Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the use of self-administered artesunate vaginal pessaries as treatment for cervical precancer in low and middle-income countries (LMIC). The central hypothesis of this study is that self-administered intravaginal Artesunate will be safe, and result in a clinical response among both HIV-positive and HIV-negative women with cervical precancer in LMICs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Gilead Sciences
• Treatments: Artesunate

Criteria

Inclusion Criteria:

1. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy

2. Weight ≥50 kg

3. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.

4. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Current pregnancy or breastfeeding status.

2. Current or past history of invasive cervical cancer.

3. History of total hysterectomy.

4. CD4 count less than 200 cells/mm3.

5. Presence of adenocarcinoma in situ on cervical biopsy

6. Currently receiving systemic chemotherapy or radiation therapy for another cancer

7. Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent)

8. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.

9. Prior chemotherapy within 1 month prior to day 1 of study treatment

10. Male at birth