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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Fondation de France
Centre d'Investigation Clinique-Epidémiologie Clinique Antilles Guyane
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01226368
First received: October 21, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

cervix cells


Estimated Enrollment: 1165
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Biological Sample collection
    Cervix cells
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226368

Contacts
Contact: Janick JEAN-MARIE, Master 596592697 ext +33 janick.jean-marie@chu-fortdefrance.fr
Contact: Paul MOURLHOU 596592697 ext +33 paul.mourlhou@chu-fortdefrance.fr

Locations
Martinique
Centre Hospitalier Universitaire de Fort-de-France Not yet recruiting
Fort-de-France, Martinique, 97261
Contact: Sylvie ABEL, MD    596552301 ext +33    sylvie.abel@chu-fortdefrance.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Fondation de France
Centre d'Investigation Clinique-Epidémiologie Clinique Antilles Guyane
Investigators
Study Director: Sylvie ABEL, MD Centre Hospitalier Universitaire de Fort-de-France
  More Information

No publications provided

Responsible Party: RIAM/ Chef Executive Officer, Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier: NCT01226368     History of Changes
Other Study ID Numbers: 10/B/09
Study First Received: October 21, 2010
Last Updated: October 21, 2010
Health Authority: France : CNIL - National Commission for Data Processing and Liberties

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
HIV, HPV, cervical-vaginal smear

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 15, 2014