Clinical trial NCT01226368: Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
Official title: Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Clinique Antilles-Guyane
First posted: 2010-10-22
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Presence of human papillomavirus
timeFrame: 1 day
Secondary outcomes:
measure: Characterization of Human papillomavirus genotypes
timeFrame: 1 day
measure: Presence and the severity of cervical injuries.
timeFrame: 1 day
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: Centre Hospitalier Universitaire de Fort-de-France
Study officials:
affiliation: University Hospital Center of Martinique
name: Sylvie ABEL, MD
role: STUDY_DIRECTOR
References: