About this trial
The purpose of this study is to see if curcumin can suppress HPV infection in women with low-grade squamous intraepithelial lesions (LSIL) disease or treated high-grade squamous intraepithelial lesions (HSIL) disease. This study plans to explore the effect of curcumin as a potential medical treatment in HIV-uninfected and infected women with mild precancerous lesions of the cervix or recently treated high-grade precancerous lesions at risk for persistent HPV infection. About 200 women with low-grade precancerous lesions of the cervix or recently treated high-grade precancerous lesions will be enrolled to either insert 2000 mg of curcumin capsules in their vagina once a week or placebo after undergoing colposcopy or loop electrosurgical excision procedure (LEEP). They will have a repeat visit in 6 months where they will undergo a Pap smear and HPV test to determine if there are higher rates of HPV clearance after curcumin administration. If HPV is present or the Pap smear is abnormal, patients will then undergo colposcopic examination to evaluate cervical histology.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Curcumin C3 Complex
- Placebo
Treatment groups
Sponsors and collaborators
Lisa Flowers
Lead sponsor
Emory University
Sponsor institution