Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 9:26 AM
Study NCT ID:
NCT06913959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)
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_WITHOUT_DNA', 'description': 'Blood samples, 2x 5ml EDTA (ethylenediaminetetraacetic acid)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Study the current molecular epidemiology of HIV 1 non-M variant resistance in Cameroon', 'timeFrame': '1 day', 'description': 'Proportion of non-M HIV-1 samples characterized for resistance among the samples collected from participants included in the project'}], 'primaryOutcomes': [{'measure': 'Prevalence of non-M HIV-1 in Cameroon', 'timeFrame': '1 day', 'description': 'Number of participants infected with non-M HIV-1 included compared to the total expected number of inclusions'}], 'secondaryOutcomes': [{'measure': 'Investigate the current molecular epidemiology of resistance in non-M HIV-1 variants in Cameroon', 'timeFrame': '1 Day', 'description': 'Proportion of non-M HIV-1 samples characterized genotypically among the samples collected from participants included in the project'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV genetic diversity', 'HIV-1 non-M variants'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.', 'detailedDescription': 'HIV-1 is divided four distinct groups: M (major) which represents the pandemic strains while others groups O (outlier), N (non M, non O) and P are called non-M variants. Group O (HIV-O) is more divergent, endemic in Central Africa and Cameroon, where it represents about 1% of HIV infections. These variants are characterized by an important genetic divergence from pandemic HIV-1 group M (HIV-M), which impacts on the diagnosis, monitoring and treatment of infected patients. Although discovered in 1990, and emerged at the same time as HIV-M, no data of epidemiology, natural history and evolution of the genetic diversity of these variants is currently available. The few knowledge available to date come from sporadic cases, mainly through studies in Yaoundé. It is therefore essential to improve current knowledge on these variants and their consequences on infected patients.\n\nThe aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective phase : Dried Blood Spot samples tested positive for HIV during the Demographic health surveys in Cameroon 2011 and 2018 surveys, serotyping for HIV.\n\nProspective phase : Individuals who came to Center Pasteur Cameroon in Yaoundé or Garoua for HIV screening or viral load monitoring, serotyping of HIV for positive samples.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All available samples tested positive for HIV during the national Health survey of Cameroon in 2011 And 2018\n* All Individuals who came to Centre Pasteur in Yaoundé or Garoua for HIV screening or viral load monitoring.\n\nExclusion Criteria:\n\n* Insufficient quantity or degraded Dried Blood Spot samples\n* All HIV-positive individuals aged less than 21 years, infected with a Group M HIV-1 virus, or those who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06913959', 'acronym': 'OBSOCAM', 'briefTitle': 'HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)', 'orgStudyIdInfo': {'id': 'ANRS0098s'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective', 'description': 'Dried Blood Spot samples tested positive for HIV during the previous national epidemiologic surveys Demographic health surveys in Cameroon', 'interventionNames': ['Diagnostic Test: Prospective']}, {'label': 'Prospective', 'description': 'Individuals who came to Center Pasteur in Yaounde or Garoua for HIV screening or viral load monitoring', 'interventionNames': ['Diagnostic Test: Prospective']}], 'interventions': [{'name': 'Prospective', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples will be collected in order to meet the objectives of this substudy and possibly for complementary research', 'armGroupLabels': ['Prospective', 'Retrospective']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mariam Gharib, PhD', 'role': 'CONTACT', 'email': 'mariam.gharib@inserm.fr', 'phone': '0144236442'}, {'name': 'Elodie Alessandri-Gradt, ParmD PhD', 'role': 'CONTACT', 'email': 'elodie.alessandri@chu-rouen.fr', 'phone': '+33232855885'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}, {'name': 'Centre Pasteur du Cameroun', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}