Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-02-25 @ 3:33 AM
Study NCT ID:
NCT02203461
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2014-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp', 'timeFrame': 'Day 14', 'description': 'Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.'}], 'secondaryOutcomes': [{'measure': 'Changes in metabolic parameters', 'timeFrame': 'Day 14', 'description': 'Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ART, HIV, insulin resistance'], 'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.', 'detailedDescription': 'The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers, age 18-40 years\n* Informed consent and willingness in study participation\n* Birth control during study period\n\nExclusion Criteria:\n\n* Participation in other clinical trials\n* Contraindication or known allergy to study medication\n* Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others\n* Known alcohol or nicotine abuse\n* HIV infection\n* History of pharmaceutical study in the last 4 weeks\n* BMI \\< 18 \\> 25\n* Long-term or regular medication\n* Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder\n* Dependence to study center or coordinator\n* Inmates or psychiatric treatment'}, 'identificationModule': {'nctId': 'NCT02203461', 'briefTitle': 'Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.', 'orgStudyIdInfo': {'id': 'STR-1383--0030-I'}, 'secondaryIdInfos': [{'id': '2014-000359-98', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat', 'interventionNames': ['Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir', 'interventionNames': ['Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Group III', 'description': 'Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir', 'interventionNames': ['Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir']}], 'interventions': [{'name': 'Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat', 'type': 'DRUG', 'otherNames': ['STRIBILD®'], 'description': 'STRIBILD® QD, d1-14', 'armGroupLabels': ['Group I']}, {'name': 'Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['Truvada® / Kaletra®'], 'description': 'Truvada®/ Kaletra® 200/50 mg QD, d1-14', 'armGroupLabels': ['Group II']}, {'name': 'Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir', 'type': 'DRUG', 'otherNames': ['Truvada®/Prezista®/Norvir®'], 'description': 'Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Klinikum rechts der Isar (TUM)', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Christoph D Spinner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'MUC Research GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}