Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-04-16 @ 4:03 PM
Study NCT ID:
NCT02665559
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'HIV-DNA quantification on PBMCs sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testosteron Level', 'timeFrame': 'up to 1 year', 'description': 'Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Hypogonadism', 'Metabolic Syndrom', 'Reservoirs', 'Osteodensitometry', 'Erectil dysfonction', 'Depression'], 'conditions': ['Hypogonadism', 'HIV']}, 'descriptionModule': {'briefSummary': "Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life.\n\nChronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand, abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular invasion by lymphoma or Kaposi's syndromes have also been described.\n\nThe advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless of the antiretroviral therapy and CD4-T cell count.\n\nNo study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients in the European population.", 'detailedDescription': 'Assess the prevalence and clinical, biological, paraclinical and therapeutic factors associated with primary or secondary hypogonadism in HIV treated and virologically suppressed patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected men, treated by cART and presenting an undetectable viral load', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 18-50 years at the inclusion visit\n* Under antiretroviral treatment for more than six months with undetectable viral load (last sample older than four months before the visit of run)\n* Infection by HIV-1 positive (confirmation by a full Western blot or by measurement of plasma HIV RNA prior to the inclusion)\n* Lack of co-infections HBV, HCV (last negative serology older than 6 months before the screening visit inclusion)\n* Consent signed by the patient and the investigator the day of the inclusion and before any examination required by the test (Article L1122-1-1 the Code of Public Health)\n* Patient affiliated or beneficiary of a social security system of the European Community member countries (Article L1121-11 of the Code of Public Health).\n\nExclusion Criteria:\n\n* Infection by HIV-2\n* All stages of cirrhosis\n* Severe renal impairment (creatinine clearance below 30 ml / min)\n* Opportunistic infection during treatment or opportunistic infection in history\n* Neoplastic pathology being processed\n* Taken in the previous 3 months of testosterone and other anabolic agents, antiandrogens, estrogens, glucocorticoids, analog GnRH, growth hormone or human insulin-like growth factor-1 (IGF-1)\n* Pituitary, adrenal or testicular pathologies , treated or not\n* Presence or history of psychotic disorder and / or high suicide risk\n* Refusal to participate\n* No one under safeguard justice\n* Patients participating in another research evaluating other treatments and including an exclusion period ongoing at the inclusion'}, 'identificationModule': {'nctId': 'NCT02665559', 'acronym': 'HYPOG', 'briefTitle': 'Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men', 'organization': {'class': 'OTHER', 'fullName': 'Tourcoing Hospital'}, 'officialTitle': 'Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated With Hypogonadism in HIV + Men', 'orgStudyIdInfo': {'id': 'HYPOGONADISME'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypogonadism group', 'description': 'a cross-sectional and prospective study, in HIV-infected men less than 50 years old, with HIV-RNA ≤ 50 cop/mL under ART who had never presented AIDS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Tourcoing Hospital', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Antoine CHERET, M.D.,PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tourcoing Hospital'}, {'name': 'Armelle PASQUET, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tourcoing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'data are reported on a informatic folder centralized at Tourcoing Hospital with anonymous number for each patient Each patient receive by their own practician the biologics data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tourcoing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}