HPV-301: REVEAL 1 Trial:A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VGX-3100 DELIVERED INTRAMUSCULARLY FOLLOWED BY ELECTROPORATION WITH CELLECTRA 5PSP FOR THE TREATMENT OF HPV-16 AND/OR HPV-18 RELATED HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION (HSIL) OF THE CERVIX
Study: Drug and Device Combination for Treatment HPV16 and/or HPV18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of Cervix
Sponsor: Inovio Pharmaceuticals, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAR3081
U.S. Govt. ID: NCT03185013
Contact: Reena Vattakalam: 212-342-6895 / rmv2110@cumc.columbia.edu
Additional Study Information: The purpose of this study, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device, CELLECTRA 5PSP, that delivers a small electric charge through 5 needles to increase the amount of the study drug taken up by muscle.
This study is closed
Investigator
Ana Tergas, MD
Do You Qualify?
Have you been diagnosed with a cervical infection with HPV types 16 and/or 18? Yes No
Do you have a history of endocervical curettage (ECC) or adenocarcinoma in situ (AIS)? Yes No
Do you have a history of previous THERAPEUTIC HPV vaccination (livensed prophylactic HPV vaccines are allowed)? Yes No
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For more information, please contact:
Reena Vattakalam
rmv2110@cumc.columbia.edu
212-342-6895
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