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Monoclonal Antibodies

VH4524184 for HIV

Phase 2
Recruiting
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 65 years of age inclusive at the time of signing the informed consent
Treatment-naïve: No antiretrovirals (ARVs, in combination or monotherapy) received after the diagnosis of HIV-1 infection
Must not have
Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration
Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), day 10
Awards & highlights

Summary

This trial is testing a drug called VH4524184 to see if it is safe and well-tolerated in people with HIV. The drug will be given on its own to see if it can

Who is the study for?
Adults aged 18-65 with HIV-1 who've never had antiretroviral therapy can join this trial. They must be generally healthy, have a certain level of HIV in their blood, and a CD4+ T-cell count above a specific threshold. Women of childbearing potential need negative pregnancy tests. Participants should not have any conditions that might interfere with the study or pose safety risks.
What is being tested?
The trial is testing VH4524184's safety and its ability to lower viral load in treatment-naïve adults with HIV-1 compared to a placebo. The goal is to see if VH4524184 could become part of standard HIV treatment regimens.
What are the potential side effects?
Potential side effects are not detailed here but typically include reactions at the injection site, gastrointestinal issues, headaches, fatigue, and possible allergic reactions among others based on similar treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have not taken any HIV medication since my diagnosis.
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I weigh at least 110 lbs if male, or 99 lbs if female, and my BMI is between 18.5 and 31.
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I have never used INSTI drugs for HIV prevention.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart issues or family history of sudden heart problems, and haven't taken certain immune or HIV drugs in the last 30 days.
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I have a history of major depression or anxiety that needed long-term treatment or hospitalization.
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I am not willing or able to change my current medication for the study.
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My kidney function, measured by creatinine clearance, is below normal.
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I have an untreated syphilis infection.
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I need medications that can affect my heart's electrical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Change from Baseline in logarithm in 10 base (log10) Plasma HIV-1 Ribonucleic Acid (RNA) Through Day 10
Secondary outcome measures
Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts at Day 10
Correlation of VH4524184 PK Parameters with Maximum Plasma HIV-1 RNA change from baseline through Day 10
Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VH4524184Experimental Treatment1 Intervention
Participants will receive VH4524184.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo matching VH4524184.

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Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,779 Total Patients Enrolled
ViiV HealthcareLead Sponsor
369 Previous Clinical Trials
469,554 Total Patients Enrolled
~18 spots leftby Sep 2025
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