Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT03993093
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2019-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D007896', 'term': 'Leishmaniasis'}, {'id': 'D014123', 'term': 'Toxoplasmosis'}, {'id': 'D009894', 'term': 'Opportunistic 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'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003048', 'term': 'Coccidiosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018791', 'term': 'CD4 Lymphocyte Count'}], 'ancestors': [{'id': 'D018655', 'term': 'Lymphocyte Count'}, {'id': 'D007958', 'term': 'Leukocyte Count'}, {'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of AIDS defining OIs', 'timeFrame': 'Six months', 'description': 'Calculate number of total HIV patients with or without opportunistic infections (n). Again calculate no of HIV patients with opportunistic infections (n1). Then calculate prevalence of HIV +ve patients with opportunistic infections by applying formula n1/n x100.'}], 'secondaryOutcomes': [{'measure': 'Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs', 'timeFrame': 'Six months', 'description': 'Find out CD4 cell counts (cells /μL) of HIV patients with CD4 cell counts (cells/μL) of HIV patients without OIs. By calculating mean/SD of CD4 cells in both groups, comparison by chi square test would be done.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Opportunistic infection', 'CD4+ T cells', 'AIDS defining condition'], 'conditions': ['HIV Infections', 'Tuberculosis', 'Candidiasis, Esophageal', 'Cryptococcosis', 'Leishmaniasis', 'Toxoplasmosis']}, 'descriptionModule': {'briefSummary': 'HIV patients are likely to suffer from opportunistic infections, in absence of highly active retroviral therapy. This happens due to lack of awareness of HIV status among patients or unresponsive to anti retroviral drugs. This study is for the prevalence of AIDS defining OIs among treatment naive HIV patients.', 'detailedDescription': 'Oppotunistic infections (OIs) happen in persons with weakened immune system. HIV patients, who remain untreated due to lack of knowledge of existing HIV infections, often get OIs. HIV patients with AIDS defining OIs fall into stage 3 of HIV illness. Prevalence of OIs in resource poor settings are tuberculosis (pulmonary and extra pulmonary), toxoplasmosis, cryptococcosis, and oesophageal candidiasis. There are a few data to show AIDS defining OIs in treatment naïve HIV patients. Incidence of OIs among HIV patients in United States, and Canada between 2000 to 2019 was 9%. Leading OIs were peumocystis Jiroveci, oesophageal candidiasis and disseminated MAC or M. kansassi.\n\nMinimal diagnoses at poor settings can be made by observation of symptoms, use of microscope, imaging and diagnostic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Antiretroviral treatment naive HIV patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• HAART naïve HIV patient\n\nExclusion Criteria:\n\n* Patients died during screening\n* Transferred in HIV patients'}, 'identificationModule': {'nctId': 'NCT03993093', 'acronym': 'ADC', 'briefTitle': 'Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre', 'organization': {'class': 'INDIV', 'fullName': 'Singh, Ranjan Kumar, M.D.'}, 'officialTitle': 'AIDS Defining Opportunistic Infections in Naive HIV Cases', 'orgStudyIdInfo': {'id': 'SinghRK1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV with OIs', 'description': 'Treatment naive HIV patients with OIs', 'interventionNames': ['Other: CD4 cell count']}], 'interventions': [{'name': 'CD4 cell count', 'type': 'OTHER', 'description': 'CD4 cell count from treatment naive HIV patients', 'armGroupLabels': ['HIV with OIs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '851204', 'city': 'Khagaria', 'state': 'Bihar', 'country': 'India', 'facility': 'ART centre, Sadar Hospital', 'geoPoint': {'lat': 25.5022, 'lon': 86.46708}}], 'overallOfficials': [{'name': 'Ranjan K Singh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singh, Ranjan Kumar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singh, Ranjan Kumar, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, cum nodal officer, ART centre Khagaria', 'investigatorFullName': 'Ranjan Kumar Singh', 'investigatorAffiliation': 'Singh, Ranjan Kumar, M.D.'}}}}