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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Verified May 2017 by University Hospital Center of Martinique

Sponsor:

Collaborator:

University Hospital of Guadeloupe

Information provided by (Responsible Party):

University Hospital Center of Martinique

ClinicalTrials.gov Identifier:

NCT03161444

First received: May 16, 2017

Last updated: May 18, 2017

Last verified: May 2017

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.

HIV Infections
Zika Virus Infection
Other: Biological sample collection

Study Type: Interventional
Study Design: 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: No masking
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.

Primary Outcome Measures:

Secondary Outcome Measures:

  • 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

  • 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

  • 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

  • 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

  • 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

Estimated Enrollment: 362
Actual Study Start Date: March 21, 2017
Estimated Study Completion Date: January 21, 2018
Estimated Primary Completion Date: November 21, 2017 (Final data collection date for primary outcome measure)
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.

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.

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03161444

University Hospital of Martinique
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         
University Hospital of Guadeloupe
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         

University Hospital Center of Martinique

University Hospital of Guadeloupe

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

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 )
Study First Received: May 16, 2017
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Zika Virus Infection
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

ClinicalTrials.gov processed this record on May 19, 2017