Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women
NCT ID: NCT01311752
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
676 participants
OBSERVATIONAL
2007-11-30
2012-12-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* attending outpatient gynecology consultation
* HIV positive
* with written informed consent
* on social security
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
UNKNOWN
Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
UNKNOWN
Paris, Isabelle Cartier, M.D.
INDIV
Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris
UNKNOWN
Surgery study Hervé Foulot Cochin Paris
UNKNOWN
French National Agency for Research on AIDS and Viral Hepatitis
OTHER_GOV
Responsible Party
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Principal Investigators
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Isabelle Heard, MD
Role: PRINCIPAL_INVESTIGATOR
Unité biologie de la reproduction, GH Pitié Salpétrière
Manuella Bonmarchand
Role: PRINCIPAL_INVESTIGATOR
Service Médecine Interne La Pitié Salpétrière
Roland Tubiana
Role: PRINCIPAL_INVESTIGATOR
Service maladies infectieuses La Pitié Salpétrière
Ana Canestri
Role: PRINCIPAL_INVESTIGATOR
Service maladies infectieuses La Pitié Salpétrière
Catherine Creen Hebert
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie-obstétrique Louis Mourier
Laurent Mandelbrot
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie Louis Mourier
Francoise Meier
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie Louis Mourier
Elisabeth Foucher
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie Louis Mourier
Marie Jeanne Ducassou
Role: PRINCIPAL_INVESTIGATOR
Hopital de jour CISIH Marseille
Isabelle Poizot Martin
Role: PRINCIPAL_INVESTIGATOR
Hôpital de jour CISIH Marseille
Bénédicte Lefèvre
Role: PRINCIPAL_INVESTIGATOR
Service des maladies infectieuses St Antoine
Bruno Carbonne
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie St Antoine
Dahlia Torchin
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie St Antoine
Anne Isabelle Richet
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie St Antoine
Jean Paul Viard
Role: PRINCIPAL_INVESTIGATOR
centre de diagnostic et thérapeutique Hopital Hotel Dieu
Christine Rousset Jablonski
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie Obstétrique Hopital Hotel Dieu
Countries
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Related Links
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Related Info
Other Identifiers
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2007-A00703-50
Identifier Type: -
Identifier Source: org_study_id