Curcumin for the Treatment of Patients with Cervical Intraepithelial Neoplasia
- HIV-uninfected and infected women (without current acquired immunodeficiency syndrome [AIDS]-defining illness)
- Presence of a cervix
- Biopsy-proven low-grade squamous intraepithelial lesion (LSIL) disease or recently treated high-grade squamous intraepithelial lesion (HSIL) disease
- Adherence to combined anti-retrovirals (cART) if HIV infected
- On continuous antiretrovirals with a CD4 count > 200 cells/ml with sustained undetectable viral load for at least 3 months (only for HIV-positive participants)
- On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot)
- Willing to conform to the study requirements
- Reliable follow-up and contact information
- No risk factors for HSIL or microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
- For women with HSIL only, loop electrosurgical excision procedure (LEEP) completed within 6 weeks preceding initial encounter with study staff and adequate wound healing
- Untreated HSIL or invasive features on colposcopy and the biopsy specimen
- Not adherent to anti-retroviral therapy (cART) (HIV infected participants)
- CD4 count =< 200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)
- Lactating and pregnant people
- Patient with irregular cycles (more than once a month)
- Not on reliable birth control
- Previous hysterectomy
- Prior diagnosis of cervical cancer, treated or untreated
- Inability to provide informed consent
- Medical condition that interferes with the conduct of the study in the investigator’s opinion
- Evidence of active cervical infection or serious cervical disease necessitating surgery
- Known bleeding diathesis
I. To determine if intravaginal curcumin will have higher rates of HPV clearance at 6 months compared to placebo in human immunodeficiency virus (HIV)-uninfected and infected women.
I. To determine if intra-vaginal curcumin administered once weekly for twenty weeks will be safe, acceptable and well-tolerated among women with and without HIV.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive curcumin intravaginally once a week (QW) for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.
ARM II: Patients receive placebo curcumin intravaginally QW for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.
After the completion of study treatment, patients are followed up to 6 months.
Trial Phase Phase II
Trial Type Treatment
Children's Healthcare of Atlanta - Egleston
- Primary ID GRADY4943-20
- Secondary IDs NCI-2020-01951
- Clinicaltrials.gov ID NCT04266275