Tenofovir disoproxil

Generic Name: Tenofovir disoproxil

Brand Names: Atripla, Cimduo, Complera, Delstrigo, Stribild, Symfi, Truvada, Viread, Tenofovir disoproxil Mylan

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₃₀N_₅O_₁₀P

CAS Number: 201341-05-1

Unique Ingredient Identifier: F4YU4LON7I

Background: Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 .

Indication: Tenofovir disoproxil is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients ≥2 years old and weighing ≥10 kg. It is also indicated for the treatment of chronic hepatitis B in patients ≥2 years old and weighing ≥10 kg.

Tenofovir disoproxil is also an ingredient in several combination products, all of which are indicated either alone or in combination with other antiretrovirals for the treatment of HIV-1 infection.

In addition, tenofovir disoproxil is available in combination with emtricitabine (under the brand name Truvada) for use as pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing ≥ 35kg to reduce the risk of sexually-acquired HIV-1 infection.

Associated Conditions: Chronic Hepatitis B Infection, Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Phase 3

Recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept (W12-W48)
Drug: TNF Inhibitor (W12-W48)
Drug: TNF Inhibitor (W0-W12)

First Posted Date: 2022-06-23

Last Posted Date: 2025-03-06

Lead Sponsor: University Hospital, Montpellier

Target Recruit Count: 220

Registration Number: NCT05428488

Locations: 🇫🇷
APHP Bicêtre, Paris, France
🇫🇷
CHU Bordeaux groupe Pellegrin, Bordeaux, France
🇫🇷
CHU de Brest La Cavale Blanche, Brest, France

and more 14 locations

Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

Phase 4

Completed

Conditions: Chronic Hepatitis B Infection

Interventions: Other: Historical Data
Drug: Tenofovir disoproxil fumarate

First Posted Date: 2022-05-02

Last Posted Date: 2022-05-02

Lead Sponsor: Mylan (Taiwan) Ltd

Target Recruit Count: 40

Registration Number: NCT05355467

Locations: 🇨🇳
Taichung Veterans General Hospital, Taichung, Taiwan

An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

Phase 2

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: JNJ-73763989
Drug: PD-1 inhibitor
Drug: Tenofovir Disoproxil
Drug: Tenofovir Alafenamide
Drug: Entecavir

First Posted Date: 2022-03-11

Last Posted Date: 2025-04-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 37

Registration Number: NCT05275023

Locations: 🇪🇸
Hosp. Univ. Pta. de Hierro Majadahonda, Madrid, Spain
🇬🇧
Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom
🇫🇷
Hopital Beaujon, Clichy, France

and more 23 locations

A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection

Phase 2

Terminated

Conditions: Chronic Hepatitis b

Interventions: Drug: ATI-2173 25mg
Drug: Vebicorvir 300mg
Drug: Viread 300Mg Tablet

First Posted Date: 2022-02-14

Last Posted Date: 2022-05-31

Lead Sponsor: Antios Therapeutics, Inc

Target Recruit Count: 2

Registration Number: NCT05238844

Locations: 🇺🇦
Medical Center of Limited Liability Company "Harmoniya krasy", Kyiv, Ukraine
🇲🇩
Republican Clinical Hospital "Timofei Mosneaga" Arensia EM Unit, Chisinau, Republic Of Moldova, Moldova, Republic of

A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

Phase 1

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: JNJ-73763989
Biological: JNJ-64300535
Drug: ETV monohydrate
Drug: Tenofovir disoproxil
Drug: TAF

First Posted Date: 2021-11-17

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 24

Registration Number: NCT05123599

Locations: 🇮🇹
Irccs Ospedale Maggiore Di Milano, Milano, Italy
🇳🇿
New Zealand Clinical Research, Auckland, New Zealand
🇵🇱
ID Clinic, Myslowice, Poland

and more 10 locations

COVID-19 VaccinE Response in Rheumatology Patients

Phase 4

Completed

Conditions: Psoriatic Arthritis
Spondylarthritis
Rheumatoid Arthritis

Interventions: Drug: TNF Inhibitor
Drug: Canakinumab Injection
Drug: Tofacitinib
Drug: Ixekizumab
Drug: Upadacitinib
Drug: Abatacept
Drug: Secukinumab
Drug: Baricitinib

First Posted Date: 2021-10-15

Last Posted Date: 2025-05-02

Lead Sponsor: Jeffrey Curtis

Target Recruit Count: 841

Registration Number: NCT05080218

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Illumination Health/Bendcare, Hoover, Alabama, United States
🇺🇸
Rheumatology Care Center, Hoover, Alabama, United States

and more 5 locations

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection

Phase 2

Terminated

Conditions: Hepatitis B, Chronic

Interventions: Drug: JNJ-73763989
Drug: PegIFN-alpha-2a
Drug: Tenofovir disoproxil
Drug: TAF
Drug: ETV

First Posted Date: 2021-08-13

Last Posted Date: 2024-03-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 1

Registration Number: NCT05005507

Locations: 🇺🇸
I.D. Care, Inc., Hillsborough, New Jersey, United States
🇪🇸
Hosp. Univ. Vall D Hebron, Barcelona, Spain
🇪🇸
Hosp. Univ. Infanta Leonor, Madrid, Spain

and more 9 locations

Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis

Phase 4

Completed

Conditions: Enthesitis
Spondyloarthritis
Anti-Tumor Necrosis Factor Drugs

Interventions: Drug: TNF Inhibitor

First Posted Date: 2021-07-08

Last Posted Date: 2021-07-08

Lead Sponsor: Gunay ER

Target Recruit Count: 31

Registration Number: NCT04953871

PK of TAF and TDF for PrEP in Pregnant and Postpartum Women

Phase 3

Completed

Conditions: Hiv

Interventions: Drug: Tenofovir Disoproxil Fumarate
Drug: Tenofovir alafenamide

First Posted Date: 2021-06-24

Last Posted Date: 2023-12-18

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 50

Registration Number: NCT04937881

Locations: 🇿🇦
Gugulethu Midwife Obstetric Unit, Cape Town, South Africa

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Completed

Conditions: Lactating Women on Select DOI
Breastmilk Fed Infants of Mothers on Select DOI
HIV Infections

Interventions: Drug: Dolutegravir
Drug: Lamivudine
Drug: Emtricitabine
Drug: Tenofovir Disoproxil Fumarate

First Posted Date: 2021-04-28

Last Posted Date: 2025-02-06

Lead Sponsor: Duke University

Target Recruit Count: 164

Registration Number: NCT04862975

Locations: 🇿🇦
Botswana-UPenn Partnership, Botswana, Gaborone, South Africa
🇿🇦
Lesirane Clinic, Botswana, Gaborone, South Africa
🇿🇦
Mogoditshane Clinic KDC, Botswana, Gaborone, South Africa

and more 1 locations

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