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.

HIV Infections Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03161444
• Other study ID #: 16/B/06
• Secondary ID: 2016-A01173-48
• Status: Terminated
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: March 2022
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 354
• Est. completion date: March 2, 2020
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Guadeloupe	University Hospital of Guadeloupe	Pointe-à-Pitre
Martinique	University Hospital of Martinique	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	University Hospital of Guadeloupe

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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