Clinical Trials

Tenofovir alafenamide fumarate has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on HIV-1, chronic hepatitis B, pediatric efficacy, oral regimen safety, metabolic effects, drug adherence, mother-to-child transmission prevention, and SARS-CoV-2. Supported by academic institutions, government organizations such as the National Institute of Allergy and Infectious Diseases, and industry sponsors like Gilead Sciences, these studies encompass various recruitment statuses, including completed, active, recruiting, not recruiting, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03753074 ACTIVE_NOT_RECRUITING
Chronic Hepatitis b
Young-Suk Lim
 2019-02-18 PHASE4
NCT07708727 RECRUITING
HIV-1-infection
Gilead Sciences
 2026-07-29 PHASE2; PHASE3
NCT07792096 NOT_YET_RECRUITING
HIV Infection
University College, London
 2026-11 PHASE3
NCT06707922 ENROLLING_BY_INVITATION
Chronic Hepatitis B
Xiamen Amoytop Biotech Co., Ltd.
 2022-03-18
NCT07266831 RECRUITING
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Merck Sharp & Dohme LLC
 2025-12-18 PHASE2; PHASE3
NCT07258251 NOT_YET_RECRUITING
Chronic Hepatitis B; Hepatitis B Virus Infection
The Task Force for Global Health
 2026-01-01 PHASE4
NCT07797231 NOT_YET_RECRUITING
Chronic Hepatitis B
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2026-09 PHASE3
NCT06947356 RECRUITING
Hepatitis B
Guangzhou 8th People's Hospital
 2025-05-03
NCT07055451 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2025-08-12 PHASE1
NCT05652478 RECRUITING
Healthy Volunteer; Weight Gain; Metabolic Effects; Integrase Strand Transfer Inhibitors
National Institute of Allergy and Infectious Diseases (NIAID)
 2026-09-09 PHASE2
NCT06544733 ACTIVE_NOT_RECRUITING
HIV-1-Infection
Gilead Sciences
 2024-08-20 PHASE2; PHASE3
NCT07095855 NOT_YET_RECRUITING
Chronic Hepatitis B
Shanghai Zhimeng Biopharma, Inc.
 2025-08 PHASE3
NCT03933384 RECRUITING
Hepatitis B; Viral Hepatitis
Taichung Veterans General Hospital
 2019-08-19 PHASE4
NCT05195450 RECRUITING
Non-cirrhotic, Chronic Hepatitis B
Institute of Liver and Biliary Sciences, India
 2022-02-23
NCT06891066 ACTIVE_NOT_RECRUITING
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Merck Sharp & Dohme LLC
 2025-04-14 PHASE2
NCT07645287 RECRUITING
HIV-1-infection
Gilead Sciences
 2026-06-15 PHASE2
NCT07476339 RECRUITING
HIV -1 Infection; HIV (Human Immunodeficiency Virus); HIV; HIV 1 Infection
CAN Community Health
 2026-06-17 PHASE4
NCT07202546 RECRUITING
HIV Infections
ViiV Healthcare
 2026-02-11 PHASE2
NCT07349758 RECRUITING
Healthy Volunteer; HIV Prevention
Johns Hopkins University
 2026-01-06 PHASE1
NCT06221657 NOT_YET_RECRUITING
Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
Yonsei University
 2024-02-01 PHASE4
NCT07031063 RECRUITING
HIV Infection; Metabolic Syndrome; Antiretroviral Treatment
Instituto Mexicano del Seguro Social
 2025-04-01 PHASE4
NCT02932150 ACTIVE_NOT_RECRUITING
Chronic Hepatitis B
Gilead Sciences
 2016-11 PHASE2
NCT07210528 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment (MCI); Alzheimer Dementia (AD)
National University Hospital, Singapore
 2025-06-30 PHASE1
NCT06374758 ACTIVE_NOT_RECRUITING
HIV Infections; ART; Noncompliance, Patient
University of Missouri-Columbia
 2024-04-29 PHASE4
NCT07532304 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2026-05-11 PHASE1
NCT07678268 RECRUITING
HIV Infection; Antiretroviral Therapy; Lentivirus Infections
Instituto Mexicano del Seguro Social
 2025-07-10 PHASE4
NCT07075146 RECRUITING
HIV - Human Immunodeficiency Virus; Obesity; Overweight and/or Obesity
José Antonio Mata Marín
 2025-05-05 PHASE3
NCT07295873 COMPLETED
Chronic Hepatitis B Liver Fibrosis; DDI (Drug-Drug Interaction)
Beijing Continent Pharmaceutical Co, Ltd.
