Clinical trials: Tenofovir
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, HIV Infections
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC)…
- Trial name
- NCT01108510
- Testing
- COBI, RTV, ATV
- Where
- 134 sites in United States, Australia and 17 more
- Volunteers
- 698 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus, HIV Infections
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine…
- Trial name
- NCT01910402
- Testing
- Dolutegravir/abacavir/lamivudine FDC, Atazanavir, Ritonavir
- Where
- 90 sites in United States, Argentina and 11 more
- Volunteers
- 499 people
- Sponsor
- ViiV Healthcare
Healthy Volunteers
Analysis of Crushed and Whole Tablet Genvoya
Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet.
- Trial name
- NCT03717129
- Testing
- Genvoya Oral dose, Genvoya Crushed Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV
BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an…
- Trial name
- BATAR (NCT00931801)
- Testing
- atazanavir/raltegravir, atazanavir/tenofovir/emtricitabine
- Where
- 9 sites in United States
- Volunteers
- 43 people
- Sponsor
- Community Research Initiative of New England
HIV-1
Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen
The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in children and adolescents with HIV-1 who are virologically suppressed (defined…
- Trial name
- NCT02285114
- Testing
- F/TAF, 3rd ARV agent, Boosted PIs
- Where
- 8 sites in United States, Panama and 1 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue.
- Trial name
- NCT01480284
- Testing
- GSK548470 300 mg tablet, ETV 0.5 mg capsule
- Where
- 32 sites in Japan
- Volunteers
- 166 people
- Sponsor
- GlaxoSmithKline
HIV Infection
Safety and Efficacy Study of Switching From Epzicom to Truvada
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir…
- Trial name
- SWIFT (NCT00724711)
- Testing
- emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), abacavir (ABC)/lamivudine (3TC)
- Where
- 80 sites in United States, Canada and 1 more
- Volunteers
- 312 people
- Sponsor
- Gilead Sciences
Risk Reduction
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence.
- Trial name
- NCT05333679
- Testing
- UTRA, UTRA feedback
- Where
- South Africa
- Volunteers
- 200 people
- Sponsor
- University of California, San Francisco
Hepatitis B Virus
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs.
- Trial name
- NCT00805675
- Testing
- Telbivudine, Tenofovir, Telbivudine plus tenofovir
- Where
- China
- Volunteers
- 83 people
- Sponsor
- Novartis Pharmaceuticals
HIV-1 Infection
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and…
- Trial name
- NCT05630755
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 514 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV, HIV Infections
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in…
- Trial name
- EYEWITNESS (NCT05911360)
- Testing
- DTG/3TC
- Where
- 56 sites in United States, Austria and 10 more
- Volunteers
- 205 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection, HCV Infection
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir…
- Trial name
- Co-STARs (NCT02707601)
- Testing
- E/C/F/TAF, F/R/TAF, LDV/SOF
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
HIV
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of…
- Trial name
- NCT02276612
- Testing
- E/C/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 60 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment.
- Trial name
- NCT02174276
- Testing
- Tenofovir disoproxil fumarate, GS-4774
- Where
- 33 sites in United States, Canada and 4 more
- Volunteers
- 195 people
- Sponsor
- Gilead Sciences
Hepatitis B Virus
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe…
- Trial name
- NCT02296853
- Testing
- TAF
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with…
- Trial name
- NCT01525628
- Testing
- midazolam, BI 201335, tenofovir
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- Boehringer Ingelheim
Hepatitis B Virus (HBV)
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT00734162
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 21 sites in United States, Bulgaria and 5 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
HIV Infections
Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen
The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to…
- Trial name
- NCT02478632
- Testing
- Subjects do not receive study medication in this study 202094
- Where
- 32 sites in United States, Argentina and 4 more
- Volunteers
- 102 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus, Virus Shedding
The Compartmental Biology of HIV in the Male Genital Tract
Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood samples which will be analyzed to better understand the pharmacology of antiretroviral therapy in the male genital tract.
- Trial name
- NCT02638493
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill