VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
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
Doctors at several research centers seek patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions to trial a therapeutic DNA vaccine. This vaccine is a loop of selected DNA from the human papilloma virus which is known to cause anal lesions that can become cancerous. The body’s cells uses the genes to produce proteins that prompt the body to attack anal lesions. Additionally, these conditions are eligible:
- Anal Intraepithelial Neoplasia
- High Grade Squamous Intraepithelial Neoplasia
- HIV Positivity
- Human Papillomavirus-16 Positive
- Human Papillomavirus-18 Positive
Study participants will receive intramuscular injections 4 times over 24 weeks, along with a therapy that causes the muscle cells to better absorb the vaccine. Follow up will last up to 48 weeks.
- Be 27 years of age or older
- Not be pregnant or breastfeeding
- Biopsy-proven anal HSIL at screening visit
- At least one focus of HSIL must be large enough to be monitored for response and not completely removed after the screening biopsy
- Must be positive for HPV-16 or -18 on genotyping performed on screening anal swab
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
- Repeat of step (2) at 4 weeks, 12 weeks, and 24 weeks
- A portion of participants will also apply a topical cream 3 times per week for 20 weeks.
- Follow up with lab and physical assessments for up to 48 weeks.
LOCATIONS & CONTACTS:
The study location is at the University of California, San Francisco, CA. (Map)
Contact: Chia-Ching (Jackie) Wang | 415-476-4082 ext 146 | [email protected]
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
University of Arkansas
University of California, Los Angeles
AIDS and Cancer Specimen Resource
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