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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 21, 2010 | ||||||||
| Last Updated Date | October 21, 2010 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana. | ||||||||
| Official Title ICMJE | Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana. | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: cervix cells |
||||||||
| 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. |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Other: Biological Sample collection
Cervix cells |
||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 1165 | ||||||||
| Estimated Completion Date | October 2012 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Martinique | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01226368 | ||||||||
| Other Study ID Numbers ICMJE | 10/B/09 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | RIAM/ Chef Executive Officer, Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Verification Date | October 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||