Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

Completed

• Conditions: HIV Infections

• Registration Number: NCT01311752
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Primary Completion: 2012-11
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 676

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified