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Capsid Inhibitors Safety Study for HIV Prevention

Phase 1
Recruiting
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52

Summary

This trial will test the safety and tolerability of a new drug, given both under the skin and into muscle, in healthy people. It'll also look at how it moves around the body.

Who is the study for?
Healthy adults who can consent, are not at risk of pregnancy, and test negative for SARS-CoV-2. Excluded are those with significant health issues, abnormal blood tests, recent drug trials participation, certain cancer histories or high-risk behaviors for HIV.
What is being tested?
The trial is testing the safety and how the body processes two new capsid inhibitors (VH4011499 & VH4004280) given by injection compared to a placebo in healthy people. It involves single doses administered either under the skin or into a muscle.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to the injections such as pain at the injection site, allergic reactions or systemic effects related to the investigational drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of ISR (Days) AE
Number of Participants with Adverse Events (AEs) as per Severity
Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants Receiving VH4011499Experimental Treatment1 Intervention
Group II: Participants Receiving VH4004280Experimental Treatment1 Intervention
Group III: Participants Receiving PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH4011499
2022
Completed Phase 2
~120
VH4004280
2021
Completed Phase 2
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
375 Previous Clinical Trials
470,622 Total Patients Enrolled
~80 spots leftby May 2026
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