Trial record 19 of 34 for:    " June 16, 2010":" July 16, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborators:
Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
Isabelle Cartier Paris
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) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01311752
First received: July 16, 2010
Last updated: December 26, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


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)
Intervention Details:
    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.

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

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

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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
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
Isabelle Cartier Paris
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

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014