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Antiretroviral Agent

Islatravir + Ulonivirine for HIV

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
Must not have
Is female and expecting to conceive or donate eggs at any time during the study
Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (bl) and week 144

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman and do not plan to get pregnant or donate eggs during the study.
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I have an active hepatitis C or B infection.
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I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.
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My HIV is resistant to certain medications.
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I am currently diagnosed with acute hepatitis.
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I am not on, nor do I need, any immune-weakening drugs.
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I am infected with HIV-2.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants discontinuing study intervention due to AE
Percentage of participants with ≥1 adverse event (AE)
Secondary study objectives
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
10%
Headache
5%
Diarrhoea
5%
Nausea
4%
Upper respiratory tract infection
3%
Abdominal pain
2%
Alanine aminotransferase increased
2%
Dizziness
1%
Blood pressure increased
1%
Intentional self-injury
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Islatravir 60 mg
Islatravir 120 mg
Placebo

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
~440

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,301 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,015 Previous Clinical Trials
5,186,172 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,889 Previous Clinical Trials
8,089,032 Total Patients Enrolled

Media Library

BIC/FTC/TAF (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04564547 — Phase 2
~13 spots leftby Mar 2025
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