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

This study has been completed.
Sponsor:
Collaborators:
Fondation de France
Clinique Antilles-Guyane
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01226368
First received: October 21, 2010
Last updated: October 29, 2014
Last verified: October 2014

October 21, 2010
October 29, 2014
December 2010
January 2011   (final data collection date for primary outcome measure)
Presence of human papillomavirus [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Presence of human papillomavirus in women's cervical smear infected with HIV and followed in West Indies and French Guiana
Same as current
Complete list of historical versions of study NCT01226368 on ClinicalTrials.gov Archive Site
  • Characterization of Human papillomavirus genotypes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Characterization of Human papillomavirus genotype found in women's cervical smear infected with HIV and followed in West Indies and French Guiana
  • Presence and the severity of cervical injuries. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

cervix cells

Non-Probability Sample

Adult HIV-Infected women followed in one of the center participating in the study and who has accepted the use of Nadis® medical files.

  • 1- Women
  • 2- HIV Infection
  • 3- Followed in West Indies and French Guiana for His Infection
  • 4- Acceptance of the Use of Nadis® Medical Files
Other: Biological Sample collection
Cervix cells
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
455
March 2014
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Martinique
 
NCT01226368
10/B/09
No
Centre Hospitalier Universitaire de Fort-de-France
Centre Hospitalier Universitaire de Fort-de-France
  • Fondation de France
  • Clinique Antilles-Guyane
Study Director: Sylvie ABEL, MD Centre Hospitalier Universitaire de Fort-de-France
Centre Hospitalier Universitaire de Fort-de-France
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP