Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

HIV Infections Clinical Trial

— ANRS CO17  

Official title:

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311752
• Other study ID #: 2007-A00703-50
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: December 26, 2012
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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 ;

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

External Links

•   Link