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VGX-3100 + Electroporation for High-Grade Anal Lesions in HIV
Study Summary
This trial is studying the use of a human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine (VGX-3100) and electroporation to treat patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am fully active and can carry on all pre-disease activities without restriction.I have had treatment or removal of high-grade lesions less than 3 months ago.I haven't taken steroids or immunosuppressants in the last 2 weeks.I have a history of cancer in the anal, penile, vulvar, vaginal, or cervical area.I am currently on treatments that may affect my bone marrow.I do not have any health issues that could make the study unsafe for me.I do not have any severe illnesses that could stop me from following the study's requirements.My biopsy showed I have high-grade anal lesions.I tested positive for HPV-16 or -18 from an anal swab.I am on a working antiretroviral therapy for HIV.I have a serious heart condition that could be life-threatening.I do not have a bleeding or clotting disorder that prevents me from getting IM injections.I have been seizure-free for 5 years or more with little to no seizure medication.I have fewer than two good spots for an IM injection.I am a woman who can have children and have a negative pregnancy test within 3 days before starting VGX-3100.I have many warts that make it hard to see if I have high-grade skin lesions.I have metal implants, devices, tattoos, keloids, or skin issues near my treatment area.I am still experiencing side effects from my previous HSIL treatment.I am a woman and my recent cervical exam showed no signs of cancer.
- Group 1: Treatment (VGX-3100, electroporation)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many medical facilities are participating in this research project?
"The 6 available trial sites include the Anal Dysplasia Clinic MidWest in Chicago, Cornell Clinical Trials Unit in New york, and Boston Medical Centerin Boston; three more are scattered across the continent."
How many participants are being accepted into this research program?
"This clinical trial requires 80 participants that qualify for its criteria to be recruited. Individuals hoping to join have the option of signing up at Anal Dysplasia Clinic MidWest in Chicago, IL or Cornell Clinical Trials Unit in New york, NY."
What risks are associated with the Electroporation procedure?
"Taking into consideration the Phase 2 trial data, our team at Power rates Electroporation's safety as a score of two. While there is evidence suggesting its safety, no clinical research has been conducted to assess efficacy."
Is this trial a pioneering endeavor?
"Presently, two Electroporation trials are underway at 6 various locations across 2 countries. This technology was first tested back in 2018 by Inovio Pharmaceuticals with 80 participants; it succeeded the Phase 2 trial and has since been employed in 581 experiments."
Are there any vacancies remaining in this clinical trial?
"Affirmative. Data found on clinicaltrials.gov demonstrate that this medical experiment, which was launched on September 21st 2018, is actively recruiting volunteers. Eighty participants are needed from 6 different healthcare centres."
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