MedPath

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
C19H30N5O10P
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

HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil

Conditions
HIV
Drug
Resistance
Interventions
First Posted Date
2020-07-01
Last Posted Date
2020-07-24
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
2500
Registration Number
NCT04453436

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection

Phase 2
Completed
Conditions
Hepatitis B, Chronic
Interventions
First Posted Date
2020-06-19
Last Posted Date
2025-03-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
54
Registration Number
NCT04439539
Locations
🇬🇧

Kings College Hospital, London, United Kingdom

🇬🇧

Grahame Hayton Unit, London, United Kingdom

🇺🇸

Ruane Clinical Research Group Inc, Los Angeles, California, United States

and more 44 locations

Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

Phase 3
Conditions
HIV-infection/Aids
Interventions
First Posted Date
2020-03-11
Last Posted Date
2020-03-11
Lead Sponsor
HeNan Sincere Biotech Co., Ltd
Target Recruit Count
720
Registration Number
NCT04303598
Locations
🇨🇳

Beijing DiTan Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

Guangzhou Eighth People's Hospital, Guangzhou, Guangdong, China

🇨🇳

Chongqing Public Health Medical Center, Chongqing, Chongqing, China

and more 9 locations

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Not Applicable
Conditions
Hepatitis B
Compensated Cirrhosis
Interventions
First Posted Date
2019-12-12
Last Posted Date
2019-12-12
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
150
Registration Number
NCT04196998
Locations
🇨🇳

Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

Not Applicable
Recruiting
Conditions
Chronic Hepatitis b
Interventions
First Posted Date
2019-12-11
Last Posted Date
2019-12-17
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Target Recruit Count
300
Registration Number
NCT04195074
Locations
🇨🇳

Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis

Conditions
Hepatocellular Carcinoma
Compensated Cirrhosis
Hepatitis B, Chronic
Interventions
First Posted Date
2019-11-13
Last Posted Date
2019-11-13
Lead Sponsor
Qing XIe
Target Recruit Count
4000
Registration Number
NCT04160897
Locations
🇨🇳

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

Conditions
Chronic Hepatitis B Infection
High Viral Load
Interventions
First Posted Date
2019-10-22
Last Posted Date
2019-10-22
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
440
Registration Number
NCT04135235
Locations
🇨🇳

Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing, China

Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B.

Phase 2
Completed
Conditions
Hepatitis B
Tenofovir
Pregnancy
Interventions
First Posted Date
2019-10-03
Last Posted Date
2024-03-27
Lead Sponsor
University of Oxford
Target Recruit Count
27
Registration Number
NCT04114890
Locations
🇹🇭

Shoklo Malaria Research unit (SMRU) clinics, Mae sot, Tak, Thailand

A Study of Baricitinib in Participants With Rheumatoid Arthritis

Phase 4
Recruiting
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2019-09-12
Last Posted Date
2025-04-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1300
Registration Number
NCT04086745
Locations
🇺🇸

Arizona Research Clinic PLLC, Chandler, Arizona, United States

🇺🇸

Smart Cures Clinical Research, Anaheim, California, United States

🇺🇸

Wallace Rheumatic Study Center, Beverly Hills, California, United States

and more 116 locations

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Phase 4
Active, not recruiting
Conditions
HBV Coinfection
HCC
Interventions
First Posted Date
2019-07-25
Last Posted Date
2022-05-25
Lead Sponsor
West China Hospital
Target Recruit Count
104
Registration Number
NCT04032860
Locations
🇨🇳

West China Hospital, Sichuan University, Chengdu, Sichuan, China

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