VGX-3100 + Electroporation for High-Grade Anal Lesions in HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to treat high-grade anal lesions in individuals living with HIV. It combines a DNA-based vaccine, VGX-3100, with electroporation, a technique that enhances vaccine absorption. The goal is to boost the immune system's ability to combat these lesions, which can be precursors to cancer. Individuals who are HIV positive, have specific high-grade anal lesions, and are on effective antiretroviral therapy might be eligible to participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on an effective HIV treatment regimen. Some medications, like certain steroids or blood thinners, may need to be adjusted or stopped before participating.
Is there any evidence suggesting that VGX-3100 and electroporation are likely to be safe?
Research has shown that VGX-3100, when used with electroporation, has been safe in past studies. One study found that VGX-3100 was well-tolerated and effective for treating HPV-related anal lesions, with no serious side effects directly linked to the treatment. Some patients experienced mild side effects, such as soreness at the injection site, but these were temporary.
VGX-3100 has also been tested for other conditions, like cervical lesions, and demonstrated similar safety results. This supports its potential safety for treating high-grade anal lesions in this trial. It is important to consult a healthcare provider to understand the possible risks and benefits before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about VGX-3100 for high-grade anal lesions in people with HIV because it uses a unique approach to tackle the problem. Unlike traditional treatments that might rely on surgical removal or topical therapies, VGX-3100 is a therapeutic vaccine made from HPV DNA plasmids. This means it works by training the body's immune system to fight off the HPV virus, which is responsible for these lesions. Additionally, the treatment is delivered using electroporation, a method that enhances the uptake of the vaccine by briefly opening cell membranes, potentially making it more effective. This innovative combination of a DNA-based vaccine and advanced delivery method offers a promising new direction for treating these challenging lesions.
What evidence suggests that VGX-3100 and electroporation might be effective for high-grade anal lesions in HIV?
Research shows that VGX-3100, used with electroporation (a technique that enhances cellular absorption of the treatment), has promising results. In earlier studies, this combination cleared HPV-16/18-related precancerous anal lesions in 50% of patients six months after treatment. In this trial, participants will receive VGX-3100, a DNA vaccine that aims to strengthen the immune system to fight HPV-related lesions, along with electroporation. This method helps the body find and remove abnormal cells caused by the virus. Electroporation enhances the treatment by improving cellular uptake of the vaccine. These findings strongly suggest it could effectively treat high-grade anal lesions in people with HIV.13456
Who Is on the Research Team?
Chia-Ching (Jackie) Wang
Principal Investigator
AIDS Malignancy Consortium
Are You a Good Fit for This Trial?
This trial is for HIV-positive individuals with high-grade anal lesions caused by HPV-16 or -18, who have a life expectancy over 5 years and are on effective antiretroviral therapy. They must have certain blood cell counts within normal ranges and be willing to use contraception. People with recent HSIL treatment, allergies to similar drugs, metal implants near the electroporation site, uncontrolled illnesses, or those on certain medications can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HPV DNA plasmids therapeutic vaccine VGX-3100 intramuscularly and undergo electroporation for 4 doses in weeks 0, 4, 12, and 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall response rate and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Electroporation
- VGX-3100
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
University of Arkansas
Collaborator
University of California, Los Angeles
Collaborator
AIDS and Cancer Specimen Resource
Collaborator
National Cancer Institute (NCI)
Collaborator
Inovio Pharmaceuticals
Industry Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University