Clinical trial NCT06519994: Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
Official title: Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
Human Papillomavirus
Cervical Precancer
Keywords: intravaginal
self-administer
artesunate
intravaginal artesunate
vaginal pessaries
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Kenya Medical Research Institute
name: Maseno University School of Medicine, Kenya
First posted: 2024-07-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Clearance of type-specific HPV genotype(s)
timeFrame: 24 weeks
Secondary outcomes:
measure: Adherence
timeFrame: Week 6
measure: Acceptability measured by acceptability questionnaire
timeFrame: Week 6
Other outcomes:
measure: Uptake
timeFrame: Baseline
measure: Accrual rate
timeFrame: 24 weeks
measure: Retention rate
timeFrame: 24 weeks
Locations:
city: Kisumu
country: Kenya
facility: Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Chemtai Mungo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: