Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL (NCT03911076) | Clinical Trial Compass
TerminatedPhase 2
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL
Stopped: Slow recruitment/funding
United States16 participantsStarted 2019-05-22
Plain-language 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
Who can participate
Age range25 Years – 70 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female subjects age 25-70 years with confirmation of ASC-US, ASC-H, or LSIL by liquid-based cytology
✓. HIV uninfected
✓. Patients whose cytologic specimen is HPV16+ by Aptima HPV 16 18/45 Genotype Assay
✓. Body Mass Index ≤ 32 kg/m2
✓. Hepatitis B surface antigen negative
✓. Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV positive
✓. Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form, and with anticipated availability for the planned follow-up period of one year
✓. Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.
Exclusion criteria
✕. Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
✕. Patients with immunodeficiency, or treatment with immunosuppressive medications
✕. Administration of any blood product within 3 months of enrollment.
✕. Administration of any licensed vaccine within 2 weeks of enrollment (4weeks for measles vaccine)
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Timeframe: 12 months
2
Percent of patients that have cleared HPV16 at Month 6