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Last Updated: May 11, 2021

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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.
NCT00017992 Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV Unknown status Triangle Pharmaceuticals Phase 2 1969-12-31 The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Emtricitabine

Condition Name

Condition Name for Emtricitabine
Intervention Trials
HIV Infections 144
HIV 86
HIV-1 Infection 40
HIV Infection 34
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Condition MeSH

Condition MeSH for Emtricitabine
Intervention Trials
HIV Infections 225
Acquired Immunodeficiency Syndrome 84
Infection 55
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 89
United Kingdom 85
France 78
Germany 74
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Trials by US State

Trials by US State for Emtricitabine
Location Trials
California 122
Florida 102
Texas 95
New York 90
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 4 144
Phase 3 118
Phase 2/Phase 3 18
[disabled in preview] 122
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Clinical Trial Status

Clinical Trial Status for Emtricitabine
Clinical Trial Phase Trials
Completed 199
Not yet recruiting 81
Recruiting 73
[disabled in preview] 89
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Clinical Trial Sponsors for Emtricitabine

Sponsor Name

Sponsor Name for Emtricitabine
Sponsor Trials
Gilead Sciences 130
National Institute of Allergy and Infectious Diseases (NIAID) 55
Merck Sharp & Dohme Corp. 36
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Sponsor Type

Sponsor Type for Emtricitabine
Sponsor Trials
Other 464
Industry 323
NIH 75
[disabled in preview] 7
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