Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 5:52 PM
Study NCT ID:
NCT00615134
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2008-01-30', 'studyFirstSubmitQcDate': '2008-02-13', 'lastUpdatePostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with plasma viral load <50 copies/mL', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': "CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.", 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'keywords': ['treatment experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon\n\n\\+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.\n\nc. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* HIV-1 infection, with virologic failure;\n* on same stable HAART for \\>4 weeks, with viral load \\>1000 RNA copies/mL;\n* Fuzeon-naive.\n\nExclusion Criteria:\n\n* coinfection with HIV-2;\n* active opportunistic infection in 4 weeks prior to screening;\n* cirrhosis or severe liver failure;\n* severe renal disease.'}, 'identificationModule': {'nctId': 'NCT00615134', 'briefTitle': 'INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.', 'orgStudyIdInfo': {'id': 'ML21287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: enfuvirtide [Fuzeon]', 'Drug: Optimized background ARV therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Optimized background ARV therapy']}], 'interventions': [{'name': 'enfuvirtide [Fuzeon]', 'type': 'DRUG', 'description': '90mg sc bid', 'armGroupLabels': ['1']}, {'name': 'Optimized background ARV therapy', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93600', 'city': 'Aulnay-sous-Bois', 'country': 'France', 'geoPoint': {'lat': 48.93814, 'lon': 2.49402}}, {'zip': '97100', 'city': 'Basse-terre', 'country': 'France'}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '62321', 'city': 'Boulogne', 'country': 'France', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '97261', 'city': 'Fort-de-france', 'country': 'France'}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '91275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '92309', 'city': 'Levallois-Perret', 'country': 'France', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13006', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44035', 'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '97159', 'city': 'Pointe à Pitre', 'country': 'France', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '95303', 'city': 'Pontoise', 'country': 'France', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '73031', 'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '97400', 'city': 'Saint-Denis', 'country': 'France', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97448', 'city': 'Saint-Pierre', 'country': 'France', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}