Cancer
Conditions
Interventions
Adjuvant self administered 5FU Cream
Sponsors
UNC OBGYN Department
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. HIV-positive women (confirmed with serum antibody testing) 2. Age 18 years – 49 years at enrollment 3. Documentation of a biopsy-confirmed CIN2 or CIN3 4. Within 4-12 weeks after primary treatment (either cryotherapy, thermal ablation, or loop electrosurgical excision procedure (LEEP)) for CIN2 or CIN3 5. Negative pregnancy test at screening 6. Agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation – plus condoms) during the study duration, if of childbearing age. Condoms can be male or female condoms 7. Ability to understand and willingness to sign (or assent when applicable) informed consent
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable to use birth control during participation in the study 2. History of invasive cervical cancer 3. Known allergy to 5-Fluorouracil 4. History of total hysterectomy 5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient 6. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Uptake, tolerability, acceptability, adherence | — |
Countries
Kenya
Contacts
Public ContactCirilus Ogollah
Coinvestigator
Outcome results
None listed