CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
HPV DNA Plasmids Therapeutic Vaccine VGX-3100 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03603808
NCT03603808Phase 2Completed

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

AIDS Malignancy Consortium·interventional·Posted Jul 27, 2018·Updated May 8, 2026

In Brief

A Phase 2 clinical trial evaluating Electroporation, HPV DNA Plasmids Therapeutic Vaccine VGX-3100, and 1 other intervention for Anal Intraepithelial Neoplasia and 4 related conditions. Completed, enrolled 44 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartSep 21, 2018
Primary CompletionDec 31, 2024
Study CompletionJun 17, 2025
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 7.9 years ago

Interventions

Electroporationdevice

Undergo electroporation

HPV DNA Plasmids Therapeutic Vaccine VGX-3100biological

Given IM

Laboratory Biomarker Analysisother

Correlative studies