 2026-03-15 PHASE1
NCT06630286 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2024-10-09 PHASE3
NCT05979311 ACTIVE_NOT_RECRUITING
HIV; HIV Infections
ViiV Healthcare
 2024-02-21 PHASE3
NCT06589518 NOT_YET_RECRUITING
Hepatitis B Virus; Liver Transplant; Renal Insufficiency
Jongman Kim
 2025-03-01 PHASE2
NCT06613685 TERMINATED
HIV-1-infection
Gilead Sciences
 2024-10-21 PHASE2; PHASE3
NCT05911360 COMPLETED
HIV; HIV Infections
ViiV Healthcare
 2023-07-07 PHASE3
NCT04674423 UNKNOWN
Chronic Hepatitis b
National Cheng-Kung University Hospital
 2020-05-14 PHASE4
NCT05853718 RECRUITING
Chronic Hepatitis b; Tenofovir Alafenamide Fumarate
First People's Hospital of Hangzhou
 2021-05-06 PHASE4
NCT06150014 ACTIVE_NOT_RECRUITING
Chronic Hepatitis b
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2023-12-07 PHASE1; PHASE2
NCT06333808 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2024-03-25 PHASE3
NCT04820933 COMPLETED
HIV I Infection; Cardiovascular Risk Factor; Lipid Metabolism Disorders
University of Texas Southwestern Medical Center
 2024-03-01 EARLY_PHASE1
NCT05550519 WITHDRAWN
Hepatitis B, Chronic
Janssen Pharmaceutica N.V., Belgium
 2022-10-31 EARLY_PHASE1
NCT05898841 COMPLETED
HIV Infections; Fatty Liver Disease
Fundacion SEIMC-GESIDA
 2023-05-26 PHASE4
NCT05001672 UNKNOWN
HBV; Inflammatory Arthritis
Taipei Veterans General Hospital, Taiwan
 2021-08-15 PHASE4
NCT05993767 COMPLETED
HIV Infection
PENTA Foundation
 2024-12-11 PHASE2
NCT02016924 ACTIVE_NOT_RECRUITING
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2014-01-16 PHASE2; PHASE3
NCT05326971 UNKNOWN
HIV Infections; Weight Gain
Jussi Sutinen
 2023-01-19 PHASE4
NCT06274398 COMPLETED
Safety Issues
Eastern Virginia Medical School
 2024-01-16 PHASE1
NCT02881320 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Gilead Sciences
 2016-09-21 PHASE2; PHASE3
NCT06221605 COMPLETED
Chronic Hepatitis B
Wecare Probiotics Co., Ltd.
 2024-03-30
NCT05463783 UNKNOWN
HIV Infections; Obesity
East Carolina University
 2023-03-14 PHASE4
NCT05467553 UNKNOWN
Hepatitis D
National Taiwan University Hospital
 2023-02-24 PHASE2
NCT06000657 COMPLETED
Hepatitis B, Chronic
Daewoong Pharmaceutical Co. LTD.
 2023-08-28 PHASE4
NCT04564547 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2021-03-09 PHASE2
NCT04496882 ACTIVE_NOT_RECRUITING
Chronic Hepatitis b; Hepatitis B Reactivation
National Taiwan University Hospital
 2020-09-09 PHASE4
NCT03920618 RECRUITING
Hepatitis B; Acute-On-Chronic Liver Failure
Third Affiliated Hospital, Sun Yat-Sen University
 2019-02-21
NCT04619082 ACTIVE_NOT_RECRUITING
Hepatitis B Reactivation
Chiayi Christian Hospital
 2021-07-01 PHASE4
NCT05721300 UNKNOWN
Hepatocellular Carcinoma; Chronic Hepatitis B
Zhongshan Hospital (Xiamen), Fudan University
 2023-02-10
NCT06087913 COMPLETED
Safety Issues
Eastern Virginia Medical School
 2023-11-08 PHASE1
NCT05663892 ACTIVE_NOT_RECRUITING
Hiv; Transgenderism
Maple Leaf Research
 2022-11-23 PHASE4
NCT03356834 COMPLETED
Chronic Hepatitis B
Humanity and Health Research Centre
 2017-12-01 PHASE4
NCT05630755 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2023-02-17 PHASE3
NCT04636437 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2021-07-27 PHASE4
NCT04530630 COMPLETED
HIV Infections; Renal Transplant Rejection
Weill Medical College of Cornell University
 2020-11-09 PHASE4
NCT06592300 COMPLETED
Chronic Hepatitis B in Adults and Paediatric Patients
Humanis Saglık Anonim Sirketi
 2024-07-06 PHASE1
NCT05404919 WITHDRAWN
Lung Transplant; Hepatitis B
University of Pennsylvania
 2022-09-06 PHASE2
NCT05490836 UNKNOWN
Chronic Hepatitis B
Huashan Hospital
 2022-09
NCT05244057 COMPLETED
Chronic Hepatitis B
Shanghai HEP Pharmaceutical Co., Ltd.
