Emtricitabine And Tenofovir Disoproxil Fumarate

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

Treatment

2 FDA approvals

20 Active Studies for Emtricitabine And Tenofovir Disoproxil Fumarate

What is Emtricitabine And Tenofovir Disoproxil Fumarate

Emtricitabine

The Generic name of this drug

Treatment Summary

Tenofovir disoproxil fumarate, sold under the brand name Viread, is a medication used to treat HIV and hepatitis B infections. It belongs to a class of drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs) and must usually be taken in conjunction with other antiretroviral drugs. Tenofovir disoproxil was first approved by the FDA in 2001.

Emtriva

is the brand name

image of different drug pills on a surface

Emtricitabine And 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 Emtricitabine And Tenofovir Disoproxil Fumarate Affects Patients

Tenofovir is a drug used to treat HIV-1 and Hepatitis B infections. In lab studies, it has been found to be effective against HIV-1 virus, with an EC50 (50% effective concentration) between 0.04 μM to 8.5 μM. When taken in combination with other drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors), it has been seen to have additive and synergistic effects against HIV-1.

How Emtricitabine And Tenofovir Disoproxil Fumarate works in the body

Tenofovir is a medicine used to treat HIV. It belongs to a group of drugs called nucleotide analog reverse transcriptase inhibitors, which work by blocking a virus-making enzyme in the body. Tenofovir is changed by the body into an active form which stops the virus from making more copies of itself. In rare cases, the virus can become resistant to this medication. This happens when a virus mutation changes how it interacts with the drug.

When to interrupt dosage

The advised dosage of Emtricitabine And Tenofovir Disoproxil Fumarate is contingent upon the perceived condition, including Anti-Retroviral Agents, High Risk Patients and Chronic Hepatitis B. The measure of dosage shifts, in light of the delivery approach (e.g. Tablet or Tablet, film coated) noted in the table underneath.

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

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 - Oral, Tablet, Solution - Oral, Solution

Warnings

Emtricitabine And 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 Emtricitabine And Tenofovir Disoproxil Fumarate.

Common Emtricitabine And 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.

Emtricitabine And Tenofovir Disoproxil Fumarate Toxicity & Overdose Risk

It is not recommended for breastfeeding mothers to take tenofovir disoproxil due to the risk of postnatal transmission of HIV-1. Tenofovir disoproxil has been tested for carcinogenic effects in mice and rats and showed an increased risk of liver adenomas in female mice at higher doses. Pregnancy is categorized as a B drug, and animal studies have revealed no evidence of harm to the fetus, although human studies are limited. There is evidence that tenofovir disoproxil is mutagenic in mouse lymphoma assays and an in vivo mouse micronucleus

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

46 active trials are being conducted to assess the potential of a combination of Emtricitabine and Tenofovir Disoproxil Fumarate to replace the existing antiretroviral therapies for virologically suppressed (HIV1 RNA <50 copies/mL) adult patients, Chronic Hepatitis B and HIV (Human Immunodeficiency Virus).

Condition

Clinical Trials

Trial Phases

HIV

153 Actively Recruiting

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

Sexual Behavior

10 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

40 Actively Recruiting

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

Obesity

0 Actively Recruiting

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

5

Patient Review

10/24/2010

Emtricitabine And Tenofovir Disoproxil Fumarate for HIV

I was already using 3TC and another drug, Tenofovir, so adding Truvada or Emitricitabine/tenofovir 200mg/300 mg had no trouble taking it. I use it in combination with Raltegravir Potassium 400 mg/Isentress 400 mg. However, I started having severe itching all over my body that the antihistamines didn't help relieve. My allergist isn't sure what to do other than stop the HIV drug, but there's nothing to replace it with without causing a reaction.
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Patient Q&A Section about emtricitabine and tenofovir disoproxil fumarate

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

What is the drug emtricitabine used for?

"Emtricitabine is used with other medications to treat human immunodeficiency virus (HIV) infection. Emtricitabine belongs to a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood."

Answered by AI

What is emtricitabine and tenofovir disoproxil fumarate used for?

"This medication is used to treat HIV in adults and children who weigh at least 37 pounds. It is a combination of emtricitabine and tenofovir."

Answered by AI

Is emtricitabine tenofovir used for PrEP?

"Prep drugs can help prevent HIV infection in people who are at risk of becoming infected and don't have HIV. PrEP involves taking a combination drug of emtricitabine-tenofovir (Truvada) or emtricitabine plus tenofovir alafenamide (Descovy) every day."

Answered by AI

What are the side effects of tenofovir and emtricitabine?

"The possible side effects of the medication include nausea, vomiting, stomach pain, diarrhea, headache, dizziness, depression, and joint pain."

Answered by AI

Clinical Trials for Emtricitabine And Tenofovir Disoproxil Fumarate

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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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Behavioral vs Mindfulness Treatments for Insomnia in HIV

50 - 99
All Sexes
Birmingham, AL

The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are: What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT? Participants will: * Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points

Waitlist Available
Has No Placebo

The University of Alabama at Birmingham (+1 Sites)

Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN

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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) (+12 Sites)

Medical Director

Merck Sharp & Dohme LLC

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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

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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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