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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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21 March 2022 |
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Main ID: |
NCT03161444 |
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Date of registration:
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16/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection.
ZIKAVIH |
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Scientific title:
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Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection. |
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Date of first enrolment:
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March 21, 2017 |
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Target sample size:
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354 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03161444 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Guadeloupe
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Martinique
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Contacts
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Name:
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Bruno HOEN, 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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University Hospital of Gaudeloupe |
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Name:
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Andre CABIE, 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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University Hospital of Martinique |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (> 18 years pold)
- Followed for HIV infection at the 2 investigators centers (1 located at Martinique and
1 at Guadeloupe)
- Resident in Martinique /Guadeloupe (French West Indies) betwwen 01JAN2016 and
31DEC2016
- Affiliate or beneficiary of a social security scheme.
- Informed consent signed by the patient
Exclusion Criteria:
- Patient who has stayed in another area at risk of transmission of the Zika virus
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Zika Virus 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 or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic
[Time Frame: 1 day]
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Secondary Outcome(s)
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Evolution of the HIV1 RNA levels before and after the outbreak of Zika virus
[Time Frame: 6 months before the outbreak of Zika virus ; 12 months of the outbreak of Zika virus; First 6 months after the outbreak of Zika virus]
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Presence or not of Dengue virus specific antibodies before the outbreak of Zika virus infection, sought on the samples taken at the end of the chikungunya epidemic.
[Time Frame: 1 day on biological sample collected before the outbreak of Zika virus]
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Evolution of the CD4 lymphocyte levels before and after the outbreak of Zika virus
[Time Frame: 6 months before the outbreak of Zika virus ; 12 months of the outbreak of Zika virus; First 6 months after the outbreak of Zika virus]
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Existence or not of clinical signs evocating of an episode of disease with Zika virus.
[Time Frame: 1 day during the study]
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Presence or not of Chikungunya-specific antibodies before the outbreak of Zika virus infection, sought after sampling at the end of the chikungunya epidemic.
[Time Frame: 1 day on biological sample collected before the outbreak of Zika virus]
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Secondary ID(s)
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16/B/06
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2016-A01173-48
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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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