Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Clearance of type-specific HPV genotype(s)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo vaginal inserts
Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
干预措施: Placebo vaginal inserts (Drug)
Artesunate vaginal inserts
Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
干预措施: Artesunate vaginal inserts (Drug)
结局指标
主要结局
Clearance of type-specific HPV genotype(s)
时间窗: 24 weeks
The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported.
次要结局
- Acceptability measured by acceptability questionnaire(Week 6)
- Adherence(Week 6)