Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

NCT01311752 | Completed DMC

• 1 other identifier: 2007-A00703-50
• Study Type: observational
• Target: 676
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
2. 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. 3.To describe cervical cancers observed in the cohort
4. 4.To study the evolution of recurrent high-grade lesions after surgery
5. 5.To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
6. 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. 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. 8.To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
9. 9.To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;

Conditions

HIV Infections

Keywords

human papillomavirus; follow up

Interventions

surgical management of high grade lesions PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

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

You may not qualify if:

• unaffiliated to the social healthy security french system

Sponsors & Collaborators

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

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: March 9, 2011
• Study Start: November 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12