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

A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV

Phase 2
Completed
Conditions
HIV Infections
Hepatitis B
First Posted Date
2002-04-09
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
90
Registration Number
NCT00033163
Locations
🇺🇸

Northwestern University CRS, Chicago, Illinois, United States

🇺🇸

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

🇺🇸

Univ. of Cincinnati CRS, Cincinnati, Ohio, United States

and more 12 locations

Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2001-12-28
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
56
Registration Number
NCT00028366
Locations
🇺🇸

USC CRS, Los Angeles, California, United States

🇺🇸

The Ponce de Leon Ctr. CRS, Atlanta, Georgia, United States

🇺🇸

Case CRS, Cleveland, Ohio, United States

and more 10 locations

Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-12-05
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
53
Registration Number
NCT00027339
Locations
🇺🇸

USC CRS, Los Angeles, California, United States

🇺🇸

UC Davis Medical Center, Sacramento, California, United States

🇺🇸

Beth Israel Med. Ctr., ACTU, New York, New York, United States

and more 11 locations

The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

Phase 3
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Registration Number
NCT00007436
Locations
🇺🇸

Northstar Med Clinic, Chicago, Illinois, United States

🇺🇸

Anderson Clinical Research, Pittsburgh, Pennsylvania, United States

🇺🇸

Physicans Home Service, Washington, District of Columbia, United States

and more 16 locations

Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

Phase 3
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
600
Registration Number
NCT00002450
Locations
🇺🇸

Tower Infectious Diseases / Med Associates Inc, Los Angeles, California, United States

🇺🇸

Remington Davis Inc, Columbus, Ohio, United States

🇺🇸

Thomas Street Clinic, Houston, Texas, United States

and more 58 locations

Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
175
Registration Number
NCT00002415
Locations
🇺🇸

Harbor UCLA Med Ctr, Torrance, California, United States

🇺🇸

Hershey Med Ctr, Hershey, Pennsylvania, United States

🇺🇸

San Francisco Veterans Adm Med Cntr, San Francisco, California, United States

and more 21 locations

Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Registration Number
NCT00016588
Locations
🇺🇸

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York, New York, United States

A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
300
Registration Number
NCT00002453
Locations
🇺🇸

Tenofovir Coordinating Center, Foster City, California, United States

Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations

Not Applicable
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Registration Number
NCT00011089
Locations
🇺🇸

Medical Information, Foster City, California, United States

The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients

Phase 1
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
60
Registration Number
NCT00002396
Locations
🇺🇸

San Francisco Gen Hosp, San Francisco, California, United States

🇺🇸

Johns Hopkins Hosp, Baltimore, Maryland, United States

🇺🇸

Univ of Washington / AIDS Clinical Trial Unit, Seattle, Washington, United States

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