HIV InfectionsZIKAVIHNCT03161444
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.
A study testing Biological sample collection in people with HIV Infections and Zika Virus Infection, run by University Hospital Center of Martinique at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Zika Virus Infection
- What is being tested?
- Biological sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Mar 2017to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient who has stayed in another area at risk of transmission of the Zika virus
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Zika Virus Infection
- Being tested
- Biological sample collection
- Medical subject headings
- HIV Infections, Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
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
Measured: 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.
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
Measured: 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.
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
Measured: 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
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start21 Mar 2017
- Primary completion10 Aug 2019
- Study completion2 Mar 2020
Why it stopped: Active circulation of dengue virus in the region of the study that may affect the result of zika serology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Guadeloupe
- Responsible party
- Sponsor
- Investigators
- Andre CABIE, MD, Principal investigator, University Hospital of MartiniqueBruno HOEN, MD, Principal investigator, University Hospital of GaudeloupeAndre CABIE, MD, Study director, University Hospital of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161444
- Sponsor's protocol ID
- 16/B/06
- Other IDs
- 2016-A01173-48
- Acronym
- ZIKAVIH
- Status last verified
- Mar 2022
- First submitted
- 16 May 2017
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03161444
- Acronym / sponsor ID
- ZIKAVIH / 16/B/06
- Conditions
- HIV Infections, Zika Virus Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Active circulation of dengue virus in the region of the study that may affect the result of zika serology
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- University Hospital of Guadeloupe
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Elective patient | Other | Other: Biological sample collectionPatient who has patricipated to the study CHIKVIH (NCT02553369) will have a blood collection during a follow up visit for HIV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient who has stayed in another area at risk of transmission of the Zika virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionA blood sample collection for the study will be taken to each participant Each subject enrolled must have previously participated to the study CHIKVIH. | Other | Elective patient |
Primary outcome
Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic
Time frame: 1 day
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
5 secondary outcomes
Existence or not of clinical signs evocating of an episode of disease with Zika virus.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
Evolution of the HIV1 RNA levels before and after the outbreak of Zika virus
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
Results and safety
The study was stopped early (reason given: Active circulation of dengue virus in the region of the study that may affect the result of zika serology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection in people with HIV Infections and Zika Virus Infection, run by University Hospital Center of Martinique at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Active circulation of dengue virus in the region of the study that may affect the result of zika serology). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or not of Zika virus-specific immunoglobulin G antibodies in the serum taken after the epidemic (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.