Skip to main content
OpenTrials
Completed

NCT Number: NCT01311752

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

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 ;

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
  • Groupe Hospitalier Pitie-Salpetriere
  • Paris, Isabelle Cartier, M.D.
  • Surgery study Hervé Foulot Cochin Paris
  • Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom

Registry information

Official study title

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

Acronym: ANRS CO17

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2011
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.