Spots Global Cancer Trial Database for Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL
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Trial Identification
Brief Title: Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL
Official Title: A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)
Study ID: NCT03911076
Study Description
Brief Summary: * To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen * To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6
Detailed Description:
Keywords
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Health Awareness, Inc., Port Saint Lucie, Florida, United States
University Hospital, Rutgers New Jersey Medical School, Newark, New Jersey, United States
Obstetrics & Gynecology Associates, Inc., Fairfield, Ohio, United States
Austin Area Obstetrics, Gynecology, and Fertility, Austin, Texas, United States
Corpus Christi Women's Clinic (Elligo Health Research, Inc.), Corpus Christi, Texas, United States
MacArthur Medical Center, Irving, Texas, United States
Contact Details
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