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)

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.

Study Overview

• Status: Terminated
• Conditions: HIV Infections; Zika Virus Infection
• Intervention / Treatment: Other: Biological sample collection

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.

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guadeloupe
  • Pointe-à-Pitre, Guadeloupe, 97159
    • University Hospital of Guadeloupe
• Martinique
  • Fort-de-France, Martinique, 97200
    • University Hospital of Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Existence or not of clinical signs evocating of an episode of disease with Zika virus.	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	1 day during the study
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.	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	1 day on biological sample collected before the outbreak of Zika virus
Presence or not of Chikungunya-specific antibodies before the outbreak of Zika virus infection, sought after sampling at the end of the chikungunya epidemic.	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	1 day on biological sample collected before the outbreak of Zika virus
Evolution of the CD4 lymphocyte levels before and 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	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
Evolution of the HIV1 RNA levels before and 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	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

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Collaborators: University Hospital of Guadeloupe
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): August 10, 2019
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Zika Virus Infection
• Other Study ID Numbers: 16/B/06; 2016-A01173-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No