AMC-103 Study: A phase 2 evaluation of VGX-3100, a synthetic DNA immunotherapy, targeting human papillomavirus 16 and 18 E6 and E7 proteins, for anal high-grade squamous intraepithelial lesions (HSIL) in HIV-positive individuals

Some people with anal HSIL will develop cancer of the anus. If anal HSIL turns into cancer, the standard treatment is surgery or chemotherapy and radiation. It takes many years for anal HSIL to become cancer. Many anal HSIL will never become cancer at all. Some anal HSIL may go away on its own.

In this study, we will give you a treatment called VGX-3100 to see if it works to get rid of the anal HSIL. This treatment (also called immunotherapy) uses a DNA-based medicine made of small circles of DNA (called DNA plasmids). The DNA plasmids were created in a laboratory to produce a special immune (disease-fighting) response in the body to potentially get rid of anal HSIL.

VGX-3100 is given with an experimental device called CELLECTRA for a procedure called electroporation. Electroporation is a short electrical pulse that allows pores in your body’s cells to absorb the DNA plasmid. Once inside the cell, the DNA plasmids cause the cell to produce the specially designed antigens. These new antigens cause your immune system to potentially get rid of anal HSIL. VGX-3100 and electroporation is experimental when used to treat anal HSIL, because it is not yet a licensed medicine. It also has not been tried in people with HIV. This study is being supported by the National Cancer Institute, AIDS Malignancy Consortium, and Inovio Pharmaceuticals.

All study volunteers will get the same VGX-3100. To be in the study, you need to be 18 years of age or older, HIV-positive, and have never had cancer of the anus, vulva, vagina, or cervix.

Study eligibility & contact

For details about the study please contact 415-583-2277.