Clinical trials: Tenofovir
HIV Infections
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART)…
- Trial name
- TOTEM (NCT00323492)
- Testing
- Truvada, Current HAART regimen
- Where
- France
- Volunteers
- 92 people
- Sponsor
- Gilead Sciences
Hiv
Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide
Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications (one pill daily) to maintain blood and genital drug…
- Trial name
- NCT03350672
- Testing
- FTC/TAF
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Philadelphia Fight
Infection, Human Immunodeficiency Virus
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC)…
- Trial name
- ASSURE (NCT01102972)
- Testing
- Reyataz + Norvir + Truvada, Reyataz + Epzicom
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 297 people
- Sponsor
- ViiV Healthcare
HIV Infection
Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA…
- Trial name
- HEAT (NCT00244712)
- Testing
- emtricitabine/tenofovir, abacavir/lamivudine
- Where
- 74 sites in United States, Puerto Rico
- Volunteers
- 688 people
- Sponsor
- GlaxoSmithKline
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 Infections
Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral…
- Trial name
- NCT00705679
- Testing
- Emtricitabine/tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate, Tenofovir 1% vaginal gel
- Where
- 15 sites in South Africa, Uganda and 1 more
- Volunteers
- 5,029 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus…
- Trial name
- NCT01106586
- Testing
- Stribild, ATV, Ritonavir
- Where
- 146 sites in United States, Australia and 15 more
- Volunteers
- 708 people
- Sponsor
- Gilead Sciences
HBeAg-negative Chronic Hepatitis B
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative 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
- NCT01940341
- Testing
- TAF, TDF
- Where
- 105 sites in United States, Australia and 15 more
- Volunteers
- 426 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus
Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
- Trial name
- NCT02452528
- Testing
- ARC-520, Entecavir, Tenofovir
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- Arrowhead Pharmaceuticals
Infection, Human Immunodeficiency Virus
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
- Trial name
- ING112276 (NCT00951015)
- Testing
- GSK1349572, efavirenz
- Where
- 35 sites in United States, France and 4 more
- Volunteers
- 208 people
- Sponsor
- ViiV Healthcare
HIV-1-infection
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir…
- Trial name
- ARTISTRY-2 (NCT06333808)
- Testing
- Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir, B/F/TAF
- Where
- 104 sites in United States, Argentina and 12 more
- Volunteers
- 577 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, Aging
Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
The goal of this clinical study is to learn about the effect of aging on certain enzymes, or proteins, in the blood and colon. The study involves collection of blood and colon tissue biopsies using a flexible sigmoidoscope or…
- Trial name
- NCT06132386
- Testing
- biopsy
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
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
Hepatitis B
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic…
- Trial name
- HBRN (NCT01369212)
- Testing
- Tenofovir, Peginterferon-alfa 2a and tenofovir
- Where
- 21 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
HIV I Infection
Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF
Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
- Trial name
- DYAD (NCT04585737)
- Testing
- Dolutegravir / Lamivudine Pill, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Charlotte-Paige Rolle, MD
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine…
- Trial name
- NCT02607930
- Testing
- ABC/DTG/3TC, B/F/TAF
- Where
- 121 sites in United States, Belgium and 8 more
- Volunteers
- 631 people
- Sponsor
- Gilead Sciences
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
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