HP2V-AG: Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.

Sponsor
University Hospital Center of Martinique (Other)
Overall Status
Completed
CT.gov ID
NCT01226368
Collaborator
Fondation de France (Other), Clinique Antilles-Guyane (Other)
455
1
39
11.7

Study Details

Study Description

Brief Summary

Cervical cancer is a public health problem. In term of frequency and mortality, it represents in Martinique the third localization the most frequently diagnosed and the fifth cause of death by cancer. Cervical cancer is recognized as viro-inducted. Human papillomavirus (HPV) is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. It is estimated than about 70 to 80% of women have been or will be infected with an HPV in their genital life, the risks factors being those of the others sexually transmitted diseases (STD). Most of HPV infection are transient, by spontaneous clearance in a few months of the virus under episomal form.

Carcinogen risk is related to viral persistency which inducts the condition of cellular transformation.

Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of the host immunitary response.

HIV infection is known to be associated with an higher prevalency of one or several infection with HPV-HR.

However, no data about HIV/HPV coinfection prevalency are available nowadays in French overseas department of South America whereas they are the most affected by HIV.

Condition or Disease Intervention/Treatment Phase
  • Other: Biological Sample collection

Study Design

Study Type:
Observational
Actual Enrollment :
455 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Mar 1, 2014

Outcome Measures

Primary Outcome Measures

  1. Presence of human papillomavirus [1 day]

    Presence of human papillomavirus in women's cervical smear infected with HIV and followed in West Indies and French Guiana

Secondary Outcome Measures

  1. Characterization of Human papillomavirus genotypes [1 day]

    Characterization of Human papillomavirus genotype found in women's cervical smear infected with HIV and followed in West Indies and French Guiana

  2. Presence and the severity of cervical injuries. [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women aged 18 years old or beyond

  • Infected with HIV1 or HIV2

  • Follow up for HIV infection in one of the center participating in the study and acceptance of the use of Nadis® medical files

  • in one of the center participating in the study and acceptance of the use of Nadis® medical files within the context of follow up that should be realized according to the recommandation of undertaking: systematic Pap smear for asymptomatic patient s (expert's report, Pr.P.Yéni) or Pap smear for classical searching of any pathology of the uterine-cervix.

  • Acceptance of involvement into the study and collection of non opposition to the realization of HPV search from the sample realized for the Pap smear.

Exclusion Criteria:
  • Women under age

  • History of total hysterectomy

  • Patient not followed for HIV infection in one of the center involved in the study

  • Patient that did not accept the use of Nadis® medical files

  • Impossibility to realize a Pap smear

  • Refusal of study's participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Fort-de-France Fort-de-France Martinique 97261

Sponsors and Collaborators

  • University Hospital Center of Martinique
  • Fondation de France
  • Clinique Antilles-Guyane

Investigators

  • Study Director: Sylvie ABEL, MD, University Hospital Center of Martinique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Center of Martinique
ClinicalTrials.gov Identifier:
NCT01226368
Other Study ID Numbers:
  • 10/B/09
First Posted:
Oct 22, 2010
Last Update Posted:
Oct 30, 2014
Last Verified:
Oct 1, 2014
Keywords provided by University Hospital Center of Martinique
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2014