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.

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.

Clinical Trial Conditions for Emtricitabine

Condition Name

Condition Name for Emtricitabine
Intervention	Trials
HIV Infections	162
HIV	91
HIV-1 Infection	44

Condition MeSH

Condition MeSH for Emtricitabine
Intervention	Trials
HIV Infections	253
Acquired Immunodeficiency Syndrome	100
Infections	80

Clinical Trial Locations for Emtricitabine

Trials by Country

Trials by Country for Emtricitabine
Location	Trials
Canada	166
Spain	117
France	114
South Africa	109
Germany	101

Trials by US State

Trials by US State for Emtricitabine
Location	Trials
California	137
Florida	114
Texas	107
New York	100
North Carolina	91

Clinical Trial Progress for Emtricitabine

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine
Clinical Trial Phase	Trials
Phase 4	155
Phase 3	123
Phase 2/Phase 3	22

Clinical Trial Status

Clinical Trial Status for Emtricitabine
Clinical Trial Phase	Trials
Completed	319
Recruiting	45
Unknown status	33

Clinical Trial Sponsors for Emtricitabine

Sponsor Name

Sponsor Name for Emtricitabine
Sponsor	Trials
Gilead Sciences	138
National Institute of Allergy and Infectious Diseases (NIAID)	61
Merck Sharp & Dohme Corp.	38

Sponsor Type

Sponsor Type for Emtricitabine
Sponsor	Trials
Other	573
Industry	354
NIH	91