 2022-08-23 PHASE2
NCT04231565 RECRUITING
Hepatitis B Virus
Third Affiliated Hospital, Sun Yat-Sen University
 2020-06-04
NCT06356194 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2024-04-15 PHASE1
NCT05410496 ACTIVE_NOT_RECRUITING
Safety Issues; Chronic Hepatitis B; Transplant Recipient
Taichung Veterans General Hospital
 2021-06-22 PHASE4
NCT04994509 ACTIVE_NOT_RECRUITING
Pre-Exposure Prophylaxis of HIV Infection
Gilead Sciences
 2021-08-30 PHASE3
NCT03804372 TERMINATED
Large-B-cell Diffuse Lymphoma; Chronic Lymphoid Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
 2020-07-07 PHASE2
NCT06278389 COMPLETED
Healthy Adult Participants
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
 2024-01-24 PHASE1
NCT04939441 UNKNOWN
Chronic Hepatitis B
Jidong Jia
 2021-04-20 PHASE4
NCT05652478 Not yet recruiting
Healthy Volunteer|Weight Gain|Metabolic Effects|Integrase Strand Transfer Inhibitors
National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health Clinical Center (CC)
 2024-05-15 Phase 2
NCT04388904 COMPLETED
HIV-1-infection
The Crofoot Research Center, Inc.
 2021-09-01 PHASE4
NCT03916328 UNKNOWN
Bone Loss
MU-JHU CARE
 2019-12-03 PHASE4
NCT05602506 COMPLETED
HIV Infections
Fundacion Clinic per a la Recerca Biomédica
 2022-11-15 PHASE4
NCT05122754 UNKNOWN
HIV-1-infection
Shanghai Public Health Clinical Center
 2021-12-08 PHASE4
NCT04880577 WITHDRAWN
Multiple Sclerosis, Relapsing-Remitting; Fatigue
Massachusetts General Hospital
 2022-09-15 PHASE2
NCT04616963 ACTIVE_NOT_RECRUITING
Hiv; Hormone Therapy
University of California, San Diego
 2019-10-24 PHASE4
NCT04891770 COMPLETED
Chronic Hepatitis B
Gilead Sciences
 2021-08-14 PHASE2
NCT04734652 COMPLETED
HIV/AIDS; Tuberculosis, Pulmonary
Centre for the AIDS Programme of Research in South Africa
 2022-02-18 PHASE2
NCT04195074 UNKNOWN
Chronic Hepatitis b
Third Affiliated Hospital, Sun Yat-Sen University
 2019-01-01
NCT05177926 UNKNOWN
Hepatitis B, Chronic; Mother to Child Transmission
Nanfang Hospital, Southern Medical University
 2021-04-04 PHASE4
NCT04290936 UNKNOWN
HCC Patients After Curative Treatment With Low HBV Viral Load
Taipei Veterans General Hospital, Taiwan
 2020-10-16 PHASE4
NCT05405751 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2022-07-04 PHASE4
NCT05458765 COMPLETED
Acceptability of Health Care; Adherence, Medication
Eastern Virginia Medical School
 2022-06-21 PHASE2
NCT05275023 COMPLETED
Hepatitis B, Chronic
Janssen Research & Development, LLC
 2022-06-30 PHASE2
NCT06104306 Recruiting
HIV-1-infection
Gilead Sciences
 2023-12-13 Phase 4
NCT04997564 UNKNOWN
Chronic Hepatitis C; Chronic Hepatitis B
Peking University First Hospital
 2021-08 PHASE4
NCT04196998 UNKNOWN
Hepatitis B; Compensated Cirrhosis
Third Affiliated Hospital, Sun Yat-Sen University
 2019-01-01
NCT05583006 Recruiting
