HIV InfectionsChikVIHNCT02553369

Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection

An observational study of HIV Infections and Chikungunya Virus Infection, run by University Hospital Center of Martinique at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak. During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Chikungunya Virus Infection
What is being tested?: Biological sample collection
How many people: 388 participants
Where: 2 sitesFrance
Study dates: Feb 2015to Apr 2016
Phase: Observational
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

Study population: patient followed for HIV infection at the 2 investigator centers.

Who may be able to join

Adult (> 18 years old)
Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)
resident in Martinique /Guadeloupe ( French West Indies)
informed consent signed by the patient

Who cannot join

patient who lived more than 6 month in an risk area for chikungunya virus infection
patient with or documented chronic rheumatism
patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study
patient who has planned to live outside French West Indies during the follow up period

Trial locations and contacts

2 sites in 1 country.

France2 sites

Centre Hospitalier Universitaire de Fort-de-France
Fort-de-France, Martinique, 97200
CHU de Guadeloupe
Pointe à Pitre, Guadeloupe, 97159

Other trials in France

About this study

Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

As the chikungunya virus had never circulated in the Caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. Another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied.

The follow up of patients infected by the human immunodeficiency virus (HIV) in the French West Indies is almost exclusively performed in hospitals in department of Infectious and Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. This patient cohort is well suited to study the emergence of Chikungunya in the French West Indie .

Primary objective :

To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the French West Indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by HIV and representative of the general population of Martinique and Guadeloupe

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population

Conditions: HIV Infections, Chikungunya Virus Infection
Being tested: Biological sample collection
Medical subject headings: HIV Infections, Chikungunya Fever

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 is collected during a follow up visit for HIV infection.

Study groups in NCT02553369
Study group	Role	What they receive
Enrolled patients		Patient randomly enrolled in the study within a cohort of patient followed 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 chikungunya virus-specific immunoglobulin G antibodies (Elisa test)
Presence or not of chikungunya virus-specific immunoglobulin G antibodies
Measured: 1 day

Secondary outcomes (1)

Change From Baseline in Pain
Score range from 0 (No pain) to 10 (worst possible pain)
Measured: 6 , 12 , 18 months after the first symptoms of chikungunya virus infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Apr 2016

First posted17 Sep 2015 (estimated)
Study startFeb 2015
Primary completionOct 2015
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02553369
Sponsor's protocol ID: 14/B/18
Other IDs: 2014-A01504-43, 2014/82
Acronym: ChikVIH
Status last verified: Jul 2016
First submitted: 14 Sep 2015
Last updated: 26 Jul 2016
Results posted: No
Data monitoring committee: No

