Curcumin in Treating HIV Infected and Uninfected Women with High Grade Cervical Squamous Intraepithelial Neoplasia
21 Years and older, Female
EU2971-15 (primary)
NCI-2016-01405
IRB00079183
Summary
This randomized phase II trial studies how well curcumin works in treating human immunodeficiency virus (HIV) infected and uninfected women with high grade cervical squamous intraepithelial neoplasia. Natural or herbal treatments, such as curcumin, may help slow down destroy, or prevent the growth of precancerous cells.
Objectives
PRIMARY OBJECTIVE:
I. Determine the association between intravaginal curcumin on known human papilloma virus (HPV)-related molecular target HPV E6/E7 messenger ribonucleic acid (mRNA) expression within high grade squamous intraepithelial lesion (HSIL) lesions of the cervix in HIV uninfected and infected women.
SECONDARY OBJECTIVE:
I. To quantify levels of curcumin in the cervix of women in the curcumin treatment arm.
EXPLORATORY OBJECTIVE:
I. To determine the association between curcumin and other known biomarkers of cervical disease and its effect on the vaginal microbiome.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 4 capsules of curcumin inserted intra-vaginally daily at bedtime for 12 weeks (excluding the time when they are menstruating). Patients undergo a pelvic exam with vaginal sampling and colposcopy with targeted cervical biopsies at weeks 4, 8 and 12. Patients undergo standard of care loop electrosurgical excision procedure (LEEP) at week 16.
ARM II: Patients receive 4 capsules of placebo inserted intra-vaginally daily at bedtime for 12 weeks (excluding the time when they are menstruating). Patients undergo a pelvic exam with vaginal sampling and colposcopy with targeted cervical biopsies at weeks 4, 8 and 12. Patients undergo standard of care LEEP at week 16.
Eligibility
- Age 21 years and older
- HIV uninfected and infected women (without acquired immunodeficiency syndrome [AIDS] defining illness)
- HSIL cytology with no invasive features identified on colposcopy or the baseline biopsy
- Compliant on combined anti-retrovirals (cART) if HIV infected
- On continuous antiretrovials with CD4 count > 200 cells/ml with sustained undetectable viral load for at least months. (HIV positive women)
- Patient on reliable (OCP, LARC, BTL or Depo Provera) birth control: Combined oral contraceptive pill (OCP). Long lasting reversible contraceptive (LARCP), bilateral tubal ligation (BLT) and DepoProvera shot/birth control shot
- Patient willing to conform to the study requirements
- No risk factors for microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
Treatment Sites in Georgia
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