Tenofovir Disoproxil Fumarate

Antiretroviral Therapy, HIV test negative, HIV Infections + 12 more

Treatment

2 FDA approvals

20 Active Studies for Tenofovir Disoproxil Fumarate

What is Tenofovir Disoproxil Fumarate

Emtricitabine

The Generic name of this drug

Treatment Summary

Tenofovir disoproxil fumarate, sold under the brand name Viread, is a medicine used to treat HIV and hepatitis B. It works by interfering with the reproduction of the virus in the body. This drug belongs to a family of antiretroviral medications known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). Tenofovir disoproxil was first approved by the FDA in 2001.

Emtriva

is the brand name

image of different drug pills on a surface

Tenofovir Disoproxil Fumarate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Emtriva

Emtricitabine

2003

131

Approved as Treatment by the FDA

Emtricitabine, also called Emtriva, is approved by the FDA for 2 uses including HIV and adults and pediatric patients weighing at least 17 kg .

HIV

Helps manage Human Immunodeficiency Virus Type 1 (HIV-1) Infection

adults and pediatric patients weighing at least 17 kg

Effectiveness

How Tenofovir Disoproxil Fumarate Affects Patients

Tenofovir is a drug used to treat HIV-1 and Hepatitis B infections. In laboratory tests, the drug has been shown to be effective against HIV-1 with a 50% effective concentration (EC50) of 0.04 - 8.5 μM. Tenofovir works by preventing viral DNA chain elongation, which stops the virus from replicating. Tenofovir has also been found to have a synergistic effect when taken with other drugs such as nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors.

How Tenofovir Disoproxil Fumarate works in the body

Tenofovir is an antiretroviral drug, which works by blocking the enzyme that helps HIV-infected individuals replicate their virus. Tenofovir is first converted to its active form, and then to its active metabolite, tenofovir diphosphate, which stops the virus from replicating by blocking its natural deoxyribonucleotide substrate. In rare cases, HIV-1 isolates can develop a decreased susceptibility to tenofovir, due to a mutation known as K65R.

When to interrupt dosage

The prescribed dosage of Tenofovir Disoproxil Fumarate is contingent upon the diagnosed condition, including Anti-Retroviral Agents, High Risk Patients and Chronic Hepatitis B. The amount of dosage fluctuates as per the method of delivery (e.g. Tablet or Tablet, film coated) listed in the table beneath.

Condition

Dosage

Administration

Antiretroviral Therapy

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV test negative

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV Infections

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV Transmission

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Anti-Retroviral Agents

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

HIV

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

adults and pediatric patients weighing at least 17 kg

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

not requiring CYP3A inhibitors

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

treatment failure

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Obesity

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Sexual Behavior

200.0 mg, , 100.0 mg, 133.0 mg, 167.0 mg, 10.0 mg/mL, 120.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Solution, Solution - Oral

Warnings

Tenofovir Disoproxil Fumarate Contraindications

Condition

Risk Level

Notes

HIV

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Emtricitabine may interact with Pulse Frequency

There are 20 known major drug interactions with Tenofovir Disoproxil Fumarate.

Common Tenofovir Disoproxil Fumarate Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The excretion of Abemaciclib can be decreased when combined with Emtricitabine.

Procainamide

Major

The excretion of Procainamide can be decreased when combined with Emtricitabine.

Topotecan

Major

The excretion of Topotecan can be decreased when combined with Emtricitabine.

Cefradine

Minor

The excretion of Cefradine can be decreased when combined with Emtricitabine.

Estrone sulfate

Minor

The excretion of Estrone sulfate can be decreased when combined with Emtricitabine.

Tenofovir Disoproxil Fumarate Toxicity & Overdose Risk

Breastfeeding: HIV-1-infected mothers should not breastfeed their infants to prevent postnatal transmission of HIV-1. If a mother is taking tenofovir disoproxil, she should not breastfeed her infant. Carcinogenesis: Long-term studies in mice and rats have found that tenofovir disoproxil fumarate can increase the risk of liver cancer in mice, but no such risk was found in rats. Pregnancy: Tenofovir disoproxil is classified as a pregnancy Category B drug, meaning it

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Tenofovir Disoproxil Fumarate Novel Uses: Which Conditions Have a Clinical Trial Featuring Tenofovir Disoproxil Fumarate?

Currently, 46 active trials are evaluating the potential of Tenofovir Disoproxil Fumarate to replace current antiretroviral regimens for adult patients with virologically suppressed HIV-1 RNA (<50 copies/mL) at the start of therapy, as well as for the treatment of Chronic Hepatitis B and HIV (Human Immunodeficiency Virus).

Condition

Clinical Trials

Trial Phases

HIV

149 Actively Recruiting

Phase 2, Not Applicable, Phase 1, Phase 3, Phase 4, Early Phase 1

Sexual Behavior

8 Actively Recruiting

Not Applicable, Phase 4

HIV Infections

0 Actively Recruiting

Anti-Retroviral Agents

0 Actively Recruiting

treatment failure

0 Actively Recruiting

adults and pediatric patients weighing at least 17 kg

0 Actively Recruiting

HIV Transmission

0 Actively Recruiting

Obesity

0 Actively Recruiting

Antiretroviral Therapy

0 Actively Recruiting

HIV

0 Actively Recruiting

Obesity

0 Actively Recruiting

not requiring CYP3A inhibitors

0 Actively Recruiting

HIV test negative

0 Actively Recruiting

HIV

38 Actively Recruiting

Phase 2, Phase 3, Phase 1, Early Phase 1, Not Applicable, Phase 4

Obesity

0 Actively Recruiting

Tenofovir Disoproxil Fumarate Reviews: What are patients saying about Tenofovir Disoproxil Fumarate?

