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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 baseline (prior to day 1) and up to week 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~baseline (prior to day 1) and up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to day 1) and up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Apparent Terminal Half-life (t1/2) of VH4004280
+13 more

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
VH4004280
2021
Completed Phase 1
~80
VH4011499
2022
Completed Phase 1
~80

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
360 Previous Clinical Trials
468,435 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical study open to those over the age of fifty?

"According to the criteria for entry into this study, participants must be aged 18-55."

Answered by AI

Has the consumption of VH4004280 been authorized by the FDA?

"The safety of VH4004280, which is currently undergoing Phase 1 evaluation, was rated a 1 due to the lack of evidence for its efficacy and limited data regarding its safety."

Answered by AI

Is enrollment in this trial currently available for prospective participants?

"In accordance with the clinicaltrials.gov database, this medical trial is not actively recruiting participants as of now; however, when it was first published on August 22nd 2023 and last updated one day later there were 454 other trials accepting volunteers."

Answered by AI

Who can be admitted into the trial?

"Applicants to this clinical trial must have human immunodeficiency virus and be aged 18-55. In total, 160 individuals will eventually be accepted into the study."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I'm hoping to help in clinical researches to help out medical people who need the information to help patients out there.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
2023. "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012136.
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~107 spots leftby May 2026
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