CLINICAL TRIALS PROFILE FOR TENOFOVIR ALAFENAMIDE

All Clinical Trials for TENOFOVIR ALAFENAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036634 ↗	A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients	Completed	Gilead Sciences	Phase 1/Phase 2	2002-03-01	This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
NCT01497899 ↗	Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2011-12-28	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
NCT01565850 ↗	D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults	Completed	Gilead Sciences	Phase 2	2012-04-01	This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
NCT01780506 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2012-12-26	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01797445 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2013-03-12	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01815736 ↗	Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants	Completed	Gilead Sciences	Phase 3	2013-03-27	The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

Clinical Trial Conditions for TENOFOVIR ALAFENAMIDE

Condition Name

Condition Name for TENOFOVIR ALAFENAMIDE
Intervention	Trials
HIV Infections	36
Hiv	29
HIV-1 Infection	24
HIV-1-infection	22

Condition MeSH

Condition MeSH for TENOFOVIR ALAFENAMIDE
Intervention	Trials
HIV Infections	54
Hepatitis B	54
Hepatitis	48
Hepatitis B, Chronic	35

Clinical Trial Locations for TENOFOVIR ALAFENAMIDE

Trials by Country

Trials by Country for TENOFOVIR ALAFENAMIDE
Location	Trials
United States	828
Canada	99
China	83
France	67
Spain	55

Trials by US State

Trials by US State for TENOFOVIR ALAFENAMIDE
Location	Trials
California	61
Texas	52
Florida	51
Georgia	43
New York	41

Clinical Trial Progress for TENOFOVIR ALAFENAMIDE

Clinical Trial Phase

Clinical Trial Phase for TENOFOVIR ALAFENAMIDE
Clinical Trial Phase	Trials
Phase 4	74
Phase 3	62
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for TENOFOVIR ALAFENAMIDE
Clinical Trial Phase	Trials
Completed	71
Recruiting	67
Not yet recruiting	34

Clinical Trial Sponsors for TENOFOVIR ALAFENAMIDE

Sponsor Name

Sponsor Name for TENOFOVIR ALAFENAMIDE
Sponsor	Trials
Gilead Sciences	85
ViiV Healthcare	7
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for TENOFOVIR ALAFENAMIDE
Sponsor	Trials
Other	267
Industry	140
NIH	9