Cancer
Conditions
Interventions
Placebo to Artesunate Pessaries
Artesunate 200mg pessaries
Sponsors
Lineberger Comprehensive Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Age 25 years or older Known HIV seropositive status On antiretroviral therapy for > 90 days prior to enrollment Weight =50 Kg at study entry* Positive HPV screening test and within 4-8 weeks of thermal ablation Ability to provide informed consent Planning to stay within the study locale during the duration of the study (24 weeks) Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study
Exclusion criteria
Exclusion criteria: 1. Current pregnancy or breastfeeding status 2. Current or past history of invasive cervical cancer 3. History of total hysterectomy 4. Currently receiving systemic chemotherapy or radiation therapy for another cancer 5. Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent) 6. Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin 7. Have a medical comorbidity that, in the opinion of the investigator, would interfere with study participation 8. Prior chemotherapy within 30 days prior to day 1 of study treatment 9. Male at birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of type-specific HPV genotype(s) | — |
Secondary
| Measure | Time frame |
|---|---|
| Type, frequency, severity and duration of adverse events (AEs) using NCI CTCAE v5.0 and DAIDS standardized scales.;Adherence | — |
Countries
Kenya
Contacts
Public ContactJackton Omoto
Co Principal Investigator
Outcome results
None listed