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

EmtricitabineThe Generic name of this drug
Treatment SummaryTenofovir 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.
Emtrivais 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 PatientsTenofovir 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 bodyTenofovir 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 - Oral, Tablet, 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 RiskBreastfeeding: 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
156 Actively Recruiting
Phase 2, Phase 1, Phase 3, Not Applicable, 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
39 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?

5Patient 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.
4.7Patient 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.
4.3Patient 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.
4Patient 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.
4Patient 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.
3Patient 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.
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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 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)
Image of The University of Alabama at Birmingham in Birmingham, United States.

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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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
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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 CenterHayoun Lee, PhD
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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 HealthGlenn-Milo Santos, PhD, MPH
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MucoCept-CVN for HIV Prevention

18 - 45
Female
San Francisco, CA
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.
Phase 1
Waitlist Available
UCSF Zuckerberg San Francisco General HospitalCraig Cohen, MD, MPHOsel, Inc.
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N-803 for HIV

18 - 70
All Sexes
San Francisco, CA
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent reservoir and if this could help people control HIV without the need to take regular HIV medicine. This study is testing a drug called N-803. N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and natural killer (NK) cells. CD8+ T cells and NK cells are both crucial for eliminating infected cells. The drug is FDA-approved for the treatment of bladder cancer, but in this study the drug is being used experimentally for HIV.
Phase 2
Waitlist Available
UCSF
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