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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Experimental | Participants receive a BIC/F/TAF tablet orally once daily with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Number of CD4+ T lymphocyte counts will be obtained from lab reports | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine B Small, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29925489 | Background | 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. | |
| 28867497 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Participants receive a BIC/F/TAF tablet orally once daily with or without food. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Participants receive a BIC/F/TAF tablet orally once daily with or without food. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml | HIV viral loads will be obtained from lab reports. | One subject was excluded from data analysis due to early study withdrawal. | Posted | Count of Participants | Participants | Up to week 48 (End of Study) |
|
|
Up to week 48 (End of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Participants receive a BIC/F/TAF tablet orally once daily with or without food. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose Stool/ Diarrhea | Gastrointestinal disorders | Systematic Assessment |
The sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics can be presented for the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Small, MD | Weill Cornell Medicine | 212-746-9803 | cbs9003@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2023 | Jun 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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|
| 12 weeks, 24 weeks, 48 weeks (End of study) |
CD4+ T lymphocyte percentages will be obtained from lab reports |
| 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 | Data for kidney graft rejection will be extracted from biopsy confirmed rejections. | 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 | 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. | Week 24, Week 48 (End of study) |
| 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. |
| 28219610 | 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. |
| 28993180 | 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. |
| 26627107 | 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. |
| 30460547 | 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. |
| 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). |
| 21083386 | 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. |
| 25791727 | 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. |
| 25896688 | 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. |
| 28099191 | 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. |
| 30958667 | 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/ |
| 22935078 | 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. |
| 27572401 | 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. |
| 24055850 | 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. |
| 21118913 | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE) | One subject was excluded from data analysis due to early withdrawal. | Posted | Count of Participants | Participants | Up to week 48 (End of study) |
|
|
|
| Primary | 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. | One subject was excluded from data analysis due to early withdrawal. | Posted | Geometric Mean | 95% Confidence Interval | Femtomole (fmol)/punch of DBS | 12 weeks |
|
|
|
| Primary | 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 | One subject was excluded from data analysis due to early withdrawal. | Posted | Geometric Mean | 95% Confidence Interval | pmol/10^6 cells | 12 weeks |
|
|
|
| Primary | Renal Function as Measured by Blood Urea Nitrogen (BUN) | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Standard Deviation | mg/dL | 24 weeks, 48 weeks (End of study) |
|
|
|
| Primary | Renal Function as Measured by Creatinine | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Standard Deviation | mg/dL | 24 weeks, 48 weeks (End of study) |
|
|
|
| Primary | Renal Function as Measured by Creatinine Clearance | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Standard Deviation | mL/min | 24 weeks, 48 weeks (End of study) |
|
|
|
| Primary | Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 24 weeks, 48 weeks (End of study) |
|
|
|
| Primary | Tacrolimus Levels | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Standard Deviation | ng/mL | 12 weeks, 24 weeks, 48 weeks (End of study) |
|
|
|
| Secondary | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Number of CD4+ T lymphocyte counts will be obtained from lab reports | 1 participant was excluded from data analysis due to early withdrawal. | Posted | Mean | Full Range | cells/µL | Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study) |
|
|
|
| Secondary | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | CD4+ T lymphocyte percentages will be obtained from lab reports | 1 participant was excluded from data analysis due to early withdrawal. | Posted | Mean | Full Range | Percentage of CD4+ lymphocytes | Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study) |
|
|
|
| Secondary | Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant | Data for kidney graft rejection will be extracted from biopsy confirmed rejections. | 1 participant was excluded from data analysis due to early withdrawal. | Posted | Count of Participants | Participants | up to 48 weeks (End of study) |
|
|
|
| Secondary | 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. | One subject was excluded from data analysis due to early withdrawal. | Posted | Mean | Full Range | score on a scale | Week 24, Week 48 (End of study) |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 5 |
| 20 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Week 36 |
|
| Week 48 (End of Study) |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Week 36 |
|
| Week 48 (End of Study) |
|