Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana. (HP2V-AG)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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
- 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) |
-
Other: Biological Sample collection
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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| 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 |
| 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 | |
| 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 February 26, 2013
