Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

Trial Title: Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

NCT ID: NCT06519994

Condition: Human Immunodeficiency Virus
Human Papillomavirus
Cervical Precancer

Conditions: Official terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Uterine Cervical Dysplasia
Artesunate

Conditions: Keywords:
intravaginal
self-administer
artesunate
intravaginal artesunate
vaginal pessaries

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Artesunate vaginal inserts
Description: Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Arm group label: Artesunate vaginal inserts

Intervention type: Drug
Intervention name: Placebo vaginal inserts
Description: Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.
Arm group label: Placebo vaginal inserts

Summary: The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH). The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.

Detailed description: WLWH face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. Cervical cancer is caused by persistent infection with the human papillomavirus (HPV), resulting in precancerous changes that if not adequately treated, progress to cancer. Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries (LMICs). Current treatments for HPV or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in WLWH. In a recent study from Zambia, only 44% of WLWH had cleared HPV at six months following thermal ablation treatment. Other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence.

Criteria for eligibility:
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 - Current pregnancy or breastfeeding status - Current or past history of invasive cervical cancer - History of total hysterectomy - Currently receiving systemic chemotherapy or radiation therapy for another cancer - Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent) - Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin - Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation - Prior chemotherapy within 30 days prior to day 1 of study treatment - Male at birth

Gender: Female

Gender based: Yes

Gender description: Assigned biological female gender at birth.

Minimum age: 25 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

Address:
City: Kisumu
Zip: 614-40100
Country: Kenya

Status: Recruiting

Contact:
Last name: Jackton A Omoto, MBChB

Phone: 254 733617503
Email: jomoto@maseno.ac.ke

Investigator:
Last name: Jackton Omoto, MBChB
Email: Principal Investigator

Start date: July 4, 2024

Completion date: November 30, 2025

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: Kenya Medical Research Institute
Agency class: Other

Collaborator:
Agency: Maseno University School of Medicine, Kenya
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519994
http://unclineberger.org/patientcare/clinical-trials/clinical-trials