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Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

Study of Human Papillomavirus Related Genital Pathology Among HIV Positive

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01311752
Acronym
ANRS CO17
Enrollment
676
Registered
2011-03-09
Start date
2007-11-30
Completion date
2012-12-31
Last updated
2012-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

human papillomavirus, follow up

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.

Interventions

PROCEDUREsurgical 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026