Clinical trials: Tenofovir
Hepatitis B, Chronic
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment
- Trial name
- NCT03471624
- Testing
- Tenofovir Alafenamide
- Where
- 12 sites in United States, Japan and 2 more
- Volunteers
- 270 people
- Sponsor
- Stanford University
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.
- Trial name
- NCT01475851
- Testing
- GSK548470 300 mg tablet
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Hepatitis B Chronic Infection, Pregnancy
Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV).
- Trial name
- iTAP (NCT01745822)
- Testing
- tenofovir disoproxil fumarate
- Where
- 17 sites in Thailand
- Volunteers
- 654 people
- Sponsor
- Institut de Recherche pour le Developpement
HIV-1, HIV Infections
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive 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) plus darunavir (DRV) relative to current antiretroviral…
- Conditions
- HIV-1, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01968551
- Testing
- E/C/F/TAF, DRV, Baseline DRV- containing ARV regimen
- Where
- 62 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Gilead Sciences
Healthy Volunteers
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
Background: Human immunodeficiency virus (HIV) is treated with antiretroviral drugs. Many people with HIV also have the lung infection tuberculosis (TB). Most TB treatments are complicated.
- Trial name
- NCT03510468
- Testing
- Tenofovir alafenamide, Rifapentine, Isoniazid (INH)
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
HIV Infections
Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV).
- Trial name
- NCT03670355
- Testing
- Tenofovir (TFV) IVR
- Where
- 3 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir…
- Trial name
- NCT02345252
- Testing
- FTC/RPV/TAF, FTC/RPV/TDF
- Where
- 117 sites in United States, Belgium and 10 more
- Volunteers
- 632 people
- Sponsor
- Gilead Sciences
HIV, HBV
Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV)…
- Trial name
- NCT02071082
- Testing
- E/C/F/TAF
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 79 people
- Sponsor
- Gilead Sciences
HIV Infections
"The Once A Day Protease Inhibitor Regimens"
Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r).
- Trial name
- NCT00242216
- Testing
- ritonavir-boosted atazanavir, ritonavir-boosted fosamprenavir
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
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
HIV Infection
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
- Trial name
- NCT00131677
- Testing
- tenofovir disoproxil fumarate
- Where
- 3 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
HIV/AIDS, Adherence, Medication
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT04870671
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Chronic Hepatitis B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B.
- Trial name
- NCT00117676
- Testing
- TDF, ADV, FTC/TDF
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 382 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR…
- Trial name
- NCT01252940
- Testing
- FTC/RPV/TDF, PI, RTV
- Where
- 111 sites in United States, Austria and 8 more
- Volunteers
- 482 people
- Sponsor
- Gilead Sciences
HIV/AIDS, HIV Prevention
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche.
- Trial name
- NCT04686279
- Testing
- Tenofovir Douche
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Hepatitis B
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
- Trial name
- NCT02496897
- Testing
- FP-02.2 Vaccine, IC31® Adjuvant
- Where
- 21 sites in South Korea, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Altimmune, Inc.
Patient Adherence
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643).
- Trial name
- CCTG595VitD (NCT02367599)
- Testing
- Vitamin D Supplement
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego