Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

An observational study of HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: HIV Infections
What is being tested?: surgical management of high grade lesions
Type of treatment: Surgery or procedure
How many people: 676 participants
Where: No sites listed yet
Study dates: Nov 2007to Dec 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

women > 18 years old
attending outpatient gynecology consultation
HIV positive
with written informed consent
on social security

Who cannot join

unaffiliated to the social healthy security french system

About this study

Official title: 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:

To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
To describe cervical cancers observed in the cohort
To study the evolution of recurrent high-grade lesions after surgery
To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
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 ;
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 ;
To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;

Read the 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.

Conditions: HIV Infections
Being tested: surgical management of high grade lesions
Keywords: human papillomavirus, follow up
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

surgical management of high grade lesionsProcedure or surgery
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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Dec 2012

First posted9 Mar 2011 (estimated)
Study startNov 2007
Primary completionNov 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 676 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01311752
Sponsor's protocol ID: 2007-A00703-50
Acronym: ANRS CO17
Status last verified: Dec 2012
First submitted: 16 Jul 2010
Last updated: 27 Dec 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Human Papillomavirus Related Genital Pathology Among HIV Positive
ClinicalTrials.gov ID: NCT01311752
Acronym / sponsor ID: ANRS CO17 / 2007-A00703-50
Conditions: HIV Infections
Keywords: human papillomavirus, follow up
Study type: Observational
Recruitment status: Completed
Enrolment: 676 participants (actual)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Collaborators: 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., Groupe Hospitalier Pitie-Salpetriere, Surgery study Hervé Foulot Cochin Paris
Study start: Nov 2007
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 9 Mar 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
To describe cervical cancers observed in the cohort
To study the evolution of recurrent high-grade lesions after surgery
To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
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 ;
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 ;
To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
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 design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

women > 18 years old
attending outpatient gynecology consultation
HIV positive
with written informed consent
on social security

Key exclusion criteria (1 listed)

unaffiliated to the social healthy security french system

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
surgical management of high grade lesionsClinical, 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.	Procedure or surgery	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Isabelle Heard, MD principal investigator

Unité biologie de la reproduction, GH Pitié Salpétrière

Manuella Bonmarchand principal investigator

Service Médecine Interne La Pitié Salpétrière

Roland Tubiana principal investigator

Service maladies infectieuses La Pitié Salpétrière

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01311752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2012.