Patient Satisfaction|Drug Adherence|Efficacy Self|Safety Issues
Taichung Veterans General Hospital|Institute of Adherence to Medication
 2023-11-06 --
NCT06177574 COMPLETED
HIV Infections
Carmen Hidalgo Tenorio
 2020-10-27 PHASE4
NCT04535544 COMPLETED
Hepatitis D, Chronic
Janssen Research & Development, LLC
 2020-09-17 PHASE2
NCT04593680 ACTIVE_NOT_RECRUITING
Drug Interaction
Thai Red Cross AIDS Research Centre
 2022-01-24
NCT04201808 UNKNOWN
Hepatitis B, Chronic
New Discovery LLC
 2021-05-01 PHASE4
NCT06773754 ACTIVE_NOT_RECRUITING
Virally Suppressed People With HIV
National Taiwan University Hospital
 2022-06-14
NCT04439539 COMPLETED
Hepatitis B, Chronic
Janssen Research & Development, LLC
 2020-09-14 PHASE2
NCT04442737 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2020-07-01 PHASE4
NCT04585737 COMPLETED
HIV I Infection
Charlotte-Paige Rolle, MD
 2020-10-05 PHASE4
NCT04249037 TERMINATED
HIV/AIDS
University of Colorado, Denver
 2020-12-15 PHASE4
NCT04937881 COMPLETED
Hiv
University of California, Los Angeles
 2022-06-13 PHASE3
NCT05243602 COMPLETED
HIV-1-infection
University of Nairobi
 2022-02-01 PHASE4
NCT03727152 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
 2019-05-01 PHASE3
NCT05489406 COMPLETED
Hiv
Radboud University Medical Center
 2022-10-06 PHASE1
NCT05423106 TERMINATED
Healthy; Hepatitis B, Chronic
Janssen Research & Development, LLC
 2022-07-04 PHASE1
NCT04585789 COMPLETED
Hepatitis B
Janssen Research & Development, LLC
 2021-03-11 PHASE2
NCT04850950 UNKNOWN
Chronic Hepatitis B; Mother-to-Child Transmission; Safety; Efficacy; Hepatitis B Virus; Tenofovir Alafenamide Fumarate
The First Affiliated Hospital of Zhengzhou University
 2021-04-26 PHASE4
NCT04712058 UNKNOWN
HIV Infections
National Taiwan University Hospital
 2021-01-20
NCT03887702 TERMINATED
Hepatitis B Infection; Malignant Solid Neoplasm
SWOG Cancer Research Network
 2020-01-17 PHASE3
NCT03797014 COMPLETED
HIV-1-infection; Hepatitis B
University of Maryland, Baltimore
 2019-04-30 PHASE4
NCT02437110 COMPLETED
Amyotrophic Lateral Sclerosis
National Institute of Neurological Disorders and Stroke (NINDS)
 2019-04-01 PHASE1
NCT03510468 COMPLETED
Healthy Volunteers
National Institutes of Health Clinical Center (CC)
 2018-06-12 PHASE1
NCT04483674 UNKNOWN
HIV Primary Infection
Anna Cruceta
 2020-12-04 PHASE2
NCT04629976 COMPLETED
Chronic Hepatitis B
Nucorion Pharmaceuticals, Inc.
 2021-01-12 PHASE1
NCT04070079 UNKNOWN
Hepatitis B, Chronic
University Health Network, Toronto
 2019-01-29 PHASE4
NCT04391608 UNKNOWN
Renal Insufficiency; Tenofovir
Mahidol University
 2019-11-09 PHASE4
NCT05063071 UNKNOWN
HBV; POST LIVER TRANSPLANT
Fudan University
 2021-07-29 PHASE4
NCT04542070 COMPLETED
HIV Infections
ViiV Healthcare
 2020-11-09 PHASE3
NCT04040075 TERMINATED
HIV-1-infection
Southampton Healthcare, Inc.
