Clinical trial NCT03161444: 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.
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
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
Zika Virus Infection
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: University Hospital of Guadeloupe
First posted: 2017-05-19
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic
timeFrame: 1 day
Secondary outcomes:
measure: Existence or not of clinical signs evocating of an episode of disease with Zika virus.
timeFrame: 1 day during the study
measure: 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.
timeFrame: 1 day on biological sample collected before the outbreak of Zika virus
measure: Presence or not of Chikungunya-specific antibodies before the outbreak of Zika virus infection, sought after sampling at the end of the chikungunya epidemic.
timeFrame: 1 day on biological sample collected before the outbreak of Zika virus
measure: Evolution of the CD4 lymphocyte levels before and after the outbreak of Zika virus
timeFrame: 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
measure: Evolution of the HIV1 RNA levels before and after the outbreak of Zika virus
timeFrame: 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
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: University Hospital of Guadeloupe
city: Fort-de-France
country: Martinique
facility: University Hospital of Martinique
Study officials:
affiliation: University Hospital of Martinique
name: Andre CABIE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Gaudeloupe
name: Bruno HOEN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Martinique
name: Andre CABIE, MD
role: STUDY_DIRECTOR
References: