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.

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.



Sponsors


Source

University Hospital Center of Martinique

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-03-21

Completion Date

2018-01-21

Primary Completion Date

2017-11-21

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic
1 day

Secondary Outcome

Measure

Time Frame

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

Enrollment

362

Conditions


Intervention

Intervention Type

Other

Intervention Name


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.

Arm Group Label

Elective patient


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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Andre CABIE, MD
Principal Investigator
University Hospital of Martinique
Bruno HOEN, MD
Principal Investigator
University Hospital of Gaudeloupe
Andre CABIE, MD
Study Director
University Hospital of Martinique

Overall Contact

Last Name

Janick JEAN-MARIE, Master

Phone

0596 59 26 97

Phone Ext

+596

Email



Location

Facility

Status

Contact

Investigator

University Hospital of Martinique
Fort-de-France 97200 France
Recruiting
Last Name: Janick JEAN-MARIE, Master
Phone: 0596 59 26 97
Phone Ext: +596
Email: [email protected]
Last Name: Andre CABIE, MD
Role: Principal Investigator
University Hospital of Guadeloupe
Pointe-à-Pitre 97159 Guadeloupe
Not yet recruiting
Last Name: Elvire Couchy, Master
Phone: 0590 91 19 30
Phone Ext: +590
Email: [email protected]
Last Name: Bruno HOEN, MD
Role: Principal Investigator

Location Countries

Country

France

Guadeloupe



Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-16

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Secondary Id

2016-A01173-48

Number Of Arms

1

Arm Group

Arm Group Label

Elective patient

Arm Group Type

Other

Description

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


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Isabelle CALMONT, Master

Phone

0596 59 26 97

Phone Ext

+596

Email



Acronym

ZIKAVIH

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

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

Masking

No masking



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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