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

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Recruiting

Conditions: Liver Failure
Virus Diseases
Hepatitis B

Interventions: Drug: Tenofovir Alafenamide
Drug: Tenofovir disoproxil fumarate
Drug: Entecavir

First Posted Date: 2018-08-21

Last Posted Date: 2023-02-09

Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Target Recruit Count: 200

Registration Number: NCT03640728

Locations: 🇨🇳
The Affiliated Hospital of Yan'an University, Yan'an, China
🇨🇳
Hanzhong Infectious Hospital, Hanzhong, China
🇨🇳
Weinan Central Hospital, Weinan, China

and more 8 locations

A Study in Healthy Volunteers

Phase 1

Completed

Conditions: Liver Diseases
Hepatitis B
Infectious Disease

Interventions: Drug: TDF
Drug: CRV431
Drug: Placebo

First Posted Date: 2018-07-24

Last Posted Date: 2021-12-01

Lead Sponsor: Hepion Pharmaceuticals, Inc.

Target Recruit Count: 92

Registration Number: NCT03596697

Locations: 🇺🇸
Pinnacle Clinical Research, San Antonio, Texas, United States
🇺🇸
Celerion, Inc, Lincoln, Nebraska, United States

Arresting Vertical Transmission of Hepatitis B Virus

Phase 4

Completed

Conditions: Hepatitis B
Vertical Transmission of Infectious Disease

Interventions: Drug: Tenofovir Disoproxil Fumarate
Biological: Monovalent HBV vaccine

First Posted Date: 2018-06-25

Last Posted Date: 2021-02-24

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 179

Registration Number: NCT03567382

Locations: 🇨🇩
Kinshasa School of Public Health, Kinshasa, Congo, The Democratic Republic of the

A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Raltegravir
Drug: Tenofovir Disoproxil Fumarate
Drug: Narlaprevir
Drug: Ritonavir

First Posted Date: 2018-05-25

Last Posted Date: 2019-02-19

Lead Sponsor: R-Pharm

Target Recruit Count: 36

Registration Number: NCT03537404

Locations: 🇷🇺
Clinic "Bessalar" JSC, Moscow, Russian Federation

Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

Phase 4

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: Tenofovir Disoproxil
Drug: Tenofovir Disoproxil Fumarate

First Posted Date: 2018-04-02

Last Posted Date: 2022-06-09

Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Target Recruit Count: 189

Registration Number: NCT03485534

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

Phase 4

Completed

Conditions: Axial Spondyloarthritis

Interventions: Drug: Secukinumab
Drug: TNF blocker
Biological: blood specimen

First Posted Date: 2018-02-26

Last Posted Date: 2024-11-18

Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Target Recruit Count: 300

Registration Number: NCT03445845

Locations: 🇫🇷
CHU d'Angers, Angers, France
🇫🇷
CHRU Besançon, Besançon, France
🇫🇷
APHP- Hôpital Avicenne, Bobigny, France

and more 32 locations

Modifiers of Tenofovir in the Female Genital Tract

Completed

Conditions: HIV/AIDS
Contraception

Interventions: Drug: Tenofovir Disoproxil Fumarate
Drug: Depo-Provera

First Posted Date: 2017-12-19

Last Posted Date: 2018-05-01

Lead Sponsor: University of Minnesota

Target Recruit Count: 50

Registration Number: NCT03377608

Locations: 🇺🇬
MU-JHU Care Ltd, Kampala, Uganda

A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B

Phase 4

Conditions: Chronic Hepatitis B

Interventions: Drug: Entecavir
Drug: Pegylated interferon
Drug: Tenofovir disoproxil fumarate

First Posted Date: 2017-11-30

Last Posted Date: 2018-04-25

Lead Sponsor: Tongji Hospital

Target Recruit Count: 2000

Registration Number: NCT03357822

Locations: 🇨🇳
BeiJing YouAn Hospital, Capital Medical University, Beijing, Beijing, China
🇨🇳
The First Hospital Affiliated to AMU, Chongqing, Chongqing, China
🇨🇳
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

and more 9 locations