Delstrigo

HIV, Treatment Naive, HIV + 3 more

Treatment

3 FDA approvals

20 Active Studies for Delstrigo

What is Delstrigo

Lamivudine

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. It belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), and is meant to be taken in combination with other medications. Tenofovir disoproxil was approved by the FDA in 2001.

Epivir

is the brand name

image of different drug pills on a surface

Delstrigo 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 Delstrigo Affects Patients

Tenofovir is used to treat HIV-1 and Hepatitis B infections by preventing the virus from making copies of itself. Laboratory tests have shown that it is effective against HIV-1 at concentrations between 0.04 μM to 8.5 μM. Tenofovir has been found to work well in combination with other drugs used to treat HIV-1, such as nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors, as well as protease inhibitors. Clinical studies have also confirmed that it can effectively fight HIV-1 in cell cultures.

How Delstrigo works in the body

Tenofovir is an antiretroviral medicine used to reduce the amount of HIV in the body. It works by blocking a special enzyme that HIV needs to reproduce. When this enzyme is blocked, the virus can't make as many copies of itself. Tenofovir is absorbed and converted to its active form which is a type of chemical called a nucleotide analog. This chemical then binds to the HIV enzyme and stops it from working. It also prevents the virus from making DNA. In some cases, HIV can become resistant to tenofovir, meaning that it is not as effective at stopping the virus from reproducing

When to interrupt dosage

The suggested dosage of Delstrigo is based on the identified affliction, including Anti-Retroviral Agents, High Risk Patients and Chronic Hepatitis B. The measure of dosage fluctuates, depending on the procedure of delivery (e.g. Tablet or Tablet, film coated) provided in the table below.

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

Warnings

There are 20 known major drug interactions with Delstrigo.

Common Delstrigo 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.

Delstrigo Toxicity & Overdose Risk

When it comes to breastfeeding, the Centers for Disease Control and Prevention recommend that mothers with HIV-1 not breastfeed their infants to prevent transmission. Mothers should not breastfeed if they are taking tenofovir disoproxil. There have been no studies done on pregnant women taking tenofovir disoproxil, but studies done on rats and rabbits showed no signs of harm to the fetus at doses up to 14 and 19 times the recommended human dose. To monitor the effects of this drug on pregnant women, a registry has been created for healthcare providers to register patients. Tenofov

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

Currently, 46 active clinical trials are assessing the potential of Delstrigo to replace a current antiretroviral treatment regimen for certain virologically suppressed (HIV1 RNA <50 copies/mL) adult patients on a stable regimen at the start of therapy, as well as in treating 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

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

Delstrigo Reviews: What are patients saying about Delstrigo?

2

Patient Review

6/25/2021

Delstrigo for HIV

I gained weight when I switched to delstrigo, and my hiv 1rna levels increased.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about delstrigo

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

What are the side effects of Delstrigo?

"The most common side effects of Delstrigo include abnormal dreams, difficulty sleeping, nightmares, depression, headaches, dizziness, drowsiness, coughing, an irritated or runny nose, nausea, diarrhea, abdominal pain, vomiting, hair loss, rashes, muscle disorders, fatigue, and fever."

Answered by AI

What does Delstrigo do?

"The DELSTRIGO prescription medication is used to treat HIV-1 infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines. This decision is made by the patient's healthcare provider after determining that the patient meets certain requirements."

Answered by AI

Who manufactures Delstrigo?

"The European Commission red lighted Merck's DELSTRIGO (doravirine / lamivudine / tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and PIFELTRO (doravirine), an NNRTI, both for the treatment of HIV-1 in [the European Union]."

Answered by AI

How good is Delstrigo?

"In a study of 728 adults, 84% of those treated with Delstrigo had undetectable HIV levels in their blood (fewer than 40 copies/ml) after 48 weeks, compared to 80% of those given a combination of efavirenz, emtricitabine, and tenofovir disoproxil."

Answered by AI

Clinical Trials for Delstrigo

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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

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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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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 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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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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We made a collection of clinical trials featuring Delstrigo, we think they might fit your search criteria.
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