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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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ClinicalTrials.gov Identifier: NCT03161444
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
University Hospital of Guadeloupe
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:
This study will estimate the 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.

Condition or disease Intervention/treatment Phase
HIV Infections Zika Virus Infection Other: Biological sample collection Not Applicable

Detailed Description:
Zika virus infection is expanding in all tropical and subtropical areas. The presence of Aedes albopictus in southern France raises concerns about the occurrence of outbreaks of indigenous Zika virus transmission. In this context, knowledge of the cumulative impact of the epidemic that affected the Caribbean in 2016 is an important issue for the management of future epidemics and modeling work. Since the Zika virus has not yet been circulated in the Lesser Antilles, the cumulative incidence rate can be estimated by conducting a general population seroprevalence survey at the end of the epidemic, or more simply within a cohort of patients regularly monitored and whose habitat is distributed throughout the study area. Thus, HIV-infected patients who benefit from regular clinical biological monitoring constitute a population sample perfectly adapted to the study of the emergence of the Zika virus in the French West Indies. The cumulative incidence of infection with the chikungunya virus after the 2014 epidemic has thus been estimated at 58% for Martinique and Guadeloupe using this method.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A blood sample collection for the study will be taken to each participant. Each subject enrolled must have previously participated in the study CHIKVIH.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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.
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Zika Virus

Arm Intervention/treatment
Elective patient
Patient who has patricipated to the study CHIKVIH (NCT02553369) will have a blood collection during a follow up visit for HIV infection.
Other: Biological sample collection
A blood sample collection for the study will be taken to each participant Each subject enrolled must have previously participated to the study CHIKVIH.




Primary Outcome Measures :
  1. Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic [ Time Frame: 1 day ]
    Presence or absence of ZIKV-specific IgG antibodies in the serum taken at the end of the Zika epidemic within six months of the official end of the epidemic for each territory of the French west Indies


Secondary Outcome Measures :
  1. Existence or not of clinical signs evocating of an episode of disease with Zika virus. [ Time Frame: 1 day during the study ]
    The clinician in charge of the patient will question him about the occurrence of a clinical episode suggestive of Zika virus infection during the epidemic

  2. 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 ]
    Serological analysis will be performed on biological sample collected in the frame of the heath follow-up of teh patient and stored before the epidemic of Zika Virus disease

  3. 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 ]
    Serological analysis will be performed on biological sample collected in the frame of the heath follow-up of teh patient and stored before the epidemic of Zika Virus disease

  4. 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 ]
    All biological results for CD4 Lymphocyte will be collected retrospectivelly : 6 months before the outbreak of Zika virus , 12 months of the outbreak of Zika virus and 6 months after the outbreak of Zika virus in order to observe its evolution

  5. 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 ]
    All biological results for HIV1 RNA will be collected retrospectivelly : 6 months before the outbreak of Zika virus , 12 months of the outbreak of Zika virus and 6 months after the outbreak of Zika virus in order to observe its evolution



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161444


Contacts
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Contact: Janick JEAN-MARIE, Master 0596 59 26 97 ext +596 janick.jean-marie@chu-martinique.fr
Contact: Isabelle CALMONT, Master 0596 59 26 97 ext +596 isabelle.calmont@chu-martinique.fr

Locations
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France
University Hospital of Martinique Recruiting
Fort-de-France, France, 97200
Contact: Janick JEAN-MARIE, Master    0596 59 26 97 ext +596    janick.jean-marie@chu-martinique.fr   
Contact: isabelle CALMONT, Master    0596 59 26 97 ext +596    isabelle.calmont@chu-martinique.fr   
Principal Investigator: Andre CABIE, MD         
Guadeloupe
University Hospital of Guadeloupe Not yet recruiting
Pointe-à-Pitre, Guadeloupe, 97159
Contact: Elvire Couchy, Master    0590 91 19 30 ext +590    elvire.couchy@chu-guadeloupe.fr   
Principal Investigator: Bruno HOEN, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
University Hospital of Guadeloupe
Investigators
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Principal Investigator: Andre CABIE, MD University Hospital of Martinique
Principal Investigator: Bruno HOEN, MD University Hospital of Gaudeloupe
Study Director: Andre CABIE, MD University Hospital of Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03161444     History of Changes
Other Study ID Numbers: 16/B/06
2016-A01173-48 ( Other Identifier: ANSM )
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections