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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

Optimization of Antiretroviral Therapy

Phase 4
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2016-10-17
Last Posted Date
2020-02-18
Lead Sponsor
Shanghai Public Health Clinical Center
Target Recruit Count
184
Registration Number
NCT02935075
Locations
🇨🇳

Yunnan AIDS care center, Kunming, Yunnan, China

🇨🇳

The Second Hospital of Nanjing, Nanjing, Jiangsu, China

🇨🇳

Shanghai Public Health Clinical Center, Shanghai, Shanghai, China

Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France

Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2016-10-07
Last Posted Date
2016-10-07
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
Target Recruit Count
813
Registration Number
NCT02927535

Evaluation of Tumour Necrosis Factor Alpha (TNFα) Blockers in Early Rheumatoid Arthritis in France

Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2016-10-07
Last Posted Date
2016-10-07
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
Target Recruit Count
813
Registration Number
NCT02927509

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

Phase 1
Completed
Conditions
Hepatitis
Interventions
First Posted Date
2016-09-30
Last Posted Date
2017-01-26
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
Target Recruit Count
50
Registration Number
NCT02920931
Locations
🇰🇷

ChungNam university hospital, ChungNam, Korea, Republic of

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Phase 1
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2016-09-20
Last Posted Date
2019-04-04
Lead Sponsor
Assembly Biosciences
Target Recruit Count
86
Registration Number
NCT02908191

PK and PD Study of Oral F/TAF for HIV Prevention

First Posted Date
2016-09-19
Last Posted Date
2018-02-19
Lead Sponsor
CONRAD
Target Recruit Count
73
Registration Number
NCT02904369
Locations
🇺🇸

Eastern Virginia Medical School Clinical Research Center, Norfolk, Virginia, United States

🇺🇸

Magee-Womens Research Institute and Foundation, Pittsburgh, Pennsylvania, United States

🇩🇴

Profamilia, Santo Domingo, Dominican Republic

Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: HUG116 tablet 245mg
First Posted Date
2016-09-15
Last Posted Date
2018-04-12
Lead Sponsor
Huons Co., Ltd.
Target Recruit Count
50
Registration Number
NCT02902523
Locations
🇰🇷

Huons, Seongnam-si, Gyeonggi-do, Korea, Republic of

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

Phase 2
Completed
Conditions
Chronic Hepatitis B
Interventions
Drug: Other approved antivirals
First Posted Date
2016-08-11
Last Posted Date
2022-06-08
Lead Sponsor
Gilead Sciences
Target Recruit Count
51
Registration Number
NCT02862548
Locations
🇳🇿

Auckland City Hospital, Auckland, New Zealand

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2016-08-11
Last Posted Date
2018-06-27
Lead Sponsor
Gilead Sciences
Target Recruit Count
15
Registration Number
NCT02862574
Locations
🇺🇸

Albuquerque Center for Rheumatology, Albuquerque, New Mexico, United States

🇺🇸

Omega Research Consultants, LLC, DeBary, Florida, United States

🇺🇸

Stanford University, Palo Alto, California, United States

and more 5 locations

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)

Phase 3
Completed
Conditions
HBV
Chronic HBV Infection
Interventions
Drug: TAF Placebo
Drug: TDF Placebo
First Posted Date
2016-07-18
Last Posted Date
2024-10-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
181
Registration Number
NCT02836249
Locations
🇨🇳

Beijing Ditan Hospital, Beijing, China

🇨🇳

PLA 302 Hospital, Beijing, China

🇨🇳

Beijing Friendship Hospital, Capital Medical University, Beijing, China

and more 22 locations
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