Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT06302933
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases\n\n* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.\n* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 451}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of sCD14 (µg/ml). Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of BAFF using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of CXCL13 using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of TNF-α (pg/ml). Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of IL-10 (pg/ml). Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of IP-10 (pg/ml). Levels of these biomarkers will be compared across all groups.'}, {'measure': 'Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma', 'timeFrame': '18 months', 'description': 'Measure of TRAIL (ng/ml). Levels of these biomarkers will be compared across all groups'}], 'secondaryOutcomes': [{'measure': '- Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B', 'timeFrame': '18 months', 'description': 'Serum concentrations of human IgG antibodies against tetanus-toxoid, pertussis, and viral hepatitis B will be measured using commercially available ELISA quantification kits and results will be given as IU/mL'}, {'measure': '- Functional and phenotypic characterization of B and T lymphocytes', 'timeFrame': '18 months', 'description': 'Level (cells/μL or percentage) of T and B-cell lymphocytes subpopulations will be assess in blood using flow cytometry. Functional characterization of T and B lymphocytes will be done by cell culture following by cytokine production titration'}, {'measure': '- Size of the HIV reservoir', 'timeFrame': '18 months', 'description': 'Measure total (copies/million PBMC), integrated (copies/million PBMC), unintegrated (copies/million PBMC) HIV DNA level in Peripheral Blood Mononuclear Cells (PBMC)'}, {'measure': '- Residual viremia in perinatally HIV-infected adolescent', 'timeFrame': '18 months', 'description': 'Any detectable HIV-RNA below 50 copies/mL'}, {'measure': '- Level of HIV plasma p24', 'timeFrame': '18 months', 'description': 'Measure plasma level of HIV p24 antigen (fg/ml) using ultrasentsitive technique called Simoa (Single molecule array)'}, {'measure': '- HLA phenotype and the KIR genotypes', 'timeFrame': '18 months', 'description': 'HLA-B (27 et 57), HLA-B35 ou 53, HLA-C16:01+KIR2DL3+'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon\n\nThe hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:\n\n* Immunological aspect: lack of humoral response or immune activation\n* Virological aspect: Reduced HIV reservoir size\n* Determine the HLA phenotype in the different groups of children included and the KIR genotypes.', 'detailedDescription': "There will be two phases of the study :\n\n* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.\n* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nCase control study\n\n* Children included and followed in the ANRS 12225 study - Pediacam III\n* Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.\n\nControl (4 groups)\n\n* HIV-infected children with positive serology and viral load (VL) \\<400 copies /ml\n* HIV-infected children with positive serology and VL ≥400 copies / ml\n* HIV-uninfected children born to HIV-positive mothers\n* HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature \\<37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).\n\nCross sectional study Inclusion criteria\n\n* All children still followed in the ANRS - Pediacam III cohort\n* Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.\n\nExclusion Criteria:\n\n* Refusal by one of the parents or the guardian for the child's participation in the study\n* No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)"}, 'identificationModule': {'nctId': 'NCT06302933', 'acronym': 'PediacamNEG', 'briefTitle': 'Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms', 'orgStudyIdInfo': {'id': 'ANRS 12414 PediacamNEG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Children enrolled in Pediacam III ANRS12225 cohort', 'interventionNames': ['Biological: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Blood samples collected from children followed in the Pediacam III ANRS12225 cohort', 'armGroupLabels': ['Children enrolled in Pediacam III ANRS12225 cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4035', 'city': 'Douala', 'status': 'NOT_YET_RECRUITING', 'country': 'Cameroon', 'contacts': [{'name': 'Astrid Moukoko, Dr', 'role': 'CONTACT', 'email': 'astridmoukoko@gmail.com', 'phone': '00237699 14 90 47'}], 'facility': 'Hôpital de Jour - Hôpital Laquintinie de Douala', 'geoPoint': {'lat': 4.04827, 'lon': 9.70428}}, {'zip': '1274', 'city': 'Yaoundé', 'status': 'RECRUITING', 'country': 'Cameroon', 'contacts': [{'name': 'Francis A Ndongo, Dr', 'role': 'CONTACT', 'email': 'atebfranc@gmail.com', 'phone': '00237 677 33 00 55'}], 'facility': 'Unité Pédiatrique de Jour - Centre Mère et Enfant de la Fondation Chantal Biya', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'zip': '5777', 'city': 'Yaoundé', 'status': 'RECRUITING', 'country': 'Cameroon', 'contacts': [{'name': 'Suzie T Ndiang, Dr', 'role': 'CONTACT', 'email': 'ndiangsuzie@yahoo.fr', 'phone': '00237 679 53 86 71'}], 'facility': "Service de Pédiatrie - Centre Hospitalier d'Essos", 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}], 'centralContacts': [{'name': 'Mathurin C Tejiokem, Doctor', 'role': 'CONTACT', 'email': 'tejiokem@pasteur-yaounde.org', 'phone': '00237222231803'}, {'name': 'Albert Faye, Doctor', 'role': 'CONTACT', 'email': 'albert.faye@rdb.ap-hop-paris.fr', 'phone': '0033140035361'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centre Pasteur du Cameroun', 'class': 'OTHER'}, {'name': 'Centre Mère et Enfant de la Fondation Chantal Biya', 'class': 'OTHER'}, {'name': "Centre Hospitalier D'essos", 'class': 'OTHER'}, {'name': 'Hospital General De Douala', 'class': 'OTHER'}, {'name': 'CH Orléans', 'class': 'UNKNOWN'}, {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, {'name': 'Hopital Universitaire Robert-Debre', 'class': 'OTHER'}, {'name': 'Université Paris-Sud', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}