NCT03161444

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable hiv-infections

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

May 16, 2017

Last Update Submit

March 7, 2022

Conditions

HIV InfectionsZika Virus Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Existence or not of clinical signs evocating of an episode of disease with Zika virus.

    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.

    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.

    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

    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

    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

Study Arms (1)

Elective patient

OTHER

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

Interventions

Biological sample collectionOTHER

A blood sample collection for the study will be taken to each participant Each subject enrolled must have previously participated to the study CHIKVIH.

Elective patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who has stayed in another area at risk of transmission of the Zika virus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

Location

University Hospital of Martinique

Fort-de-France, 97200, Martinique

Location

MeSH Terms

Conditions

HIV InfectionsZika Virus Infection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsFlavivirus InfectionsFlaviviridae Infections

Study Officials

  • Andre CABIE, MD

    University Hospital of Martinique

    PRINCIPAL INVESTIGATOR

  • Bruno HOEN, MD

    University Hospital of Gaudeloupe

    PRINCIPAL INVESTIGATOR

  • Andre CABIE, MD

    University Hospital of Martinique

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A blood sample collection for the study will be taken to each participant. Each subject enrolled must have previously participated in the study CHIKVIH.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

March 21, 2017

Primary Completion

August 10, 2019

Study Completion

March 2, 2020

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GU(1)MA(1)