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Last Updated: August 8, 2020

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CLINICAL TRIALS PROFILE FOR EMTRICITABINE

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505(b)(2) Clinical Trials for Emtricitabine

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

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002362 A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Suspended Triangle Pharmaceuticals Phase 3 1999-08-01 This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
NCT00006144 A Study of HIV-Disease Development in Aging Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2000-10-01 The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
NCT00006208 A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs Unknown status Triangle Pharmaceuticals Phase 3 2000-08-01 The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
NCT00016718 Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 2001-08-01 Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.
NCT00016718 Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 2001-08-01 Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Emtricitabine

Condition Name

Condition Name for Emtricitabine
Intervention Trials
HIV Infections 139
HIV 84
HIV-1 Infection 39
HIV Infection 34
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Condition MeSH

Condition MeSH for Emtricitabine
Intervention Trials
HIV Infections 220
Acquired Immunodeficiency Syndrome 83
Infection 54
Immunologic Deficiency Syndromes 46
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Clinical Trial Locations for Emtricitabine

Trials by Country

Trials by Country for Emtricitabine
Location Trials
Canada 138
Spain 88
United Kingdom 85
France 75
Germany 74
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Trials by US State

Trials by US State for Emtricitabine
Location Trials
California 118
Florida 100
Texas 94
New York 88
North Carolina 83
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Clinical Trial Progress for Emtricitabine

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine
Clinical Trial Phase Trials
Phase 4 138
Phase 3 114
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Emtricitabine
Clinical Trial Phase Trials
Completed 199
Not yet recruiting 71
Recruiting 65
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Clinical Trial Sponsors for Emtricitabine

Sponsor Name

Sponsor Name for Emtricitabine
Sponsor Trials
Gilead Sciences 128
National Institute of Allergy and Infectious Diseases (NIAID) 54
Merck Sharp & Dohme Corp. 34
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Sponsor Type

Sponsor Type for Emtricitabine
Sponsor Trials
Other 428
Industry 314
NIH 74
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