What side effects are associated with this type of intervention?

Common side effects of integrase inhibitors like Cabotegravir include headache, fatigue, and gastrointestinal issues such as nausea and diarrhea. Recombinant hyaluronidase, used to enhance absorption, can cause local reactions such as redness, swelling, and pain at the injection site. Investigational drugs like VH3810109 may have a range of side effects, but specific data is often limited until more clinical trials are completed. Patients should discuss potential side effects with their healthcare provider to understand the risks and benefits of their treatment options.

What prior FDA approvals exist?

The FDA has approved several integrase inhibitors for the treatment of HIV, including Cabotegravir, which is being studied in combination with VH3810109 and recombinant hyaluronidase. Cabotegravir is an integrase inhibitor that prevents the viral DNA from integrating into the host genome, a crucial step in the HIV replication cycle. Other FDA-approved integrase inhibitors include Elvitegravir and Raltegravir, both of which have shown excellent virological responses and minimal toxicities in clinical trials. These drugs are often part of combination antiretroviral therapies (ART) that are essential for managing HIV infection.

What other types of research exist?

Promising alternatives for HIV treatment in 2024 include long-acting injectable antiretrovirals like lenacapavir, a capsid inhibitor, and islatravir, a nucleoside reverse transcriptase translocation inhibitor. These drugs offer novel mechanisms of action and extended dosing intervals, which can improve adherence and outcomes for patients.

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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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, VH3810109, given with an enzyme to help absorption, combined with cabotegravir shots in adults with controlled HIV who are already on treatment.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cabotegravir

2017

Completed Phase 1

~20

VH3810109

2022

Completed Phase 1

~30

rHuPH20

2019

Completed Phase 2

~780

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV infection include antiretroviral drugs that target different stages of the virus's life cycle. Integrase inhibitors, such as cabotegravir, prevent the viral DNA from integrating into the host cell's genome, which is crucial for viral replication. Recombinant hyaluronidase is used to enhance the absorption of subcutaneously administered drugs, improving their efficacy. Investigational drugs like VH3810109 may work through novel mechanisms to further suppress viral activity. These treatments are vital for maintaining viral suppression, reducing the risk of transmission, and improving the quality of life for HIV patients.

Pharmacokinetic profile of raltegravir, elvitegravir and dolutegravir in plasma and mucosal secretions in rhesus macaques.The failure of HAART to cure the HIV-1/AIDS complex. Suggestions to add integrase inhibitors as complementary virostatics, and to replace their continuous long combination applications by short sequences differing by drug rotations.