Curcumin in Treating HIV Infected and Uninfected Women with High Grade Cervical Squamous Intraepithelial Neoplasia

Summary

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.