Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00772720
Status:
UNKNOWN
Last Update Posted:
2010-03-31
First Post:
2008-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-30', 'studyFirstSubmitDate': '2008-10-14', 'studyFirstSubmitQcDate': '2008-10-14', 'lastUpdatePostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood levels of total cholesterol', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Changes in HDL, LDL and triglycerides', 'timeFrame': '7 days'}, {'measure': 'Oral glucose tolerance test', 'timeFrame': '7 days'}, {'measure': 'Mitochondrial DNA levels', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male.\n2. age between 18 and 45.\n3. BMI between 19 and 25 kg/m2\n4. Normal physical exam.\n5. Blood analysis without relevant findings.\n6. Negative serology for hepatitis B, Hepatitis C and HIV.\n7. Negative urine test for abuse drugs.\n\nExclusion Criteria:\n\n1. Severe psychiatric disease.\n2. Dyslipemia.\n3. Alcohol intake above 30 g per day.\n4. Smokers\n5. Xanthine intake above 5 coffee cup -equivalents per day\n6. Use of any drugs in the last month\n7. Participation in other trials in the last 3 months\n8. Diseases capable to modify drug ADME\n9. Drug allergy'}, 'identificationModule': {'nctId': 'NCT00772720', 'acronym': 'RALMET-VOLHCB', 'briefTitle': 'Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'RALMET-VOLHCB'}, 'secondaryIdInfos': [{'id': 'EUDRACT #: 2008- 003288-37'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': 'raltegravir 400 mg BID for 7 days'}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo BID for 7 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esteban Martinez, MD', 'role': 'CONTACT', 'email': 'esteban@fundsoriano.es', 'phone': '0034932275400', 'phoneExt': '3310'}], 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jose M Gatell', 'oldOrganization': 'Hospital Clinic'}}}}