 2019-07-01 PHASE4
NCT04311957 UNKNOWN
HIV-1-infection; Antiretroviral Therapy
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
 2020-09-01 PHASE4
NCT05453448 COMPLETED
Antiviral Drugs
Xiangya Hospital of Central South University
 2022-05-01
NCT04667104 COMPLETED
Hepatitis B, Chronic
Janssen Research & Development, LLC
 2021-02-01 PHASE2
NCT03122262 COMPLETED
HIV-1 Infection
Professor Francois Venter
 2017-01-16 PHASE3
NCT03471624 COMPLETED
Hepatitis B, Chronic
Stanford University
 2018-05-01 PHASE4
NCT04703465 UNKNOWN
HBV; Liver Transplant Disorder
RenJi Hospital
 2021-04-01
NCT03547908 COMPLETED
HIV-1/HBV Co-Infection
Gilead Sciences
 2018-05-30 PHASE3
NCT04295460 UNKNOWN
HIV Infection
Hospitales Universitarios Virgen del Rocío
 2020-03-10 PHASE4
NCT04222283 UNKNOWN
HIV Infections
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2020-08-17 PHASE4
NCT04538040 COMPLETED
HIV-1-infection
Quest Clinical Research
 2019-12-19 PHASE4
NCT03717129 COMPLETED
Healthy Volunteers
Johns Hopkins University
 2019-04-15 PHASE4
NCT04501224 UNKNOWN
Chronic Hepatitis b; Cirrhosis Due to Hepatitis B
Third Affiliated Hospital, Sun Yat-Sen University
 2020-08-03
NCT03998176 COMPLETED
HIV-1-infection
University of Nebraska
 2019-10-09 PHASE4
NCT04551573 WITHDRAWN
Tuberculosis; Hiv
Yale University
 2021-05 PHASE4
NCT04302896 COMPLETED
Medication Adherence; HIV
Rhonda Brand
 2020-08-31 EARLY_PHASE1
NCT03656783 COMPLETED
HIV
Brigham and Women's Hospital
 2018-09-14 PHASE3
NCT04223791 COMPLETED
HIV Infection
Merck Sharp & Dohme LLC
 2020-02-18 PHASE3
NCT04129554 COMPLETED
Hepatitis B, Chronic
Janssen Sciences Ireland UC
 2019-11-06 PHASE2
NCT04661397 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-01-05 PHASE1
NCT03549689 WITHDRAWN
HIV/AIDS; HIV-1-infection; Osteopenia
Philip Grant
 2019-08-01 PHASE2
NCT03251144 COMPLETED
HIV/AIDS; Antiviral Toxicity; Antiviral Drug Adverse Reaction; Mitochondrial Alteration
University of California, Los Angeles
 2019-04-01 PHASE1; PHASE2
NCT04853524 WITHDRAWN
Healthy
Janssen Research & Development, LLC
 2021-05-06 PHASE1
NCT04034368 UNKNOWN
HBV
The First Hospital of Jilin University
 2019-08 PHASE4
NCT03858478 UNKNOWN
HIV Seropositivity
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2019-11-18 PHASE4
NCT03986697 WITHDRAWN
Coronary Artery Disease; Hiv
University of Liverpool
 2020-02-04 PHASE4
NCT03241641 COMPLETED
Chronic Hepatitis b
Young-Suk Lim
 2017-10-26 PHASE4
NCT03905655 COMPLETED
Chronic Hepatitis B
Romark Laboratories L.C.
