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HIV InfectionsPhase 4NCT04530630

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

A Phase 4 study testing BIC/F/TAF 50Mg-200Mg-25Mg Tablet in people with HIV Infections and Renal Transplant Rejection, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Renal Transplant Rejection
What is being tested?
BIC/F/TAF 50Mg-200Mg-25Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
9 Nov 2020to 28 Aug 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Being tested
BIC/F/TAF 50Mg-200Mg-25Mg Tablet
Keywords
HIV Positive, Post Renal Transplant, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Antiretroviral, Biktarvy
Medical subject headings
HIV Infections, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIC/F/TAF 50Mg-200Mg-25Mg TabletDrug

    Also called Biktarvy

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

Study groups in NCT04530630
Study groupRoleWhat they receive
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)ExperimentalParticipants receive a BIC/F/TAF tablet orally once daily with or without food.
Receives: Drug: BIC/F/TAF 50Mg-200Mg-25Mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    HIV viral loads will be obtained from lab reports.

    Measured: Up to week 48 (End of Study)

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

    Measured: Up to week 48 (End of study)

  3. 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.

    Measured: 12 weeks

  4. 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

    Measured: 12 weeks

  5. Renal Function as Measured by Blood Urea Nitrogen (BUN)

    Measured: 24 weeks, 48 weeks (End of study)

  6. Renal Function as Measured by Creatinine

    Measured: 24 weeks, 48 weeks (End of study)

  7. Renal Function as Measured by Creatinine Clearance

    Measured: 24 weeks, 48 weeks (End of study)

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

    Measured: 24 weeks, 48 weeks (End of study)

  9. Tacrolimus Levels

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

Secondary outcomes (4)

  1. Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant

    Number of CD4+ T lymphocyte counts will be obtained from lab reports

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

  2. Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant

    CD4+ T lymphocyte percentages will be obtained from lab reports

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

  3. Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant

    Data for kidney graft rejection will be extracted from biopsy confirmed rejections.

    Measured: up to 48 weeks (End of study)

  4. Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) 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.

    Measured: Week 24, Week 48 (End of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start9 Nov 2020
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530630
Sponsor's protocol ID
20-01021384
Status last verified
Jul 2025
First submitted
24 Aug 2020
Last updated
12 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29925489

  • 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.

    PubMed 28867497

  • 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.

    PubMed 28219610

  • 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.

    PubMed 28993180

  • 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.

    PubMed 26627107

  • 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.

    PubMed 30460547

  • 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).

  • 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.

    PubMed 21083386

  • 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.

    PubMed 25791727

  • 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.

    PubMed 25896688

  • 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.

    PubMed 28099191

  • 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/

    PubMed 30958667

  • 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.

    PubMed 22935078

  • 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.

    PubMed 27572401

  • 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.

    PubMed 24055850

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BIC/F/TAF 50Mg-200Mg-25Mg Tablet in people with HIV Infections and Renal Transplant Rejection, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml (time frame: Up to week 48 (End of Study)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530630, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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