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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01226368 |
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Date of registration:
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21/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
HP2V-AG |
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Scientific title:
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Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana. |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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455 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01226368 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Martinique
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Contacts
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Name:
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Sylvie ABEL, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Fort-de-France |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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3- Followed in West Indies and French Guiana for His Infection
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4- Acceptance of the Use of Nadis® Medical Files
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1- Women
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2- HIV Infection
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Intervention(s)
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Other: Biological Sample collection
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Primary Outcome(s)
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Presence of human papillomavirus
[Time Frame: 1 day]
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Secondary Outcome(s)
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Presence and the severity of cervical injuries.
[Time Frame: 1 day]
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Characterization of Human papillomavirus genotypes
[Time Frame: 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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