Tenofovir

Generic Name: Tenofovir

Brand Names: Vemlidy, Tenofovir disoproxil Zentiva

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₄N_₅O_₄P

CAS Number: 147127-20-6

Unique Ingredient Identifier: W4HFE001U5

Background: Tenofovir is an acyclic nucleotide diester analog of adenosine monophosphate. In the most strict sense and due to the fact that it presents a phosphate group bound to the nitrogenous base, it is determined as an actual nucleotide analog. The antiviral activities of tenofovir were first reported in 1993 and this agent was commercially available since 2008 in the form of tenofovir disoproxil and tenofovir alafenamide in order to obtain oral bioavailability.

Indication: Tenofovir has been shown to be effective against HIV, herpes simplex virus-2, and hepatitis B virus.

To know more about the specific product indications, please visit the information in the orally available forms of tenofovir, tenofovir alafenamide and tenofovir disoproxil.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation

Not Applicable

Completed

Conditions: Healthy Volunteers
Pharmacokinetics

Interventions: Drug: TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA]
Device: Proteus Sensor System

First Posted Date: 2016-11-18

Last Posted Date: 2020-03-06

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 25

Registration Number: NCT02968576

A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants

Phase 1

Completed

Conditions: Healthy Adult Females

Interventions: Drug: Tenofovir
Drug: Maraviroc

First Posted Date: 2014-01-17

Last Posted Date: 2014-06-19

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 6

Registration Number: NCT02039323

Locations: 🇺🇸
CTRC University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

Phase 3

Active, not recruiting

Conditions: Chronic Hepatitis B

Interventions: Drug: Tenofovir DF
Drug: TDF Placebo

First Posted Date: 2012-07-27

Last Posted Date: 2025-01-08

Lead Sponsor: Gilead Sciences

Target Recruit Count: 90

Registration Number: NCT01651403

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇮🇳
SMS Medical College and Hospital, Jaipur, Rajasthan, India
🇷🇴
Grigore Alexandrescu Emergency Clinical Hospital for Children, Bucharest, Romania

and more 18 locations

Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women

Phase 2

Withdrawn

Conditions: HIV Infections

Interventions: Drug: 1% tenofovir gel
Drug: Placebo gel

First Posted Date: 2011-12-13

Last Posted Date: 2021-11-01

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Registration Number: NCT01490671

Single Dose Truvada in HIV-negative Men and Women

Completed

Conditions: Pharmacokinetic Study in Healthy Volunteers

Interventions: Drug: tenofovir + emtricitabine

First Posted Date: 2011-03-30

Last Posted Date: 2012-10-10

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 12

Registration Number: NCT01326221

Locations: 🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States

Comparative Safety Study of Two Vaginal Applicators With Tenofovir

Not Applicable

Completed

Conditions: Microbicide Applicator

Interventions: Drug: Tenofovir

First Posted Date: 2011-01-26

Last Posted Date: 2012-07-16

Lead Sponsor: PATH

Target Recruit Count: 25

Registration Number: NCT01283555

Locations: 🇩🇴
Clinica Profamilia, Santo Domingo, Dominican Republic

Tenofovir Gel in Pregnancy and Lactation

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Tenofovir 1% gel
Other: Placebo gel

First Posted Date: 2010-06-03

Last Posted Date: 2021-10-25

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 232

Registration Number: NCT01136759

Locations: 🇺🇸
Alabama CRS, Birmingham, Alabama, United States
🇺🇸
University of Pittsburgh CRS, Pittsburgh, Pennsylvania, United States

Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

Completed

Conditions: HIV Infections

Interventions: Drug: Tenofovir disoproxil fumarate (TDF)

First Posted Date: 2010-02-10

Last Posted Date: 2022-09-23

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 1765

Registration Number: NCT01066858

Locations: 🇺🇬
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Mpigi, Uganda
🇿🇦
Umlazi CRS, Durban, KwaZulu-Natal, South Africa
🇿🇦
Durban Paediatric HIV CRS, Durban, KwaZulu-Natal, South Africa

and more 8 locations

Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Emtricitabine (FTC)
Drug: Tenofovir disoproxil fumarate (TDF)
Drug: Efavirenz (EFV)
Drug: Truvada

First Posted Date: 2009-12-25

Last Posted Date: 2016-12-16

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 34

Registration Number: NCT01040091

Locations: 🇺🇸
University of Colorado CTRC CRS, Aurora, Colorado, United States

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Completed

Conditions: HIV Infections

Interventions: Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
Drug: Tenofovir disoproxil fumarate
Drug: Tenofovir disoproxil fumarate placebo

First Posted Date: 2008-08-07

Last Posted Date: 2023-02-08

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 518

Registration Number: NCT00729573

Locations: 🇿🇼
Seke South CRS, Chitungwiza, Zimbabwe
🇺🇬
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda
🇿🇼
Zengeza CRS, Chitungwiza, Zimbabwe

and more 1 locations

Drug Development Updates

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