5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety of intravaginal 5-FU
研究概览
简要总结
This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV-positive women
- •Age 18 years - 49 years at enrollment
- •Documentation of a biopsy-confirmed CIN2 or CIN3
- •Within 4-12 weeks after primary treatment for CIN2 or CIN3
- •Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age.
- •Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
- •Ability to understand and willingness to sign (or assent when applicable) informed consent
排除标准
- •HIV-negative women
- •Pregnant or planning pregnancy within the next 6 months or breastfeeding
- •Unwilling or unable to use birth control during participation in the study
- •History of invasive cervical cancer
- •Untreated vaginal or vulvar dysplasia
- •Known allergy to 5-Fluorouracil
- •History of total hysterectomy
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
- •Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
研究组 & 干预措施
5-FU Arm
intravaginal 2g 5-fluorouracil cream in every two weeks
干预措施: Intravaginal 5-Fluorouracil (5-FU) (Drug)
结局指标
主要结局
Safety of intravaginal 5-FU
时间窗: Up to 5 months
Safety will be evaluated as type, frequency, and severity of Adverse Events (AE)s. AEs will be evaluated according to the National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Grading Tables. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event and Grade 5 indicates death.
次要结局
- Adherence of intravaginal 5-FU(Up to 5 months)
- Uptake of intravaginal 5-FU(Up to 20 weeks)
- Tolerability of intravaginal 5-FU(Up to 5 months)
- Acceptability of intravaginal 5-FU(Up to 20 weeks)