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临床试验/NCT01311752
NCT01311752已完成不适用

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

French National Agency for Research on AIDS and Viral Hepatitis0 个研究点目标入组 676 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
676

研究概览

简要总结

This study is a Multicentre cohort study with inclusion throughout the full duration of the study.

The primary objective is the study of human papillomavirus related genital pathology in HIV positive women.

The secondary objective are:

  1. To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
  2. To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
  3. To describe cervical cancers observed in the cohort
  4. To study the evolution of recurrent high-grade lesions after surgery
  5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
  6. To describe the specific aspects of surgery for the treatment of cervical lesions according to the specific localization in the endocervix in HIV-positive women ;
  7. To study the in situ T cell HPV specific response in cervical lesions and the relationship between virological and clinical parameters, host immune status and natural history of lesions ;
  8. To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
  9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;

详细描述

Data were be collected into evaluate:

  • Analysis of prognostic factors (CD4, antiviral therapy) of cervical lesions, using Cox models.
  • Estimation of rates of Incidence of high grade lesions, of recurrence after surgical treatments using Kaplan Meier tests.
  • Logistic regression analysis for the study of factors associated with complete excision after surgical treatment.
  • SIR (standardised incidence rate) evaluation for cervical cancer

Study procedures are Annual follow-up in case of normal Pap smear, biannual follow-up in case of cervical lesions. Surgical management of High grade lesions.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women > 18 years old
  • attending outpatient gynecology consultation
  • HIV positive
  • with written informed consent
  • on social security

排除标准

  • unaffiliated to the social healthy security french system

研究者

发起方
French National Agency for Research on AIDS and Viral Hepatitis
申办方类型
Other Gov
责任方
Sponsor

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