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

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

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 ;

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Procedure: surgical management of high grade lesions

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.

• Study Type: Observational
• Enrollment (Actual): 676

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• 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; 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, Hôpital 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 27, 2012
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: human papillomavirus; follow up
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: 2007-A00703-50