5

Patient Review

6/17/2008

Tenofovir Disoproxil Fumarate for HIV

I've been taking this medication in conjunction with other treatments and it's working really well for me. I didn't have any negative side effects, except for some temporary withdrawal symptoms when I first started taking it, but overall it's a great medication that's helped my cells stay undetectable.

4.7

Patient Review

2/1/2012

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I stopped taking this medication for a while and when I started again, I had itchiness all over my body. After taking it for three months though, I feel much better now and the itching has gone away.

4.3

Patient Review

8/30/2013

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've been taking this medication for six months and my viral load is now undetectable. I'm pleased with this outcome, though my doctor wants me to keep taking the drug and getting tested periodically.

4

Patient Review

8/27/2011

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

This treatment has kept my virus load at a chronic level of below 500iu. In fact, it lowered to 50iu after just six months. And as of now, my current viral load is <20ui.

4

Patient Review

4/28/2015

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've gained weight, gotten chronic headaches, and struggled with insomnia since starting this medication, but it has normalized my liver enzymes.

3

Patient Review

6/22/2012

Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

I've been on this medication for five weeks to treat a viral infection. I'm not seeing the results I want yet, but I'm hopeful that with more time it will be effective.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tenofovir disoproxil fumarate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When is the best time to take tenofovir disoproxil fumarate?

"You should take tenofovir tablets with a meal or a snack. (However, if you have been prescribed the combination brand Atripla®, these tablets should be taken when your stomach is empty, which means taking them one hour before any food or waiting until two hours afterwards.)"

Answered by AI

Can tenofovir cure hepatitis B?

"Although Tenofovir cannot cure hepatitis b, it might help to prevent further complications such as cirrhosis of the liver or liver cancer. Additionally, it may prevent the spread of the virus to others. However, there are no generic drugs available for this medication."

Answered by AI

What are the side effects of taking tenofovir?

"The side effects of the medication include diarrhea, headache, depression, rash, itching, fever, difficulty falling asleep or staying asleep, and gas."

Answered by AI

What is tenofovir disoproxil fumarate used for?

"Emtricitabine; Tenofovir Disoproxil Fumarate helps manage HIV infection by limiting the spread of the virus in the body. It can also be used for Prep (pre-exposure prophylaxis) to lower the risk of getting HIV through sex."

Answered by AI

Clinical Trials for Tenofovir Disoproxil Fumarate

Image of Alabama CRS (Site ID: 31788) in Birmingham, United States.

Antibodies for HIV

18 - 55
All Sexes
Birmingham, AL

This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together. Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B). Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits. Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.

Phase 1
Waitlist Available

Alabama CRS (Site ID: 31788) (+5 Sites)

Image of New Jersey Community Research Initiative in Newark, United States.

AI-DBT for Suicide Prevention in HIV/AIDS

18+
All Sexes
Newark, NJ

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Recruiting
Has No Placebo

New Jersey Community Research Initiative (+1 Sites)

Elissa Kozlov, PhD

Image of George Washington University Emergency Department in Washington D.C., United States.

Decision Support Tool for HIV Prevention

18+
All Sexes
Washington D.C., United States

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Phase 1
Waitlist Available

George Washington University Emergency Department (+1 Sites)

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Image of Midway Immunology and Research Center (1503) in Ft. Pierce, United States.

Islatravir + Ulonivirine for HIV

18+
All Sexes
Ft. Pierce, FL

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Phase 2 & 3
Recruiting

Midway Immunology and Research Center (1503) (+19 Sites)

Medical Director

Merck Sharp & Dohme LLC

Image of University of Alabama at Birmingham in Birmingham, United States.

Olfactory Training for HIV

18+
All Sexes
Birmingham, AL

The goal of this study is to examine two types of olfactory interventions (olfactory training vs overnight odor diffuser) in adults with HIV. The two research questions are: 1. Determine if participants find the intervention acceptable and assess feasibility of the study. 2. Determine if the intervention improves olfactory function and cognitive function. Participants will come to our office and be administered the baseline battery of questions including olfactory and cognitive performance tests. Then they will be randomized and sent home with one of the two interventions (below) in which they will engage in it for 8 weeks, after which they come back to our office for the posttest battery of questions including olfactory and cognitive performance test. 1. Olfactory Training at Home -- 4 scents in which they will smell twice a day for 8 weeks. 2. Overnight Diffuser Group -- a single scent diffuser that participants will turn on while they sleep and use for 8 weeks.

Phase < 1
Waitlist Available

University of Alabama at Birmingham

Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

Image of University of North Carolina in Chapel Hill, United States.

MGD020 + MGD014 for HIV

18 - 65
All Sexes
Chapel Hill, NC

This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART). The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help expose HIV in cells to the antibodies. The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are given. In this study, participants will be randomly assigned to one of three groups. All participants receive MGD014 and MGD020, given sequentially as infusions through an IV for 4 doses. Participants in one group (group A) receive only MGD014 and MGD020. Participants in another group (group B) will stop taking their ART therapy for up to 8 weeks (a temporary treatment interruption (TTI)) while receiving MGD014 and MGD020. Participants in the third group (group C) receive Vorinostat in addition to MGD014 and MGD020. Total time of participation is about 8 months and involves 13 or 18 visits, depending on group assignment.

Phase 1
Recruiting

University of North Carolina

Cynthia L. Gay, MD

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CHAMPION Intervention for Pre-exposure Prophylaxis Adherence

18 - 40
Male
San Francisco, CA

The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.

Waitlist Available
Has No Placebo

Center on Substance Use and Health

Glenn-Milo Santos, PhD, MPH

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