VGX-3100 + Electroporation for High-Grade Anal Lesions in HIV

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byChia-Ching (Jackie) Wang

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AIDS Malignancy Consortium

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial studies a DNA vaccine called VGX-3100 combined with a technique to help it enter cells, aiming to treat HIV-positive patients with severe anal lesions caused by HPV. The vaccine helps the immune system attack harmful cells, and the technique makes it easier for the vaccine to enter the cells. This combination aims to improve treatment effectiveness for these patients. VGX-3100 is being developed as an alternative to surgery for treating precancerous disease while preserving reproductive health.

Eligibility Criteria

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

I am fully active and can carry on all pre-disease activities without restriction.

My biopsy showed I have high-grade anal lesions.

I tested positive for HPV-16 or -18 from an anal swab.

+13 more

Exclusion Criteria

I have had treatment or removal of high-grade lesions less than 3 months ago.

Received any other investigational agents within the 4 weeks before enrollment, other than investigational antiretroviral agents for HIV and investigational agents for hepatitis C

I haven't taken steroids or immunosuppressants in the last 2 weeks.

+15 more

Participant Groups

The study tests VGX-3100 (an HPV DNA vaccine) combined with electroporation against high-grade anal lesions in HIV-positive patients. Electroporation helps cells absorb the vaccine better, potentially enhancing immune response to kill tumor cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (VGX-3100, electroporation)Experimental Treatment3 Interventions

Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.