Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT03296202
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2017-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Socio-demographic characteristics of people living with the HIV', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)'}], 'secondaryOutcomes': [{'measure': 'HIV infection characteristics of people living with the HIV', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)', 'description': 'group of infection, stage of infection, duration since first serology positive, CD4 nadir, last CD4 measurement, CD4 / CD8 ratio'}, {'measure': 'comorbidities of people living with the HIV', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)'}, {'measure': 'co-infections of people living with the HIV', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)', 'description': 'Hepatitis B, Hepatitis C, cytomegalovirus infection...'}, {'measure': 'Therapeutics description', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)', 'description': 'naïve / treated status, dosage'}, {'measure': 'virological responses', 'timeFrame': 'Each 12 months from baseline for 4 years (M48)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'cohort studies', 'antiretroviral treatment'], 'conditions': ['HIV Infections', 'Antiretroviral Agents']}, 'referencesModule': {'references': [{'pmid': '36624391', 'type': 'DERIVED', 'citation': 'Devos S, Bonnet F, Hessamfar M, Neau D, Vareil MO, Leleux O, Cazanave C, Rouanes N, Duffau P, Lazaro E, Dabis F, Wittkop L, Barger D; ANRS CO3-AQUIVIH-NA-QuAliV. Tobacco, alcohol, cannabis, and illicit drug use and their association with CD4/CD8 cell count ratio in people with controlled HIV: a cross-sectional study (ANRS CO3 AQUIVIH-NA-QuAliV). BMC Infect Dis. 2023 Jan 9;23(1):16. doi: 10.1186/s12879-022-07963-6.'}, {'pmid': '32650781', 'type': 'DERIVED', 'citation': "Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, Rouanes N, Leleux O, Le Marec F, Erramouspe M, Wittkop L, Dabis F, Bonnet F. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes. 2020 Jul 10;18(1):220. doi: 10.1186/s12955-020-01451-8."}, {'pmid': '31850847', 'type': 'DERIVED', 'citation': 'Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Wittkop L, Dabis F, Bonnet F. Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. JMIR Form Res. 2019 Dec 18;3(4):e15013. doi: 10.2196/15013.'}, {'pmid': '29880467', 'type': 'DERIVED', 'citation': "Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Dabis F, Bonnet F. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study. JMIR Res Protoc. 2018 Jun 7;7(6):e147. doi: 10.2196/resprot.9439."}]}, 'descriptionModule': {'briefSummary': 'HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects.\n\nThe main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.', 'detailedDescription': "The survival of people living with HIV (PLHIV) taking antiretroviral therapy (ART) is now close to what is reported in the general population in northern countries. However, PLHIV experience an increased risk of morbidities that the ANRS CO3 Aquitaine Cohort has largely contributed to describe in the last years. Among contributing factors to this excess of morbidity, immune suppression, immune activation, and exposition to cardiovascular and cancer risk factors as well as ageing represent possible intervention targets. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as ART side effects.\n\nMoreover, the global evaluation of health in PLHIV, including psychiatric, neurologic and social determinants and not only biomedical determinants represents one of the public health challenges of the next decade in the field of HIV infection.\n\nThe aim of the present study is to study the emerging morbidity occurring during the course of HIV infection in people treated with ART as well as to describe the tolerance and efficacy of new available ART regimens.\n\nThe follow-up of patients will be performed according to national guidelines. Demographic, clinical, biological and therapeutic data will be captured at each patient's hospital contact according to a standardized questionnaire.\n\nAll events occurring during the course of clinical management will be prospectively registered in the database according to the ICD 10th revision. A biobank will be collected from every consenting PLHIV at inclusion in the cohort and then every two years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients infected with HIV-1 (PLHIV)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years old.\n* Confirmed HIV infection\n* Signed informed consent\n\nExclusion Criteria:\n\n* HIV-2 infection'}, 'identificationModule': {'nctId': 'NCT03296202', 'acronym': 'AquiVIH-NA', 'briefTitle': 'Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort - AquiVIH-NA', 'orgStudyIdInfo': {'id': 'CHUBX 2016/04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV patients', 'description': '7200 patients infected with HIV-1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47923', 'city': 'Agen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick RISPAL, MD', 'role': 'CONTACT', 'email': 'rispalp@ch-agen.fr'}, {'name': 'Patrick RISPAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "service de médecine interne - CH d'Agen", 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'city': 'Angoulême', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agnès RICHE, MD', 'role': 'CONTACT', 'email': 'agnes.riche@ch-angouleme.fr'}, {'name': 'Agnès RICHE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Médecine interne - CH d'Angoulême", 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'zip': '64109', 'city': 'Bayonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc-Olivier VAREIL, MD', 'role': 'CONTACT', 'email': 'movareil@ch-cotebasque.fr'}, {'name': 'Marc-Olivier VAREIL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de maladies infectieuses - CH de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '33075', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick MERCIE, Prof', 'role': 'CONTACT', 'email': 'patrick.mercie@chu-bordeaux.fr'}, {'name': 'Patrick MERCIE, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine inter et maladies infectieuses - Hopital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33075', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice