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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)

Primary Purpose

HIV Infections, Zika Virus Infection

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biological sample collection
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Guadeloupe
  • University Hospital of Martinique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Elective patient

Arm Description

Patient who has patricipated to the study CHIKVIH (NCT02553369) will have a blood collection during a follow up visit for HIV infection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
May 16, 2017
Last Updated
March 7, 2022
Sponsor
University Hospital Center of Martinique
Collaborators
University Hospital of Guadeloupe
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1. Study Identification

Unique Protocol Identification Number
NCT03161444
Brief 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.
Acronym
ZIKAVIH
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Active circulation of dengue virus in the region of the study that may affect the result of zika serology
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
March 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
Collaborators
University Hospital of Guadeloupe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Zika Virus Infection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elective patient
Arm Type
Other
Arm Description
Patient who has patricipated to the study CHIKVIH (NCT02553369) will have a blood collection during a follow up visit for HIV infection.
Intervention Type
Other
Intervention Name(s)
Biological sample collection
Intervention Description
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 Measure Information:
Title
Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Existence or not of clinical signs evocating of an episode of disease with Zika virus.
Description
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
Time Frame
1 day during the study
Title
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.
Description
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
Time Frame
1 day on biological sample collected before the outbreak of Zika virus
Title
Presence or not of Chikungunya-specific antibodies before the outbreak of Zika virus infection, sought after sampling at the end of the chikungunya epidemic.
Description
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
Time Frame
1 day on biological sample collected before the outbreak of Zika virus
Title
Evolution of the CD4 lymphocyte levels before and after the outbreak of Zika virus
Description
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
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
Title
Evolution of the HIV1 RNA levels before and after the outbreak of Zika virus
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre CABIE, MD
Organizational Affiliation
University Hospital of Martinique
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno HOEN, MD
Organizational Affiliation
University Hospital of Gaudeloupe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre CABIE, MD
Organizational Affiliation
University Hospital of Martinique
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Guadeloupe
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
Facility Name
University Hospital of Martinique
City
Fort-de-France
ZIP/Postal Code
97200
Country
Martinique

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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