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

NCT01226368 | Completed

• 1 other identifier: 10/B/09
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV, HPV, cervical-vaginal smear

Outcome Measures

Primary Outcomes (1)

• Presence of human papillomavirus

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

  1 day

Secondary Outcomes (2)

• Characterization of Human papillomavirus genotypes

  1 day

• Presence and the severity of cervical injuries.

  1 day

Interventions

Biological Sample collection OTHER

Cervix cells

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Universitaire de Fort-de-France

Fort-de-France, 97261, Martinique

Location

Biospecimen

Retention: SAMPLES WITH DNA

cervix cells

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie ABEL, MD

  University Hospital Center of Martinique

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

MA (1)