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Integrase Inhibitor

VH3810109 + Cabotegravir for HIV (EMBRACE Trial)

Phase 2

Waitlist Available

Research Sponsored by ViiV Healthcare

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 up to month 24

Awards & highlights

EMBRACE Trial Summary

This trial evaluates if a new HIV drug combo is effective in adults already on therapy.

Who is the study for?

Adults living with HIV who have been virologically suppressed on antiretroviral therapy (ART) are eligible for this trial. They must have had stable ART regimens, a CD4+ T-cell count ≥350 cells/mm^3, and weigh between 50-115 kg. Participants cannot be using cabotegravir or fostemsavir currently, nor can they have certain health conditions like cirrhosis or untreated syphilis.Check my eligibility

What is being tested?

The trial is testing the effectiveness of VH3810109 in combination with Cabotegravir against standard HIV treatments. VH3810109 will be administered either intravenously or subcutaneously along with recombinant hyaluronidase (rHuPH20), while Cabotegravir will be given as an intramuscular injection.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, allergic responses to components of the treatment, general discomfort such as fatigue or headaches, and possible interference with liver function. The exact side effects will vary depending on individual tolerance to the medications.

EMBRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants with Plasma HIV-1 Ribonucleic acid (RNA) Greater Than or Equal to (≥)50 Copies per Millilitre (c/mL) per Snapshot Algorithm at Month 6

Secondary outcome measures

Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count

Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count

Change From Baseline in CD4+ T-Cell Count

+15 more

EMBRACE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Participants Receiving VH3810109 Plus rHuPH20 Plus CabotegravirExperimental Treatment3 Interventions

Group II: Participants Receiving VH3810109 Plus CabotegravirExperimental Treatment2 Interventions

Group III: Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VH3810109

2022

Completed Phase 1

~30

Cabotegravir

2017

Completed Phase 1

~20

rHuPH20

2008

Completed Phase 2

~650

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,498 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05996471 — Phase 2

Frequently Asked Questions

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

Who is eligible to enroll in the clinical trial?

"This clinical trial seeks roughly 150 participants aged between 18 and 70, who have been diagnosed with human immunodeficiency virus infection."

Answered by AI

Is this research endeavor actively seeking participants?

"According to clinicaltrials.gov, recruitment for this medical study has concluded as the most recent changes were made on August 9th 2023. Nevertheless, there are still 456 other trials looking for patients at present."

Answered by AI

Does this investigation accommodate individuals aged thirty or older?

"This trial is open to patients aged between 18 and 70. Those under the age of 18 have access to 111 other studies, while those over 65 can select from 337 different trials."

Answered by AI

How many venues is the clinical trial being conducted in?

"Presently, this trial is deploying personnel to 39 medical centres for patient recruitment. Locations include Bakersfield, Los Angeles and Palm Springs as well as 36 other destinations. To reduce the burden of travelling far distances, it may be wise to pick a nearby centre if you choose to partake in the study."

Answered by AI

What is the Food and Drug Administration's stance on administering VH3810109 in combination with cabotegravir?

"Our team at Power gave VH3810109 Plus Cabotegravir a rating of 2 due to there being preliminary clinical evidence in its favour for safety, but none yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

2023. "A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996471.

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