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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR TENOFOVIR DISOPROXIL FUMARATE


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505(b)(2) Clinical Trials for Tenofovir Disoproxil Fumarate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Merck Sharp & Dohme Corp. N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Kirby Institute N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Formulation NCT02583464 ↗ Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Completed Laboratorio Elea Phoenix S.A. Phase 1 2014-09-01 Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tenofovir Disoproxil Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002396 ↗ The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients Unknown status Gilead Sciences Phase 1 1969-12-31 To evaluate the safety of single and multiple doses (28 daily doses) of 9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients. To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cells/mm3.
NCT00002415 ↗ Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients Completed Gilead Sciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
NCT00002450 ↗ Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients Completed Gilead Sciences Phase 3 1969-12-31 The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 109
Chronic Hepatitis B 51
HIV 45
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Condition MeSH

Condition MeSH for Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 153
Hepatitis B 109
Hepatitis 109
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Clinical Trial Locations for Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Tenofovir Disoproxil Fumarate
Location Trials
China 155
Canada 127
Spain 73
United Kingdom 67
South Africa 67
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Trials by US State

Trials by US State for Tenofovir Disoproxil Fumarate
Location Trials
California 106
New York 86
Florida 75
Texas 68
Massachusetts 62
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Clinical Trial Progress for Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Phase 4 97
Phase 3 96
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Completed 241
Recruiting 49
Unknown status 27
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Clinical Trial Sponsors for Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Tenofovir Disoproxil Fumarate
Sponsor Trials
Gilead Sciences 113
National Institute of Allergy and Infectious Diseases (NIAID) 68
Merck Sharp & Dohme Corp. 17
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Sponsor Type

Sponsor Type for Tenofovir Disoproxil Fumarate
Sponsor Trials
Other 371
Industry 230
NIH 90
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