CLINICAL TRIALS PROFILE FOR EMTRICITABINE

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 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.
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.

All Clinical Trials for EMTRICITABINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002335 ↗	The Safety and Effectiveness of 524W91	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.
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.
NCT00002416 ↗	Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination	Completed	Triangle Pharmaceuticals	Phase 3	1969-12-31	The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.
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.

Clinical Trial Conditions for EMTRICITABINE

Condition Name

Condition Name for EMTRICITABINE
Intervention	Trials
HIV Infections	168
HIV	96
HIV-1 Infection	46
HIV Infection	34

Condition MeSH

Condition MeSH for EMTRICITABINE
Intervention	Trials
HIV Infections	262
Acquired Immunodeficiency Syndrome	102
Infections	81
Infection	60

Clinical Trial Locations for EMTRICITABINE

Trials by Country

Trials by Country for EMTRICITABINE
Location	Trials
Canada	168
Spain	121
France	118
South Africa	110
Germany	104

Trials by US State

Trials by US State for EMTRICITABINE
Location	Trials
California	140
Florida	115
Texas	108
New York	100
North Carolina	92

Clinical Trial Progress for EMTRICITABINE

Clinical Trial Phase

Clinical Trial Phase for EMTRICITABINE
Clinical Trial Phase	Trials
Phase 4	161
Phase 3	130
Phase 2/Phase 3	22

Clinical Trial Status

Clinical Trial Status for EMTRICITABINE
Clinical Trial Phase	Trials
Completed	319
Recruiting	50
Not yet recruiting	33

Clinical Trial Sponsors for EMTRICITABINE

Sponsor Name

Sponsor Name for EMTRICITABINE
Sponsor	Trials
Gilead Sciences	144
National Institute of Allergy and Infectious Diseases (NIAID)	62
Merck Sharp & Dohme Corp.	38

Sponsor Type

Sponsor Type for EMTRICITABINE
Sponsor	Trials
Other	605
Industry	366
NIH	93