Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT02553369
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D065632', 'term': 'Chikungunya Fever'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or not of chikungunya virus-specific immunoglobulin G antibodies (Elisa test)', 'timeFrame': '1 day', 'description': 'Presence or not of chikungunya virus-specific immunoglobulin G antibodies'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pain', 'timeFrame': '6 , 12 , 18 months after the first symptoms of chikungunya virus infection', 'description': 'Score range from 0 (No pain) to 10 (worst possible pain)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Chikungunya Virus Infection']}, 'referencesModule': {'references': [{'pmid': '17448935', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18728479', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18298600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19112735', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18725980', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23176378', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18651905', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17721376', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18351797', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18662384', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24721539', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33836004', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDuring 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.\n\nIn this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.\n\nAs 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.\n\nThe 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 .\n\nPrimary objective :\n\nTo 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\n\nSecondary objective :\n\nTo 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient followed for HIV infection at the 2 investigator centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\> 18 years old)\n* Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)\n* resident in Martinique /Guadeloupe ( French West Indies)\n* informed consent signed by the patient\n\nExclusion Criteria:\n\n* patient who lived more than 6 month in an risk area for chikungunya virus infection\n* patient with or documented chronic rheumatism\n* patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study\n* patient who has planned to live outside French West Indies during the follow up period'}, 'identificationModule': {'nctId': 'NCT02553369', 'acronym': 'ChikVIH', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '14/B/18'}, 'secondaryIdInfos': [{'id': '2014-A01504-43', 'type': 'REGISTRY', 'domain': 'ID RCB'}, {'id': '2014/82', 'type': 'REGISTRY', 'domain': 'N° CPP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled patients', 'description': 'Patient randomly enrolled in the study within a cohort of patient followed for HIV infection.', 'interventionNames': ['Other: Biological sample collection']}], 'interventions': [{'name': 'Biological sample collection', 'type': 'OTHER', 'description': 'A blood sample is collected during a follow up visit for HIV infection.', 'armGroupLabels': ['Enrolled patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97159', 'city': 'Pointe à Pitre', 'state': 'Guadeloupe', 'country': 'France', 'facility': 'CHU de Guadeloupe', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '97200', 'city': 'Fort-de-France', 'state': 'Martinique', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Fort-de-France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}