LCCC 2236 Study

LCCC 2236: Phase I study of self-administered Artesunate pessaries (vaginal inserts) for treatment of cervical precancer in HIV positive and HIV-negative women in Kenya

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202312740571041

Enrollment

Registered

2023-12-14

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Artesunate 200mg Vaginal Suppository

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy 3. Weight =50 Kg at study entry 4. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age 5. Ability and willingness to provide informed consent

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. CD4 count 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 11. Current use of efavirenz antiretroviral therapy

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
1. Adherence. 2. Change in lesion size. 3. Histologic regression to CIN1 or less. 4. Acceptability	—

Countries

Kenya

Contacts

Public ContactCirilus Ogolla

Site Coordinator

cogollah@kemri-rctp.org+254710183933

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026