1- Women Clinical Trial
— HP2V-AGOfficial title:
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.
| Status | Completed |
| Enrollment | 455 |
| Est. completion date | March 2014 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Martinique | Centre Hospitalier Universitaire de Fort-de-France | Fort-de-France |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Fort-de-France | Clinique Antilles-Guyane, Fondation de France |
Martinique,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Characterization of Human papillomavirus genotypes | Characterization of Human papillomavirus genotype found in women's cervical smear infected with HIV and followed in West Indies and French Guiana | 1 day | No |
| Secondary | Presence and the severity of cervical injuries. | 1 day | No |