Publications

Pialoux G, Gauzere BA, Jaureguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. doi: 10.1016/S1473-3099(07)70107-X.
PubMed 17448935
Farnon EC, Sejvar JJ, Staples JE. Severe disease manifestations associated with acute chikungunya virus infection. Crit Care Med. 2008 Sep;36(9):2682-3. doi: 10.1097/CCM.0b013e3181843d94. No abstract available.
PubMed 18728479
Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC; workgroup "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007. Transfusion. 2008 Jul;48(7):1333-41. doi: 10.1111/j.1537-2995.2008.01646.x. Epub 2008 Feb 22.
PubMed 18298600
Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G. The Chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus. 2008 Oct;6(4):199-210. doi: 10.2450/2008.0016-08.
PubMed 19112735
Sissoko D, Moendandze A, Malvy D, Giry C, Ezzedine K, Solet JL, Pierre V. Seroprevalence and risk factors of chikungunya virus infection in Mayotte, Indian Ocean, 2005-2006: a population-based survey. PLoS One. 2008 Aug 26;3(8):e3066. doi: 10.1371/journal.pone.0003066.
PubMed 18725980
Appassakij H, Khuntikij P, Kemapunmanus M, Wutthanarungsan R, Silpapojakul K. Viremic profiles in asymptomatic and symptomatic chikungunya fever: a blood transfusion threat? Transfusion. 2013 Oct;53(10 Pt 2):2567-74. doi: 10.1111/j.1537-2995.2012.03960.x. Epub 2012 Nov 26.
PubMed 23176378
Bianco C. Dengue and Chikungunya viruses in blood donations: risks to the blood supply? Transfusion. 2008 Jul;48(7):1279-81. doi: 10.1111/j.1537-2995.2008.01806.x. No abstract available.
PubMed 18651905
Ramful D, Carbonnier M, Pasquet M, Bouhmani B, Ghazouani J, Noormahomed T, Beullier G, Attali T, Samperiz S, Fourmaintraux A, Alessandri JL. Mother-to-child transmission of Chikungunya virus infection. Pediatr Infect Dis J. 2007 Sep;26(9):811-5. doi: 10.1097/INF.0b013e3180616d4f.
PubMed 17721376
Gerardin P, Barau G, Michault A, Bintner M, Randrianaivo H, Choker G, Lenglet Y, Touret Y, Bouveret A, Grivard P, Le Roux K, Blanc S, Schuffenecker I, Couderc T, Arenzana-Seisdedos F, Lecuit M, Robillard PY. Multidisciplinary prospective study of mother-to-child chikungunya virus infections on the island of La Reunion. PLoS Med. 2008 Mar 18;5(3):e60. doi: 10.1371/journal.pmed.0050060.
PubMed 18351797
Gerardin P, Guernier V, Perrau J, Fianu A, Le Roux K, Grivard P, Michault A, de Lamballerie X, Flahault A, Favier F. Estimating Chikungunya prevalence in La Reunion Island outbreak by serosurveys: two methods for two critical times of the epidemic. BMC Infect Dis. 2008 Jul 28;8:99. doi: 10.1186/1471-2334-8-99.
PubMed 18662384
Van Bortel W, Dorleans F, Rosine J, Blateau A, Rousset D, Matheus S, Leparc-Goffart I, Flusin O, Prat C, Cesaire R, Najioullah F, Ardillon V, Balleydier E, Carvalho L, Lemaitre A, Noel H, Servas V, Six C, Zurbaran M, Leon L, Guinard A, van den Kerkhof J, Henry M, Fanoy E, Braks M, Reimerink J, Swaan C, Georges R, Brooks L, Freedman J, Sudre B, Zeller H. Chikungunya outbreak in the Caribbean region, December 2013 to March 2014, and the significance for Europe. Euro Surveill. 2014 Apr 3;19(13):20759. doi: 10.2807/1560-7917.es2014.19.13.20759. No abstract available.
PubMed 24721539
Curlier E, Fagour L, Herrmann-Storck C, Staelen A, Vingadassalom I, Breurec S, Abel S, Pierre-Francois S, Jean-Marie J, Laouenan C, Cesaire R, Hoen B, Cabie A. Seroprevalence of chikungunya virus infection among HIV-infected adults in French Caribbean Islands of Martinique and Guadeloupe in 2015: A cross-sectional study. PLoS Negl Trop Dis. 2021 Apr 9;15(4):e0009267. doi: 10.1371/journal.pntd.0009267. eCollection 2021 Apr.
PubMed 33836004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection
ClinicalTrials.gov ID: NCT02553369
Acronym / sponsor ID: ChikVIH / 14/B/18
Conditions: HIV Infections, Chikungunya Virus Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: University Hospital Center of MartiniqueUniversity, hospital or other
Study start: Feb 2015
Primary completion: Oct 2015 (actual)
Study completion: Apr 2016 (actual)
First posted: 17 Sep 2015 (estimated)
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.

Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

Primary objective :

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Enrolled patients	–	Other: Biological sample collectionPatient randomly enrolled in the study within a cohort of patient followed for HIV infection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patient followed for HIV infection at the 2 investigator centers.

Key inclusion criteria (4 listed)

Adult (> 18 years old)
Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)
resident in Martinique /Guadeloupe ( French West Indies)
informed consent signed by the patient

Key exclusion criteria (4 listed)

patient who lived more than 6 month in an risk area for chikungunya virus infection
patient with or documented chronic rheumatism
patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study
patient who has planned to live outside French West Indies during the follow up period

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 is collected during a follow up visit for HIV infection.	Other	Enrolled patients

Primary outcome

Presence or not of chikungunya virus-specific immunoglobulin G antibodies (Elisa test)
Time frame: 1 day
Presence or not of chikungunya virus-specific immunoglobulin G antibodies