BONNET, Prof', 'role': 'CONTACT', 'email': 'fabrice.bonnet@chu-bordeaux.fr'}, {'name': 'Fabrice BONNET, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - Hôpital Saint-André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MALVY Denis, Prof', 'role': 'CONTACT', 'email': 'denis.malvy@chu-bordeaux.fr'}, {'name': 'Denis MALVY, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier NEAU, Prof', 'role': 'CONTACT', 'email': 'didier.neau@chu-bordeaux.fr'}, {'name': 'Didier NEAU, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DUPON Michel, Prof', 'role': 'CONTACT', 'email': 'michel.dupon@chu-bordeaux.fr'}, {'name': 'DUPON Michel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille RUNEL-BELLIARD, MD', 'role': 'CONTACT', 'email': 'camille.runel@chu-bordeaux.fr'}, {'name': 'Camille RUNEL-BELLIARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service D'Urgences Pédiatriques", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Châtellerault', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine ELSENDOORN, MD', 'role': 'CONTACT', 'email': 'antoine.elsendoorn@ghnv.fr'}, {'name': 'Antoine ELSENDOORN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'médecine interne - CH de Châtellerault', 'geoPoint': {'lat': 46.81705, 'lon': 0.54518}}, {'zip': '40107', 'city': 'Dax', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann GERARD, MD', 'role': 'CONTACT', 'email': 'gerardy@ch-dax.fr'}, {'name': 'Yann GERARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - CH de Dax', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'city': 'Jonzac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry PASDELOUP, MD', 'role': 'CONTACT', 'email': 'thierry.pasdeloup@ch-jonzac.fr'}, {'name': 'Thierry PASDELOUP, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Interne - CH de Jonzac', 'geoPoint': {'lat': 45.44636, 'lon': -0.43485}}, {'zip': '33260', 'city': 'La Teste-de-Buch', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carine COURTAULT, MD', 'role': 'CONTACT', 'email': 'carine.courtault@ch-arcachon.fr'}, {'name': 'Carine COURTAULT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "service de médecine interne - CH d'Arcachon", 'geoPoint': {'lat': 44.63278, 'lon': -1.14513}}, {'zip': '33505', 'city': 'Libourne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene FERRAND, MD', 'role': 'CONTACT', 'email': 'helene.ferrand@ch-libourne.fr'}, {'name': 'Sten DE WITTE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helene FERRAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne - CH de Libourne', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '40024', 'city': 'Mont-de-Marsan', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hajnal-Gabriela ILLES, MD', 'role': 'CONTACT', 'email': 'gabriela.illes@ch-mdm.fr'}, {'name': 'Hajnal-Gabriela ILLES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne - CH de Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'city': 'Orthez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann GERARD, MD', 'role': 'CONTACT', 'email': 'gerardy@ch-dax.fr'}, {'name': 'Yann GERARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "service de médecine interne - CH d'Orthez", 'geoPoint': {'lat': 43.48834, 'lon': -0.77266}}, {'zip': '64000', 'city': 'Pau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric MONLUN, MD', 'role': 'CONTACT', 'email': 'eric.monlun@ch-pau.fr'}, {'name': 'Eric MONLUN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - CH de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-francois.viallard@chu-bordeaux.fr'}, {'name': 'Jean-Luc PELLEGRIN, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - Groupe hospitalier Sud', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24019', 'city': 'Périgueux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe LATASTE, MD', 'role': 'CONTACT', 'email': 'philippe.lataste@ch-perigueux.fr'}, {'name': 'Philippe LATASTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - CH de Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenaël LE MOAL, MD', 'role': 'CONTACT', 'email': 'gwenael.le-moal@chu-poitiers.fr'}, {'name': 'Gwenaël LE MOAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine interne et Maladies Infectieuses - CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Royan', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe MOTTAZ, MD', 'role': 'CONTACT', 'email': 'philippe.mottaz@ch-royan.fr'}, {'name': 'Philippe MOTTAZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine interne - CH de Royan', 'geoPoint': {'lat': 45.62811, 'lon': -1.03153}}, {'city': "Saint-Jean-d'Angély", 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry PASDELOUP, MD', 'role': 'CONTACT', 'email': 'thierry.pasdeloup@ch-angely.fr'}, {'name': 'Thierry PASDELOUP, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Médecine Interne - CH de Saint-Jean-D'Angely", 'geoPoint': {'lat': 45.94408, 'lon': -0.52133}}, {'city': 'Saintes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry PASDELOUP, MD', 'role': 'CONTACT', 'email': 'thierry.pasdeloup@ch-saintonge.fr'}, {'name': 'Thierry PASDELOUP, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médecine Interne - CH de Saintonge', 'geoPoint': {'lat': 45.74742, 'lon': -0.63489}}, {'zip': '47307', 'city': 'Villeneuve-sur-Lot', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle CHOSSAT, MD', 'role': 'CONTACT', 'email': 'isabelle.chossat@ch-stcyr.fr'}, {'name': 'Isabelle CHOSSAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de maladies infecteieuses - CH Saint-Cyr', 'geoPoint': {'lat': 44.40854, 'lon': 0.70415}}], 'centralContacts': [{'name': 'Fabrice BONNET, Prof', 'role': 'CONTACT', 'email': 'fabrice.bonnet@chu-bordeaux.fr', 'phone': '(0)5 56 79 58 26', 'phoneExt': '+33'}, {'name': 'Olivier LELEUX', 'role': 'CONTACT', 'email': 'Olivier.Leleux@u-bordeaux.fr', 'phone': '(0)5 57 57 45 44', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Linda WITTKOP, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ISPED - CHU de Bordeaux'}, {'name': 'Fabrice BONNET, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Agency for Research on AIDS and Viral Hepatitis (ANRS)', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'French Ministry of Health through the COREVIH Aquitaine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}