48

Title

Safety, as measured by number of participants with at least one adverse event

Description

Adverse events will only include those that are determined to be related to the study drug

Time Frame

Approximately 1 month after final study visit

Title

Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire

Description

Time Frame

Week 4, Week 12, Week 24, Week 36, Week 48, 3 Month Follow Up, 6 Month Follow Up

Title

Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function

Description

Relationships will be determined by linear regression analysis.

Time Frame

Day 1, Day 3, Day 5, Day 8, Day 11, Day 22, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up

Secondary Outcome Measure Information:

Title

Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant

Description

CD4 lymphocyte counts and percentages will be obtained from lab reports

Time Frame

Day 1, Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up

Title

Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels

Description

Data for kidney graft rejection rates will be extracted from biopsy confirmed rejections and observed along with levels of Tacrolimus obtained from blood samples.

Time Frame

Approximately 3 months after primary outcome completion

Title

Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire

Description

Satisfaction will be measured by the self-reporting health-related quality of life questionnaire ranging from 0 to 6 with higher scores indicating greater satisfaction with Biktarvy.

Time Frame

Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Received a kidney from a donor who was HIV positive (unless a false positive) Currently taking Biktarvy for treatment of HIV Has allergies to any of the HIV medications in Biktarvy (bictegravir, emtricitabine, or tenofovir alafenamide) Currently taking dofetilide or rifampin Is pregnant or breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine B Small, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29925489

Citation

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. Erratum In: Lancet HIV. 2018 Jun 22;:

Results Reference

background

PubMed Identifier

28867497

Citation

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.

Results Reference

background

PubMed Identifier

28219610

Citation

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.

Results Reference

background

PubMed Identifier

28993180

Citation

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.

Results Reference

background

PubMed Identifier

26627107

Citation

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.

Results Reference

background

PubMed Identifier

30460547

Citation

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. Erratum In: Drugs. 2019 Mar 22;:

Results Reference

background

Citation

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).

Results Reference

background

PubMed Identifier

21083386

Citation

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. Erratum In: N Engl J Med. 2011 Mar 17;364(11):1082.

Results Reference

background

PubMed Identifier

25791727

Citation

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.

Results Reference

background

PubMed Identifier

25896688

Citation

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.

Results Reference

background

PubMed Identifier

28099191

Citation

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.

Results Reference

background

PubMed Identifier

30958667

Citation

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/

Results Reference

background

PubMed Identifier

22935078

Citation

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.

Results Reference

background

PubMed Identifier

27572401

Citation

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.

Results Reference

background

PubMed Identifier

24055850

Citation

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.

Results Reference

background

PubMed Identifier

21118913

Citation

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.

Results Reference

background

Learn more about this trial

Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

We'll reach out to this number within 24 hrs