Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-29 @ 8:54 AM
Study NCT ID:
NCT03747003
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gonadal Function in Young to Middle Aged HIV-infected Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D005058', 'term': 'Eunuchism'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample for hormonal assay'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum total testosterone', 'timeFrame': 'Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry', 'description': 'From blood sample - unit of measurement ng/dL'}, {'measure': 'Serum total testosterone', 'timeFrame': 'Assessed only once at the moment of enrollment with chemiluminiscent immunoassay', 'description': 'From blood sample - unit of measurement ng/dL'}], 'secondaryOutcomes': [{'measure': 'Serum free testosterone', 'timeFrame': 'Calculated only once at the moment of enrollment', 'description': 'Calculated formula (Vermeulen equation)'}, {'measure': 'Score at IIEF questionnaire', 'timeFrame': 'Assessed only once at the moment of enrollment', 'description': 'Total score at erectile function domain of IIEF-15 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus', 'Hypogonadism, Male', 'Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.', 'detailedDescription': 'The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of Young-to-Middle Aged HIV-infected Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male gender\n* Age 18-50 years\n* HIV-infection\n* Ongoing Highly Active Antiretroviral Therapy\n\nExclusion Criteria:\n\n* Previous treatment with androgens, anti-androgens\n* Severe liver insufficiency\n* Severe renal insufficiency'}, 'identificationModule': {'nctId': 'NCT03747003', 'briefTitle': 'Gonadal Function in Young to Middle Aged HIV-infected Men', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Modena'}, 'officialTitle': 'Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay', 'orgStudyIdInfo': {'id': '15/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-infected male patients', 'description': 'Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided', 'interventionNames': ['Other: No intervention is provided']}], 'interventions': [{'name': 'No intervention is provided', 'type': 'OTHER', 'description': 'No intervention is provided', 'armGroupLabels': ['HIV-infected male patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliero - Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vincenzo Rochira', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Modena'}}}}