Epivir

HIV, Treatment Naive, HIV + 3 more

Treatment

3 FDA approvals

20 Active Studies for Epivir

What is Epivir

Lamivudine

The Generic name of this drug

Treatment Summary

DDC (didanosine) is a medication used to treat HIV-1 and hepatitis B infections. It works by blocking the action of an enzyme called reverse transcriptase, which helps the virus replicate. It is a type of zalcitabine analog, where the 3' carbon in the pentose ring is replaced by a sulfur atom.

Epivir

is the brand name

image of different drug pills on a surface

Epivir Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Epivir

Lamivudine

1995

178

Approved as Treatment by the FDA

Lamivudine, otherwise called Epivir, is approved by the FDA for 3 uses which include HIV and Chronic Hepatitis B Infection .

HIV

Used to treat Human Immunodeficiency Virus Type 1 (HIV-1) Infection in combination with Abacavir

Chronic Hepatitis B Infection

HIV

Effectiveness

How Epivir Affects Patients

Lamivudine is a drug used to treat HIV and hepatitis B. It works by stopping the virus from making copies of itself. When it is activated in the body, lamivudine makes molecules that interfere with the virus’s DNA, making it impossible for it to reproduce. Since lamivudine molecules lack a certain kind of chemical bond, they cannot help the virus create a DNA chain, preventing it from making copies of itself.

How Epivir works in the body

Lamivudine stops viruses from reproducing by preventing them from making copies of their DNA. It works by entering the virus and being changed into an active form. This active form then binds to the virus' DNA and stops it from making more copies.

When to interrupt dosage

The prescribed measure of Epivir is contingent upon the determined condition. The dose fluctuates, according to the technique of delivery featured in the presented table.

Condition

Dosage

Administration

HIV

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

Treatment Naive

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

HIV

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

Anti-Retroviral Agents

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

Chronic Hepatitis B Infection

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

treatment failure

150.0 mg, 100.0 mg, , 5.0 mg/mL, 300.0 mg, 10.0 mg/mL, 30.0 mg

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

Warnings

There are 20 known major drug interactions with Epivir.

Common Epivir Drug Interactions

Drug Name

Risk Level

Description

Aclidinium

Minor

Lamivudine may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Acrivastine

Minor

Lamivudine may decrease the excretion rate of Acrivastine which could result in a higher serum level.

Albutrepenonacog alfa

Minor

Lamivudine may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.

Allylestrenol

Minor

Lamivudine may decrease the excretion rate of Allylestrenol which could result in a higher serum level.

Almasilate

Minor

Lamivudine may decrease the excretion rate of Almasilate which could result in a higher serum level.

Epivir Toxicity & Overdose Risk

Common side effects of taking this drug may include headache, nausea, feeling tired or unwell, nasal problems, diarrhea, and coughing.

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Epivir Novel Uses: Which Conditions Have a Clinical Trial Featuring Epivir?

Currently, 125 active trials are investigating the potential of Epivir in the management of Chronic Hepatitis B.

Condition

Clinical Trials

Trial Phases

HIV

151 Actively Recruiting

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

HIV

40 Actively Recruiting

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

Chronic Hepatitis B Infection

9 Actively Recruiting

Phase 3, Phase 2, Phase 1

Treatment Naive

0 Actively Recruiting

treatment failure

0 Actively Recruiting

Anti-Retroviral Agents

0 Actively Recruiting

Epivir Reviews: What are patients saying about Epivir?

5

Patient Review

12/1/2015

Epivir for HIV

1

Patient Review

9/12/2020

Epivir for HIV

It worked for the first few weeks. But then, the side effects started! Hand and foot cramps, back spasms. No sleep for almost 2 months (cat naps), extreme weight loss 18 lbs in 5 weeks. Vision changes, passing out, breathing problems - finally lactic acidosis. Almost deadly to me; no recovery in sight!!
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Patient Q&A Section about epivir

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

What are the side effects of Epivir?

"You may experience a headache, dizziness, nausea, diarrhea, trouble sleeping, cough, tired feeling, or runny or stuffy nose."

Answered by AI

What is Epivir used to treat?

"Lamivudine is a medication used to treat human immunodeficiency virus (HIV) infection in adults and children 3 months of age and older. Lamivudine is also used to treat hepatitis b infection."

Answered by AI

How much does Epivir cost?

"The retail price for 30, 150MG Tablets of Epivir is $249.22. With a SingleCare Epivir coupon, however, you can get 30, 300MG Tablets of generic Epivir for only $49.17."

Answered by AI

What is the generic name for Epivir?

"This drug is available as a generic drug and a brand-name drug. Lamivudine oral solution is used to treat HIV infection in children.

The oral tablet form of lamivudine is used to treat HIV infection and hepatitis b (HBV) infection. Lamivudine is also available in oral solution form, which is used to treat HIV infection in children. Lamivudine is available as a generic drug or under the brand name Epivir."

Answered by AI

Clinical Trials for Epivir

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

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)

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

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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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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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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 Hospital

Craig Cohen, MD, MPH

Osel, Inc.

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