 2019-10-22 PHASE2
NCT04047420 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-12-11 PHASE1
NCT02815566 COMPLETED
Osteoporosis; HIV; Menopause
University Health Network, Toronto
 2017-09-12 PHASE4
NCT04683341 UNKNOWN
HBV
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2020-09-01 PHASE4
NCT03695029 UNKNOWN
Hepatitis B Virus Infection
National Taiwan University Hospital
 2010-12-29 PHASE4
NCT04507607 UNKNOWN
Chronic Hepatitis B; Mother-to-child Block; Antiviral Treatment
Third Affiliated Hospital, Sun Yat-Sen University
 2020-08-01 EARLY_PHASE1
NCT03348163 TERMINATED
HIV Infections
The University of Texas Health Science Center, Houston
 2018-06-06 PHASE4
NCT02859558 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2017-01-24 PHASE2
NCT04405271 TERMINATED
Healthcare Workers; COVID-19; SARS-CoV 2
Hospital Italiano de Buenos Aires
 2020-07-31 PHASE3
NCT04424264 COMPLETED
HIV-1-infection; Tuberculosis
Professor Francois Venter
 2019-12-05 PHASE1
NCT03048422 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-01-19 PHASE3
NCT03512964 COMPLETED
Human Immunodeficiency Virus
Johns Hopkins University
 2016-11-29
NCT03798119 UNKNOWN
Hepatitis B; Fibrosis and Cirrhosis of Liver
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2019-02-25 PHASE4
NCT03489239 ACTIVE_NOT_RECRUITING
Hepatitis B
Thomas Jefferson University
 2017-11-16 PHASE3
NCT03532425 TERMINATED
HIV-1-infection
University of Alberta
 2018-10-29 PHASE4
NCT04155554 UNKNOWN
HIV-1-infection
Azienda Ospedaliera Universitaria Senese
 2020-01-29 PHASE3
NCT03604016 UNKNOWN
Hepatitis B
IlDong Pharmaceutical Co Ltd
 2018-09-23 PHASE4
NCT03549312 UNKNOWN
HIV-1-infection; Hepatitis C, Chronic; Methadone Dependence; Opioid Dependence; Bone Diseases, Metabolic; HIV/AIDS; Co-infection; Buprenorphine Dependence; HCV Coinfection
Saskatchewan Health Authority - Regina Area
 2018-02-01 PHASE4
NCT04132674 UNKNOWN
Human Immunodeficiency Virus I Infection; Drug Use
Vancouver Infectious Diseases Centre
 2018-11-26 PHASE4
NCT03685500 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2018-12-04 PHASE4
NCT02957864 UNKNOWN
Renal Insufficiency,Chronic; Hiv; Therapeutic Agent Toxicity
Erasmus Medical Center
 2016-10 PHASE4
NCT03693508 COMPLETED
HIV Infections; Severe Immunosuppression
Fundacion SEIMC-GESIDA
 2018-04-13 PHASE4
NCT01854775 COMPLETED
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2013-05-06 PHASE2; PHASE3
NCT03405194 WITHDRAWN
HIV/AIDS
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
 2018-05-01
NCT04236453 TERMINATED
Healthy
Janssen Pharmaceutica N.V., Belgium
 2020-01-23 PHASE1
NCT04059198 TERMINATED
Hepatitis B; HBV; Hepatitis B, Chronic
F-star Therapeutics, Inc.
 2019-10-10 PHASE2
NCT03499483 COMPLETED
HIV Prevention
Fenway Community Health
 2019-01-24 PHASE4
NCT04006704 COMPLETED
HIV-1
Janssen Pharmaceutica N.V., Belgium
 2019-10-10 PHASE1
NCT04054089 COMPLETED
HIV Infections
Cristina Mussini
 2020-01-23 PHASE4
NCT03434353 TERMINATED
Chronic Hepatitis B
Gilead Sciences
 2018-02-28 PHASE2
NCT03502005 COMPLETED
Human Immunodeficiency Virus
Midland Research Group, Inc.
 2018-03-01 PHASE4
NCT03115736 COMPLETED
HIV and Hepatitis B Coinfection
Insel Gruppe AG, University Hospital Bern
 2017-05-23 PHASE2
NCT02285114 COMPLETED
HIV-1
Gilead Sciences
 2015-01-20 PHASE2; PHASE3
NCT03631732 COMPLETED
HIV-1 Infection
Gilead Sciences
 2018-08-28 PHASE3
NCT03126370 COMPLETED
Hepatitis C; HIV Coinfection
University of Colorado, Denver
 2018-01-08 PHASE4
NCT02962739 COMPLETED
Healthy Volunteers
University of Colorado, Denver
 2016-03 PHASE1
NCT03067285 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2017-09-08 PHASE4
NCT03836729 COMPLETED
HIV Infections
ViiV Healthcare
 2019-02-11 PHASE1
NCT03180619 COMPLETED
Chronic Hepatitis B
Gilead Sciences
 2017-06-29 PHASE2
NCT03762772 COMPLETED
Hiv; HSV
CONRAD
 2018-12-10 PHASE1
NCT02842086 ACTIVE_NOT_RECRUITING
Pre-Exposure Prophylaxis of HIV-1 Infection
Gilead Sciences
 2016-09-02 PHASE3
NCT03227861 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2017-07-31 PHASE3
NCT03110380 COMPLETED
HIV-1-infection
Gilead Sciences
