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Antiretroviral Agent

Islatravir + Ulonivirine for HIV

Q: What is the aim of this medical research experiment?

This trial, which will be monitored for 48 weeks, is primarily measuring the percentage of participants that discontinue due to adverse effects. Secondary outcomes include Percentage of patients with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1 RNA &#x3C;40 and 50 copies/mL determined by real time PCR assay, as well as differences from baseline in CD4+ T-cell count evaluated at a central laboratory.

Q: What risk factors accompany Islatravir usage?

Our team at Power has assigned Islatravir a score of 2 due to the fact that it is only in Phase 2 trials, and thus there are some reports affirming its safety but none demonstrating efficacy.

Q: In what applications is Islatravir typically employed?

Patients who are naive to antiretroviral therapy and lack resistance to darunavir may be treated with Islatravir.

Q: What is the current size of the participant pool for this experiment?

This clinical trial is now closed to new participants; its first posting was on March 9th 2021, and the last update came on June 13th 2022. <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1 infected individuals may be interested in one of the 107 trials recruiting for this condition, while patients with Islatravir should look into one of the 102 studies currently enrolling.

Q: How many facilities are managing this clinical trial?

This clinical trial is being hosted out of a variety of ten different sites, such as the <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City CARE Clinic ( Site 2703) in <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>, Midway Immunology and Research ( Site 2713) in Fort Pierce, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> and Saint Hope Foundation Inc. (Site 2716) located in Bellaire <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a>

Q: Are there opportunities for recruitment into this experiment currently?

Research hosted on clinicaltrials.gov suggests that this medical trial is not actively recruiting patients at the present moment, given its first posting date of March 9th 2021 and last update from June 13th 2022. Nonetheless, there are currently 209 other trials accepting candidates for participation.

Q: Have researchers conducted other investigations into Islatravir's efficacy?

At the present moment, there are 102 research projects analyzing Islatravir. 23 of these investigations have advanced to Phase 3 trials. Although most experiments centered around Islatravir can be found in Boylston, MA., overall 1734 sites are conducting studies on this medication.

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (bl) and week 144

Awards & highlights

Study Summary

This trial will evaluate the safety of adding islatravir to current HIV medication in adults who have been virologically suppressed for at least six months.

Who is the study for?

Adults over 18 with HIV-1 who've been virologically suppressed for at least 6 months using BIC/FTC/TAF can join. They must have a CD4+ T-cell count >200 cells/mm^3 and an HIV-1 RNA <50 copies/mL. Women can't be pregnant, breastfeeding, or planning to conceive; they must use effective contraception or practice abstinence.Check my eligibility

What is being tested?

The trial is testing the safety of Islatravir (ISL) + Ulonivirine in adults with HIV-1 compared to a placebo. Participants are randomly assigned to receive either the study drugs or placebos while their health data is closely monitored.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system changes, gastrointestinal issues, fatigue, and potential drug-specific adverse events which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (bl) and week 144

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (bl) and week 144

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (bl) and week 144 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants discontinuing study intervention due to AE

Percentage of participants with ≥1 adverse event (AE)

Secondary outcome measures

Change from BL in CD4+ T-cell count

Change from baseline (BL) in cluster of differentiation 4+ (CD4+) T-cell count

Incidence of viral drug resistance

+3 more

Side effects data

From 2022 Phase 2 trial • 242 Patients • NCT04003103

Headache

Nausea

Blood pressure increased

Diarrhoea

Upper respiratory tract infection

Abdominal pain

Accidental overdose

100%

80%

60%

40%

20%

Study treatment Arm

Islatravir 120 mg

Placebo

Islatravir 60 mg

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 3: ISL 20 mg + Ulonivirine 400 mgExperimental Treatment3 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD (Part 1).

Group II: Group 2: ISL 20 mg + Ulonivirine 200 mgExperimental Treatment4 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD (Part 1).

Group III: Group 1: ISL 20 mg + Ulonivirine 100 mgExperimental Treatment4 Interventions

Participants receive ISL 20 mg (Parts 1-3) + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD) [Part 1].

Group IV: Group 4: BIC/FTC/TAFActive Control3 Interventions

Participants receive placebo to ISL + placebo to ulonivirine QW (Part 1) and BIC/FTC/TAF 50 mg/200 mg/25 mg QD (Parts 1 and 2).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ulonivirine

2014

Completed Phase 1

~20

Islatravir

2020

Completed Phase 2

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,667 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,392 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,325 Total Patients Enrolled

Media Library

BIC/FTC/TAF (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04564547 — Phase 2

Frequently Asked Questions

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

What is the aim of this medical research experiment?

"This trial, which will be monitored for 48 weeks, is primarily measuring the percentage of participants that discontinue due to adverse effects. Secondary outcomes include Percentage of patients with HIV-1 RNA <40 and 50 copies/mL determined by real time PCR assay, as well as differences from baseline in CD4+ T-cell count evaluated at a central laboratory."

Answered by AI

What risk factors accompany Islatravir usage?

"Our team at Power has assigned Islatravir a score of 2 due to the fact that it is only in Phase 2 trials, and thus there are some reports affirming its safety but none demonstrating efficacy."

Answered by AI

In what applications is Islatravir typically employed?

"Patients who are naive to antiretroviral therapy and lack resistance to darunavir may be treated with Islatravir."

Answered by AI

What is the current size of the participant pool for this experiment?

"This clinical trial is now closed to new participants; its first posting was on March 9th 2021, and the last update came on June 13th 2022. HIV-1 infected individuals may be interested in one of the 107 trials recruiting for this condition, while patients with Islatravir should look into one of the 102 studies currently enrolling."

Answered by AI

How many facilities are managing this clinical trial?

"This clinical trial is being hosted out of a variety of ten different sites, such as the Kansas City CARE Clinic ( Site 2703) in Missouri, Midway Immunology and Research ( Site 2713) in Fort Pierce, Texas and Saint Hope Foundation Inc. (Site 2716) located in Bellaire Arizona"

Answered by AI

Are there opportunities for recruitment into this experiment currently?

"Research hosted on clinicaltrials.gov suggests that this medical trial is not actively recruiting patients at the present moment, given its first posting date of March 9th 2021 and last update from June 13th 2022. Nonetheless, there are currently 209 other trials accepting candidates for participation."

Answered by AI

Have researchers conducted other investigations into Islatravir's efficacy?

"At the present moment, there are 102 research projects analyzing Islatravir. 23 of these investigations have advanced to Phase 3 trials. Although most experiments centered around Islatravir can be found in Boylston, MA., overall 1734 sites are conducting studies on this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

2021. "Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564547.

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