1 secondary outcome

Change From Baseline in Pain
Time frame: 6 , 12 , 18 months after the first symptoms of chikungunya virus infection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Background: PubMed 17448935Pialoux G, Gauzere BA, Jaureguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. doi: 10.1016/S1473-3099(07)70107-X.
Background: PubMed 18728479Farnon EC, Sejvar JJ, Staples JE. Severe disease manifestations associated with acute chikungunya virus infection. Crit Care Med. 2008 Sep;36(9):2682-3. doi: 10.1097/CCM.0b013e3181843d94. No abstract available.
Background: PubMed 18298600Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC; workgroup "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007. Transfusion. 2008 Jul;48(7):1333-41. doi: 10.1111/j.1537-2995.2008.01646.x. Epub 2008 Feb 22.
Background: PubMed 19112735Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G. The Chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus. 2008 Oct;6(4):199-210. doi: 10.2450/2008.0016-08.
Background: PubMed 18725980Sissoko D, Moendandze A, Malvy D, Giry C, Ezzedine K, Solet JL, Pierre V. Seroprevalence and risk factors of chikungunya virus infection in Mayotte, Indian Ocean, 2005-2006: a population-based survey. PLoS One. 2008 Aug 26;3(8):e3066. doi: 10.1371/journal.pone.0003066.
Background: PubMed 23176378Appassakij H, Khuntikij P, Kemapunmanus M, Wutthanarungsan R, Silpapojakul K. Viremic profiles in asymptomatic and symptomatic chikungunya fever: a blood transfusion threat? Transfusion. 2013 Oct;53(10 Pt 2):2567-74. doi: 10.1111/j.1537-2995.2012.03960.x. Epub 2012 Nov 26.
Background: PubMed 18651905Bianco C. Dengue and Chikungunya viruses in blood donations: risks to the blood supply? Transfusion. 2008 Jul;48(7):1279-81. doi: 10.1111/j.1537-2995.2008.01806.x. No abstract available.
Background: PubMed 17721376Ramful D, Carbonnier M, Pasquet M, Bouhmani B, Ghazouani J, Noormahomed T, Beullier G, Attali T, Samperiz S, Fourmaintraux A, Alessandri JL. Mother-to-child transmission of Chikungunya virus infection. Pediatr Infect Dis J. 2007 Sep;26(9):811-5. doi: 10.1097/INF.0b013e3180616d4f.
Background: PubMed 18351797Gerardin P, Barau G, Michault A, Bintner M, Randrianaivo H, Choker G, Lenglet Y, Touret Y, Bouveret A, Grivard P, Le Roux K, Blanc S, Schuffenecker I, Couderc T, Arenzana-Seisdedos F, Lecuit M, Robillard PY. Multidisciplinary prospective study of mother-to-child chikungunya virus infections on the island of La Reunion. PLoS Med. 2008 Mar 18;5(3):e60. doi: 10.1371/journal.pmed.0050060.
Background: PubMed 18662384Gerardin P, Guernier V, Perrau J, Fianu A, Le Roux K, Grivard P, Michault A, de Lamballerie X, Flahault A, Favier F. Estimating Chikungunya prevalence in La Reunion Island outbreak by serosurveys: two methods for two critical times of the epidemic. BMC Infect Dis. 2008 Jul 28;8:99. doi: 10.1186/1471-2334-8-99.
Background: PubMed 24721539Van Bortel W, Dorleans F, Rosine J, Blateau A, Rousset D, Matheus S, Leparc-Goffart I, Flusin O, Prat C, Cesaire R, Najioullah F, Ardillon V, Balleydier E, Carvalho L, Lemaitre A, Noel H, Servas V, Six C, Zurbaran M, Leon L, Guinard A, van den Kerkhof J, Henry M, Fanoy E, Braks M, Reimerink J, Swaan C, Georges R, Brooks L, Freedman J, Sudre B, Zeller H. Chikungunya outbreak in the Caribbean region, December 2013 to March 2014, and the significance for Europe. Euro Surveill. 2014 Apr 3;19(13):20759. doi: 10.2807/1560-7917.es2014.19.13.20759. No abstract available.
Derived from this study: PubMed 33836004Curlier E, Fagour L, Herrmann-Storck C, Staelen A, Vingadassalom I, Breurec S, Abel S, Pierre-Francois S, Jean-Marie J, Laouenan C, Cesaire R, Hoen B, Cabie A. Seroprevalence of chikungunya virus infection among HIV-infected adults in French Caribbean Islands of Martinique and Guadeloupe in 2015: A cross-sectional study. PLoS Negl Trop Dis. 2021 Apr 9;15(4):e0009267. doi: 10.1371/journal.pntd.0009267. eCollection 2021 Apr.

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Chikungunya Virus Infection, run by University Hospital Center of Martinique at 2 sites in France.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jul 2016. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 chikungunya virus-specific immunoglobulin G antibodies (Elisa test) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02553369, which also lists 12 linked publications.

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 26 Jul 2016.