Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-04-06 @ 12:50 AM
Study NCT ID:
NCT00657761
Status:
COMPLETED
Last Update Posted:
2008-04-14
First Post:
2008-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Enfuvirtide in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077560', 'term': 'Enfuvirtide'}], 'ancestors': [{'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015700', 'term': 'HIV Envelope Protein gp41'}, {'id': 'D014760', 'term': 'Viral Fusion Proteins'}, {'id': 'D050576', 'term': 'Membrane Fusion Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D015488', 'term': 'HIV Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D054299', 'term': 'env Gene Products, Human Immunodeficiency Virus'}, {'id': 'D015686', 'term': 'Gene Products, env'}, {'id': 'D012191', 'term': 'Retroviridae Proteins'}, {'id': 'D054298', 'term': 'Human Immunodeficiency Virus Proteins'}, {'id': 'D014759', 'term': 'Viral Envelope Proteins'}, {'id': 'D015678', 'term': 'Viral Structural Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-08', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-04-08', 'lastUpdatePostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fasting plasma total cholesterol', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males\n* BMI between 19-24.9 kg/m2\n* No active concomitant clinical conditions\n* Negative HIV, HBV and HCV serologies\n* Negative abuse drug urine test\n\nExclusion Criteria:\n\n* Prior psychiatric illness\n* Prior dyslipemia\n* Alcohol consumption \\> 30g/day\n* Caffeine consumption \\> 5 units/day\n* Current smoker\n* Known drug allergies\n* Participation in other drug trials in the previous 3 months\n* No medications in the previous 30 days'}, 'identificationModule': {'nctId': 'NCT00657761', 'briefTitle': 'Metabolic Effects of Enfuvirtide in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ENF/01FD-05/UF1'}, 'secondaryIdInfos': [{'id': 'EudraCT #: 2005-002018-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline solution 0.9% sc/12h for 7 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Enfuvirtide', 'description': 'Enfuvirtide 90 mg/12h sc for 7 days', 'interventionNames': ['Drug: Enfuvirtide']}], 'interventions': [{'name': 'Enfuvirtide', 'type': 'DRUG', 'description': '90 mg/12h sc for 7 days', 'armGroupLabels': ['Enfuvirtide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% saline solution/12h sc for 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Neus Riba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jose M Gatell', 'oldOrganization': 'Hospital Clinic, Barcelona'}}}}