المصدر: A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants

المصدر: Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

المصدر: A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP

المصدر: An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1

المؤلفون: National Institute of Allergy and Infectious Diseases (NIAID)

المصدر: A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW)

المصدر: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection

Other URLs: http://engagezone.msd.com/ds_documentation.php

المصدر: An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

المؤلفون: HIV Prevention Trials Network, National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID)

المصدر: A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs

المؤلفون: Landovitz, Raphael J, Tao, Li, Yang, Juan, de Boer, Melanie, Carter, Christoph, Das, Moupali, Baeten, Jared M, Liu, Albert, Hoover, Karen W, Celum, Connie, Grinsztejn, Beatriz, Morris, Sheldon, Wheeler, Darrell P, Mayer, Kenneth H, Golub, Sarit A, Bekker, Linda-Gail, Diabaté, Souleymane, Hoornenborg, Elske, Myers, Janet, Leech, Ashley A, McCormack, Sheena, Chan, Philip A, Sweat, Michael, Matthews, Lynn T, Grant, Robert, Beyrer, Chris, Brown, Joelle, Clark, Jesse, Colson, Paul, Eakle, Robyn, Farley, Jason, Flash, Charlene A, Gallardo, Jorge, Gottlieb, Geoffrey, Grangeiro, Alexandre, Heffron, Renee, Hosek, Sybil, Hull, Mark, Idoko, John, Inwani, Irene, Koenig, Helen, Kurth, Ann, Lee, Shui-shan, Mayer, Kenneth, Mboup, Souleymane, Meyer, Jaimie, Mills, Anthony, Mujugira, Andrew, Pala, Pietro, Phoenix, John, Piatt, Janice, Russell, Darren, Sanders, Eduard, Scott, Rachel, Sevelius, Jae, Shang, Hong, Siegel, Marc, Swaminathan, Shobha, Tamayo, Vivian, Tan, Darrell, Taylor, Allan, Vuylsteke, Bea

المصدر: Clinical Infectious Diseases. 79(5)

مصطلحات موضوعية: Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Health Disparities, Clinical Trials and Supportive Activities, Sexually Transmitted Infections, Clinical Research, HIV/AIDS, Prevention, Women's Health, Infection, Good Health and Well Being, Humans, HIV Infections, HIV-1, Male, Female, Incidence, Anti-HIV Agents, Pre-Exposure Prophylaxis, Adult, Drug Resistance, Viral, Medication Adherence, Prospective Studies, Middle Aged, Tenofovir, Emtricitabine, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Young Adult, pre-exposure prophylaxis, emtricitabine, tenofovir disoproxil fumarate, Global F/TDF PrEP Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences

وصف الملف: application/pdf

URL الوصول: https://escholarship.org/uc/item/9j09602b
https://escholarship.org/content/qt9j09602b/qt9j09602b.pdf

المؤلفون: Patel, Nimish¹ (AUTHOR) nipatel@health.ucsd.edu, Morris, Sheldon^2,3 (AUTHOR), Burke, Leah³ (AUTHOR), Chow, Karen³ (AUTHOR), Pacheco, Deedee³ (AUTHOR), Anderson, Peter⁴ (AUTHOR), Stancyzk, Frank⁵ (AUTHOR), Blumenthal, Jill^2,3 (AUTHOR)

المصدر: British Journal of Clinical Pharmacology. Oct2024, Vol. 90 Issue 10, p2360-2365. 6p.

مصطلحات موضوعية: *TRANSGENDER people, *EMTRICITABINE-tenofovir, *HORMONE therapy, *TENOFOVIR, *BLOOD sampling

المصدر: Phase IV, Randomized, Multicenter and Double Clinical Trial Blind Designed to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities: MIND Study

المصدر: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083

المصدر: Body Composition Sub-study of the D2EFT Trial

المؤلفون: Yale University, Fogarty International Center of the National Institute of Health

المساهمون: Corina Lelutiu-Weinberger, Associate Professor of Health Sciences Research (in Nursing)

المصدر: Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries with Low Access to Biomedical Prevention

المؤلفون: Institut National de la Santé Et de la Recherche Médicale, France

المصدر: Phase III Multicenter Randomized Trial Evaluating in Patients At the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/emtricitabine and Dolutegravir or Tenofovir/emtricitabine and Darunavir/cobicistat

المؤلفون: Gilead Sciences

المصدر: 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
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 Oct;5(10):e545. doi: 10.1016/S2352-3018(18)30147-4.
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.
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.
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.
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.
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 Apr;79(6):687. doi: 10.1007/s40265-019-01101-4.
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. Erratum In: N Engl J Med. 2011 Mar 17;364(11):1082.
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.
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.
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.
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/
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.
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.
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.
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.

المصدر: A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection
Cespedes M, Das M, Hojilla JC, Blumenthal J, Mounzer K, Ramgopal M, Hodge T, Torres TS, Peterson C, Shibase S, Elliott A, Demidont AC, Callaghan L, Watson CC, Carter C, Kintu A, Baeten JM, Ogbuagu O. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PLoS One. 2022 Jun 3;17(6):e0267780. doi: 10.1371/journal.pone.0267780. eCollection 2022.

المؤلفون: Yale University, PolyBio Research Foundation

المساهمون: David Putrino, Professor

المصدر: Investigating the Feasibility of Repurposing HIV Antivirals in Adults with Long Covid

المؤلفون: Gilead Sciences

المساهمون: Hansel Tookes, Assistant Professor

المصدر: Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

المصدر: An Open Label, Comparative, Randomized , Phase IV Pilot Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load