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Last Updated: November 22, 2019

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CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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505(b)(2) Clinical Trials for Emtricitabine; 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 S.A.C.I.F. y 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 Emtricitabine; Tenofovir Disoproxil Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00039741 Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed PENTA Foundation Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00051831 Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed AIDS Clinical Trials Group N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00055120 When to Start Anti-HIV Drugs in Patients With Opportunistic Infections Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2003-03-01 The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
NCT00076791 Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 2004-03-01 Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Emtricitabine; Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Emtricitabine; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 60
HIV 23
HIV-1 Infection 15
HIV Infection 13
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Condition MeSH

Condition MeSH for Emtricitabine; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 87
Acquired Immunodeficiency Syndrome 34
Immunologic Deficiency Syndromes 23
Infection 14
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Clinical Trial Locations for Emtricitabine; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Emtricitabine; Tenofovir Disoproxil Fumarate
Location Trials
United States 833
Canada 72
United Kingdom 39
Germany 38
South Africa 36
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Trials by US State

Trials by US State for Emtricitabine; Tenofovir Disoproxil Fumarate
Location Trials
California 62
New York 48
Florida 47
North Carolina 45
Texas 44
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Clinical Trial Progress for Emtricitabine; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Phase 4 34
Phase 3 49
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Emtricitabine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Completed 83
Active, not recruiting 25
Recruiting 25
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Clinical Trial Sponsors for Emtricitabine; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Emtricitabine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Gilead Sciences 63
National Institute of Allergy and Infectious Diseases (NIAID) 40
AIDS Clinical Trials Group 11
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Sponsor Type

Sponsor Type for Emtricitabine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Other 113
Industry 106
NIH 51
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