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
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
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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:
- 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 | 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Human Papillomaviruses
U.S. FDA Resources
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:
Detailed Description:
-
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.
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
--
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:
Related Info 
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 May 21, 2013