VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions

Exclusion Criteria

• •Treatment or removal of HSIL less than 3 months prior to enrollment.
• •Patients who received any other investigational agents within the 4 weeks before enrollment, other than investigational antiretroviral agents for HIV and investigational agents for hepatitis C
• •Participants should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration; inhaled steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; participants are permitted to use ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if \>= 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted; use of anabolic steroids is permitted; topical steroids are permitted as long as they are not directly applied to the area of the skin where electroporation is planned
• •History of anal cancer, penile, vulvar, vaginal, or cervical cancer, or signs of any of these malignancies at baseline; participants with prior carcinoma in situ will not be considered to have prior cancer for eligibility purposes
• •Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to VGX-3100
• •Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements or could be negatively affected by the electroporation treatment
• •Presence of unstable or life-threatening cardiac disease (e.g. unstable angina, class 3 or higher congestive heart failure)
• •Presence of acute or chronic bleeding or clotting disorder that would be a contraindication to IM injections (which may include the use blood thinners such as anticoagulants or antiplatelets drugs within two weeks of enrollment). Exception: Over-the-counter aspirin or non-steroidal anti-inflammatory drugs is allowed.
• •Participants who have not recovered from adverse events due to prior anti-HSIL therapy (i.e., have residual toxicity \> grade 1), per Common Toxicity Criteria for Adverse Events (CTCAE) v4.0
• •Participants who have any metal implants, implanted medical devices, tattoos, keloids or hypertrophic scars, or active lesions/rashes within 2 cm of all intended potential sites of treatment/electroporation
• •History of seizures, except if participants have been seizure-free for 5 years or more with the use of one or fewer anti-epileptic agents
• •Sustained, manually confirmed, sitting systolic blood pressure \> 150 mm Hg or \< 90 mm Hg or a diastolic blood pressure \> 95 mm Hg at screening or day 0
• •Resting heart rate \< 50 beats per minute (bpm) (unless attributable to athletic conditioning) or \> 100 bpm at screening or day 0
• •Participants who have less than two acceptable sites available for IM injection considering the deltoid and anterolateral quadriceps muscles
• •Participants who have cardioverter-defibrillator or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist)
• •Participants who are breastfeeding a child; investigational product should not be administered to nursing mothers
• •Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint