HPV Infection and Cervical Lesions in HIV Infected Women in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 24
- 主要终点
- High grade cervical lesions
研究概览
简要总结
HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical lesion. The study will also provide the distribution of the HPV genotypes involved as well as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is provided according to the National Guidelines.
详细描述
Title of the study: HPV Infection and Cervical Lesions in HIV infected Thai Women - A Prospective Study Country: Thailand Study period: 3 years Planned enrollment duration: 6 months
Primary objectives:
- To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
- To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
- To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone
Secondary objectives:
- To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
- To evaluate cyto-histology performances at different hospital levels Methods: A multicenter prospective cohort study nested in the PHPT cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infected women, older than 18 years of age, followed in the PHPT cohort
排除标准
- •Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial
结局指标
主要结局
High grade cervical lesions
时间窗: Up to 3 years
Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology
High risk HPV infection
时间窗: January 2015
HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68
次要结局
未报告次要终点
研究者
Marc Lallemant
Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement