Topical Curcumin for HPV Related Cervical Disease

Launched by LISA FLOWERS · Feb 11, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether curcumin, a compound found in turmeric, can help eliminate HPV infections in women with certain mild cervical changes called low-grade squamous intraepithelial lesions (LSIL) or those who have recently been treated for more serious changes known as high-grade squamous intraepithelial lesions (HSIL). The study will involve about 200 women who will either use curcumin capsules or a placebo (a non-active treatment) inserted into the vagina once a week for six months. After this period, participants will have follow-up tests, including a Pap smear and an HPV test, to see if curcumin helps clear the virus more effectively.

To be eligible for this study, participants must be women who are either HIV-negative or HIV-positive and not currently experiencing AIDS. They should have a cervix and need to have a confirmed diagnosis of LSIL or recently treated HSIL. Women must also be on reliable birth control and willing to follow the study's requirements. Participants can expect regular check-ins and tests to monitor their health throughout the trial. It’s essential that women with more severe cervical issues or those who are pregnant or breastfeeding do not participate in this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • HIV-uninfected and infected women (without current AIDS-defining illness)
• • Presence of a cervix
• • Biopsy-proven LSIL disease or recently treated HSIL disease
• • Adherence to combined anti-retrovirals (cART) if HIV infected
• • On continuous antiretrovirals with a cluster of differentiation 4 (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, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing
• Exclusion Criteria:
• • 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