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CLINICAL TRIALS PROFILE FOR EMTRIVA

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Clinical Trials for Emtriva

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00112047	Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects	Completed	Gilead Sciences	Phase 3	The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
NCT00344981	Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression	Completed	University of Maryland	N/A	Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.
NCT00381303	GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.	Completed	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	Phase 3	The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

Clinical Trial Conditions for Emtriva

Condition Name

Condition Name for Emtriva
Intervention	Trials
HIV Infections	4
HIV-1-infection	1
HIV Infection	1

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Condition MeSH

Condition MeSH for Emtriva
Intervention	Trials
HIV Infections	5
Acquired Immunodeficiency Syndrome	2
Infection	1

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Clinical Trial Locations for Emtriva

Trials by Country

Trials by Country for Emtriva
Location	Trials
United States	32
Canada	2
Puerto Rico	1

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Trials by US State

Trials by US State for Emtriva
Location	Trials
Maryland	3
California	3
New York	2
Missouri	2
North Carolina	2

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Clinical Trial Progress for Emtriva

Clinical Trial Phase

Clinical Trial Phase for Emtriva
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	1
N/A	2

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Clinical Trial Status

Clinical Trial Status for Emtriva
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
Not yet recruiting	1

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Clinical Trial Sponsors for Emtriva

Sponsor Name

Sponsor Name for Emtriva
Sponsor	Trials
Gilead Sciences	2
National Institute of Mental Health (NIMH)	1
Tibotec, Inc	1

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Sponsor Type

Sponsor Type for Emtriva
Sponsor	Trials
Industry	5
Other	3
NIH	2

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