Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women (ANRS CO17)
|ClinicalTrials.gov Identifier: NCT01311752|
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : December 27, 2012
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:
- To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
- To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
- To describe cervical cancers observed in the cohort
- To study the evolution of recurrent high-grade lesions after surgery
- To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
- 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 ;
- 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 ;
- To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
- To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;
|Condition or disease||Intervention/treatment|
|HIV Infections||Procedure: surgical management of high grade lesions|
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.
|Study Type :||Observational|
|Actual Enrollment :||676 participants|
|Official Title:||Study of Human Papillomavirus Related Genital Pathology Among HIV Positive|
|Study Start Date :||November 2007|
|Primary Completion Date :||November 2012|
|Study Completion Date :||December 2012|
Procedure: surgical management of high grade lesions
Clinical, pathological and biological, data at diagnosis and during follow-up will be collected.
Surgical sample will be collected to study human papillomavirus related genital pathology.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311752
|Principal Investigator:||Isabelle Heard, MD||Unité biologie de la reproduction, GH Pitié Salpétrière|
|Principal Investigator:||Manuella Bonmarchand||Service Médecine Interne La Pitié Salpétrière|
|Principal Investigator:||Roland Tubiana||Service maladies infectieuses La Pitié Salpétrière|
|Principal Investigator:||Ana Canestri||Service maladies infectieuses La Pitié Salpétrière|
|Principal Investigator:||Catherine Creen Hebert||Service Gynécologie-obstétrique Louis Mourier|
|Principal Investigator:||Laurent Mandelbrot||Service Gynécologie Louis Mourier|
|Principal Investigator:||Francoise Meier||Service Gynécologie Louis Mourier|
|Principal Investigator:||Elisabeth Foucher||Service Gynécologie Louis Mourier|
|Principal Investigator:||Marie Jeanne Ducassou||Hopital de jour CISIH Marseille|
|Principal Investigator:||Isabelle Poizot Martin||Hôpital de jour CISIH Marseille|
|Principal Investigator:||Bénédicte Lefèvre||Service des maladies infectieuses St Antoine|
|Principal Investigator:||Bruno Carbonne||Service Gynécologie St Antoine|
|Principal Investigator:||Dahlia Torchin||Service Gynécologie St Antoine|
|Principal Investigator:||Anne Isabelle Richet||Service Gynécologie St Antoine|
|Principal Investigator:||Jean Paul Viard||centre de diagnostic et thérapeutique Hopital Hotel Dieu|
|Principal Investigator:||Christine Rousset Jablonski||Service Gynécologie Obstétrique Hopital Hotel Dieu|