Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00739258
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2008-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D005873', 'term': 'Giardiasis'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D013587', 'term': 'Syphilis'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], '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': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2008-08-19', 'studyFirstSubmitQcDate': '2008-08-20', 'lastUpdatePostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-infected person', 'Entamoeba', 'Cryptosporidium', 'Giardia', 'ELISA', 'PCR', 'IDU', 'Gonorrhea', 'Chlamydial trachomatis', 'Syphilis', 'Genital warts', 'Herpes simplex virus'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'It is difficult to detect the intestinal protozoal infections among the HIV-infected persons or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of this study aimed at finding out the appropriate diagnostic methods and the infection rate of the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the HIV-infected persons by using the antigen detection method and biological method. The investigators also tried to analyze the associated HIV infection status and sexual transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital warts and Herpes simplex virus in this study. The study will collect the blood, urine and stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400 intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV infected receiving methadone maintenance treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The samples are obtained from Kaohsiung prison, Kaohsiung women's prison, Pingtung prison and the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of HIV\n* Receiving Methadone Maintenance Treatment\n* intravenous drug user (IDU)'}, 'identificationModule': {'nctId': 'NCT00739258', 'briefTitle': 'Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison and Set up the Notional Halfway Home in Union Area of Medical Facility', 'orgStudyIdInfo': {'id': 'KMUH-IRB-970077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIDU', 'description': 'intravenous drug user (IDU) with HIV infected'}, {'label': 'IDU', 'description': 'intravenous drug user (IDU) without HIV'}, {'label': 'MH', 'description': 'persons receiving methadone maintenance treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaoshing Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}