Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women (ANRS CO17)

December 26, 2012 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

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 ;

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom
Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France
Paris, Isabelle Cartier, M.D.
Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris
Surgery study Hervé Foulot Cochin Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabelle Heard, MD, Unité biologie de la reproduction, GH Pitié Salpétrière
  • Principal Investigator: Manuella Bonmarchand, Service Médecine Interne La Pitié Salpétrière
  • Principal Investigator: Roland Tubiana, Service maladies infectieuses La Pitié Salpétrière
  • Principal Investigator: Ana Canestri, Service maladies infectieuses La Pitié Salpétrière
  • Principal Investigator: Catherine Creen Hebert, Service Gynécologie-obstétrique Louis Mourier
  • Principal Investigator: Laurent Mandelbrot, Service Gynécologie Louis Mourier
  • Principal Investigator: Francoise Meier, Service Gynécologie Louis Mourier
  • Principal Investigator: Elisabeth Foucher, Service Gynécologie Louis Mourier
  • Principal Investigator: Marie Jeanne Ducassou, Hôpital de jour CISIH Marseille
  • Principal Investigator: Isabelle Poizot Martin, Hôpital de jour CISIH Marseille
  • Principal Investigator: Bénédicte Lefèvre, Service des maladies infectieuses St Antoine
  • Principal Investigator: Bruno Carbonne, Service Gynécologie St Antoine
  • Principal Investigator: Dahlia Torchin, Service Gynécologie St Antoine
  • Principal Investigator: Anne Isabelle Richet, Service Gynécologie St Antoine
  • Principal Investigator: Jean Paul Viard, centre de diagnostic et thérapeutique Hopital Hotel Dieu
  • Principal Investigator: Christine Rousset Jablonski, Service Gynécologie Obstétrique Hopital Hotel Dieu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-A00703-50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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