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

Trial Status: Active

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.

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Invasive features on colposcopy and the biopsy specimen
  • Not compliant with anti-retroviral therapy (cART) (HIV infected participants)
  • CD4 count < 200 cells/ml and detectable viral load within the least 3 months (HIV infected participants
  • Lactating and pregnant women
  • Patient with irregular cycles (more than once a month)
  • Patient not on reliable birth control
  • Previous hysterectomy and/or prior treatment for cervical precancer condition

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Lisa C. Flowers
Phone: 404-778-1380
Grady Health System
Status: ACTIVE
Contact: Lisa C. Flowers
Phone: 404-778-1380

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Lisa C. Flowers

  • Primary ID EU2971-15
  • Secondary IDs NCI-2016-01405, IRB00079183
  • Clinicaltrials.gov ID NCT02944578