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

NCT03603808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-08

Study results available
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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.

Conditions

  • Anal Intraepithelial Neoplasia
  • High Grade Squamous Intraepithelial Neoplasia
  • HIV Positivity
  • Human Papillomavirus-16 Positive
  • Human Papillomavirus-18 Positive

Interventions

DEVICE

Electroporation

Undergo electroporation

BIOLOGICAL

HPV DNA Plasmids Therapeutic Vaccine VGX-3100

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Chia-Ching (Jackie) Wang · AIDS Malignancy Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2024-12-31
Completion
2025-06-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603808 on ClinicalTrials.gov