 2017-06-12 PHASE3
NCT03405935 COMPLETED
HIV-1 Infection
Gilead Sciences
 2018-03-01 PHASE3
NCT02616029 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-12-17 PHASE3
NCT02979613 COMPLETED
Chronic Hepatitis B
Gilead Sciences
 2016-12-29 PHASE3
NCT02771054 COMPLETED
HIV
Göteborg University
 2016-05-02 PHASE4
NCT02998320 COMPLETED
HIV Risk
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
 2017-03-10 PHASE3
NCT03350672 COMPLETED
Hiv
Philadelphia Fight
 2017-11-16 PHASE4
NCT03493568 TERMINATED
HIV-1-infection
IRCCS San Raffaele
 2017-02-06 PHASE3
NCT02616783 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-12-22 PHASE3
NCT02862548 COMPLETED
Chronic Hepatitis B
Gilead Sciences
 2016-09-16 PHASE2
NCT03186482 COMPLETED
HIV
St. Stephens Clinical Research
 2017-06-01 PHASE1
NCT02660905 COMPLETED
Human Immunodeficiency Virus; Hepatitis C, Chronic
Ottawa Hospital Research Institute
 2016-04 PHASE3
NCT02904369 COMPLETED
HIV
CONRAD
 2016-10-06 PHASE1
NCT02652624 COMPLETED
HIV-1 Infection
Gilead Sciences
 2016-02-19 PHASE3
NCT02707601 COMPLETED
HIV-1 Infection; HCV Infection
Gilead Sciences
 2016-04-01 PHASE3
NCT03092206 COMPLETED
Insulin Resistance
Technical University of Munich
 2017-04-18 PHASE1
NCT02957994 UNKNOWN
Hepatitis B
Asian Pacific Liver Center at Coalition of Inclusive Medicine
 2016-12-22 PHASE4
NCT02605954 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-18 PHASE3
NCT02603107 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-20 PHASE3
NCT02607956 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-11 PHASE3
NCT02607930 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-13 PHASE3
NCT02836236 COMPLETED
HBV; Chronic HBV Infection
Gilead Sciences
 2015-06-19 PHASE3
NCT02836249 COMPLETED
HBV; Chronic HBV Infection
Gilead Sciences
 2015-06-19 PHASE3
NCT02431247 COMPLETED
Immunodeficiency Virus Type 1, Human
Janssen Sciences Ireland UC
 2015-07-06 PHASE3
NCT02984852 COMPLETED
Healthy
Janssen Scientific Affairs, LLC
 2016-12 PHASE1
NCT02269917 COMPLETED
Human Immunodeficiency Virus Type 1
Janssen R&D Ireland
 2015-03 PHASE3
NCT02556333 TERMINATED
HIV
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-09-16 PHASE2
NCT02345226 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-01-26 PHASE3
NCT02345252 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-01-26 PHASE3
NCT02578550 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-11 PHASE1
NCT02397694 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-03-23 PHASE2
NCT01940471 COMPLETED
HBeAg-positive Chronic Hepatitis B
Gilead Sciences
 2013-09-11 PHASE3
NCT01940341 COMPLETED
HBeAg-negative Chronic Hepatitis B
Gilead Sciences
 2013-09-12 PHASE3
NCT02475135 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-06-01 PHASE1
NCT01968551 COMPLETED
HIV-1; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
 2013-09-03 PHASE3
NCT01967940 COMPLETED
HIV; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
 2013-10-25 PHASE3
NCT02296853 COMPLETED
Hepatitis B Virus
Gilead Sciences
 2014-12-22 PHASE1
NCT02071082 COMPLETED
HIV; HBV
Gilead Sciences
 2014-02-25 PHASE3
NCT01797445 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2013-03-12 PHASE3
NCT01780506 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2012-12-26 PHASE3
NCT01818596 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2013-03-27 PHASE3
NCT01497899 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-12-28 PHASE2
NCT00036634 COMPLETED
HIV Infections
Gilead Sciences
 2002-03 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2024-12-17)

Check the Tenofovir alafenamide fumarate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a prodrug converted intracellularly to tenofovir diphosphate, tenofovir alafenamide fumarate competitively inhibits viral reverse transcriptase and incorporates into nascent viral DNA, terminating chain elongation and halting viral replication. This targeted intracellular inhibition suppresses viral load, providing the pharmacological basis for its clinical evaluation in treating HIV-1 infection and chronic hepatitis B.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.