Clinical trial NCT01311752: Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women
Official title: Study of Human Papillomavirus Related Genital Pathology Among HIV Positive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: human papillomavirus
follow up
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
name: Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
name: Paris, Isabelle Cartier, M.D.
name: Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris
name: Surgery study Hervé Foulot Cochin Paris
First posted: 2011-03-09
Enrollment: 676
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

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. 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 ;

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unité biologie de la reproduction, GH Pitié Salpétrière
name: Isabelle Heard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Médecine Interne La Pitié Salpétrière
name: Manuella Bonmarchand
role: PRINCIPAL_INVESTIGATOR
affiliation: Service maladies infectieuses La Pitié Salpétrière
name: Roland Tubiana
role: PRINCIPAL_INVESTIGATOR
affiliation: Service maladies infectieuses La Pitié Salpétrière
name: Ana Canestri
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie-obstétrique Louis Mourier
name: Catherine Creen Hebert
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie Louis Mourier
name: Laurent Mandelbrot
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie Louis Mourier
name: Francoise Meier
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie Louis Mourier
name: Elisabeth Foucher
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de jour CISIH Marseille
name: Marie Jeanne Ducassou
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de jour CISIH Marseille
name: Isabelle Poizot Martin
role: PRINCIPAL_INVESTIGATOR
affiliation: Service des maladies infectieuses St Antoine
name: Bénédicte Lefèvre
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie St Antoine
name: Bruno Carbonne
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie St Antoine
name: Dahlia Torchin
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie St Antoine
name: Anne Isabelle Richet
role: PRINCIPAL_INVESTIGATOR
affiliation: centre de diagnostic et thérapeutique Hopital Hotel Dieu
name: Jean Paul Viard
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Gynécologie Obstétrique Hopital Hotel Dieu
name: Christine Rousset Jablonski
role: PRINCIPAL_INVESTIGATOR
References: