Clinical Trials

MainTitle

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women (ANRS CO17)

This study has been completed
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
Paris, Isabelle Cartier, M.D.
Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris
Surgery study Hervé Foulot Cochin Paris

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT01311752

First received: July 16, 2010
Last updated: December 26, 2012
Last Verified: December 2012
History of Changes
Purpose

Purpose

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 ;

Condition Intervention
HIV Infections

Procedure : surgical management of high grade lesions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Enrollment: 676
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
  • unaffiliated to the social healthy security french system

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311752

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
Paris, Isabelle Cartier, M.D.
Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris
Surgery study Hervé Foulot Cochin Paris

Investigators

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
More Information

More Information

Additional Information:

Related Info

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT01311752   History of Changes  
Other Study ID Numbers: 2007-A00703-50  
Study First Received: July 16, 2010  
Last Updated: December 26, 2012  

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

human papillomavirus
follow up

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.