VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (NCT03603808) | Clinical Trial Compass
CompletedPhase 2
VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
United States44 participantsStarted 2018-09-21
Plain-language summary
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy-proven intra-anal or per-HSIL at baseline (anal intraepithelial neoplasia \[AIN\]2 with a positive p16 stain, PAIN2-3, AIN2-3, or PAIN3/AIN3)
* At least one focus of HSIL must be large enough to be monitored for response, i.e., not completely removed after the screening biopsy
* Must be positive for HPV-16 or -18 on genotyping performed on screening anal swab
* HIV positive; documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care provider
* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay; NOTE: A ?licensed? assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies
* Must be documented to be on an effective combination antiretroviral therapy (ART) regimen, generally a 3-drug regimen based on Department of Health and Human Services (DHHS) treatment guidelines by a licensed health care provider; documentation may be a record of an ART prescription in the participant?s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant?s name; each component agent of a multi-class combination ART regimen will be counted toward the 3-…