Clinical trials: Tenofovir Alafenamide Fumarate
HIV-1 Infection
Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside…
- Trial name
- NCT02345226
- Testing
- FTC/RPV/TAF, EFV/FTC/TDF
- Where
- 117 sites in United States, Belgium and 7 more
- Volunteers
- 881 people
- Sponsor
- Gilead Sciences
HIV/AIDS, Antiviral Toxicity
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear.
- Conditions
- HIV/AIDS, Antiviral Toxicity, Antiviral Drug Adverse Reaction, Mitochondrial Alteration
- Trial name
- UCLACAREMITO (NCT03251144)
- Testing
- Switch to E/C/FTC/TAF daily
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV-1 Infection
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination…
- Trial name
- NCT03405935
- Testing
- B/F/TAF
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 86 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with…
- Trial name
- NCT02979613
- Testing
- TAF, TDF
- Where
- 39 sites in United States, Canada and 6 more
- Volunteers
- 490 people
- Sponsor
- Gilead Sciences
HIV/AIDS, Tuberculosis, Pulmonary
INSTI's For The Management of HIV-associated TB
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected…
- Trial name
- INSIGHT (NCT04734652)
- Testing
- Biktarvy®, TLD- fixed-drug combination single tablet
- Where
- South Africa
- Volunteers
- 122 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
HIV, HIV Infections
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
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…
- Trial name
- NCT01797445
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Canada and 9 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
HIV-1-infection
B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV.
- Trial name
- NCT03532425
- Testing
- B/F/TAF, Atripla
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- University of Alberta
HIV, HIV Infections
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
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…
- Trial name
- NCT01780506
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Australia and 10 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
HIV-1/HBV Co-Infection
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- Alliance (NCT03547908)
- Testing
- B/F/TAF, DTG, F/TDF
- Where
- 69 sites in United States, China and 12 more
- Volunteers
- 244 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- NCT03110380
- Testing
- B/F/TAF, F/TAF, DTG
- Where
- 94 sites in United States, Austria and 4 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone…
- Trial name
- NCT02616783
- Testing
- E/C/F/TAF, TDF, FTC
- Where
- 35 sites in Belgium, France and 3 more
- Volunteers
- 167 people
- Sponsor
- Gilead Sciences
Immunodeficiency Virus Type 1, Human
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC…
- Trial name
- NCT02431247
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, DRV/COBI FDC, FTC/TDF FDC
- Where
- 80 sites in United States, Belgium and 8 more
- Volunteers
- 725 people
- Sponsor
- Janssen Sciences Ireland UC
HBeAg-positive Chronic Hepatitis B
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT01940471
- Testing
- TAF, TDF
- Where
- 160 sites in United States, Australia and 17 more
- Volunteers
- 875 people
- Sponsor
- Gilead Sciences
Hiv, Weight Gain
Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF?
Weight gain with the integrase inhibitors and tenofovir alafenamide has been observed in observational cohorts and randomized controlled clinical trials.
- Trial name
- DeLiTE (NCT04665375)
- Testing
- DOR/3TC/TDF
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University Health Network, Toronto
Acquired Immunodeficiency Syndrome, HIV Infections
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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…
- Trial name
- NCT01497899
- Testing
- E/C/F/TDF, E/C/F/TAF
- Where
- 41 sites in United States, Puerto Rico
- Volunteers
- 279 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of…
- Trial name
- NCT02652624
- Testing
- E/C/F/TAF, E/C/F/TDF, ATV
- Where
- 56 sites in United States, Dominican Republic and 4 more
- Volunteers
- 472 people
- Sponsor
- Gilead Sciences
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836236
- Testing
- TAF, TDF
- Where
- 29 sites in China
- Volunteers
- 155 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic…
- Trial name
- NCT02862548
- Testing
- TAF, TDF, Other approved antivirals
- Where
- New Zealand
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus Type 1
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF)…
- Trial name
- NCT02269917
- Testing
- D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
- Where
- 79 sites in United States, Belgium and 8 more
- Volunteers
- 1,149 people
- Sponsor
- Janssen R&D Ireland