Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00884858
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2009-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects
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': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2009-04-20', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.', 'timeFrame': '3 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'CD4', 'INR', 'HIV-1 infection', 'extreme immunological compromission', 'treatment experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '24244635', 'type': 'DERIVED', 'citation': "Rusconi S, Vitiello P, Adorni F, Colella E, Foca E, Capetti A, Meraviglia P, Abeli C, Bonora S, D'Annunzio M, Di Biagio A, Di Pietro M, Butini L, Orofino G, Colafigli M, d'Ettorre G, Francisci D, Parruti G, Soria A, Buonomini AR, Tommasi C, Mosti S, Bai F, Di Nardo Stuppino S, Morosi M, Montano M, Tau P, Merlini E, Marchetti G. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial. PLoS One. 2013 Nov 14;8(11):e80157. doi: 10.1371/journal.pone.0080157. eCollection 2013."}]}, 'descriptionModule': {'briefSummary': 'Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed.\n\nAlthough the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.\n\nBoth T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.\n\nAnother fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.\n\nWith this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.', 'detailedDescription': 'Objectives:\n\n* Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells \\< 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.\n* Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.\n* Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.\n\nDesign:\n\nThis will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells \\< 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 18\n* HIV-Abs positivity detected by ELISA and confirmed by Western-Blot\n* CD4 lymphocytes \\< 200/uL and/or CD4 recovery \\< 25% after at least 12 months of stable HAART\n* HIV-RNA \\< 50 cp/mL during the last 12 months\n* negative pregnancy test at least 14 days prior to treatment\n* understanding and signing the informed consent\n\nExclusion Criteria:\n\n* allergy/intolerance to the study drug\n* less than 1 year from any treatment with immunomodulatory agents\n* current OIs or neoplasms\n* current CVD or EKG abnormalities\n* current respiratory tract diseases or COPD\n* treatment with steroids within 4 weeks from treatment beginning\n* suspect of autoimmune disorder or chronic inflammatory disease\n* active IVDUs or alcohol addicts\n* AST and ALT \\> 2.5 ULD\n* serum creatinine \\> 1.5 ULD\n* ANC \\< 1000/uL\n* hemoglobin \\< 10 g/dL\n* platelets \\< 75.000/uL\n* reticulocytes \\> 2%\n* Karnofsky score \\< 50'}, 'identificationModule': {'nctId': 'NCT00884858', 'briefTitle': 'Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects', 'organization': {'class': 'OTHER', 'fullName': 'ASST Fatebenefratelli Sacco'}, 'officialTitle': 'Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.', 'orgStudyIdInfo': {'id': 'HLS/MVC01/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maraviroc', 'description': 'Subjects in this group will add Maraviroc to their current HAART.', 'interventionNames': ['Drug: Maraviroc']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Subjects in this group will continue their current HAART without adding Maraviroc.'}], 'interventions': [{'name': 'Maraviroc', 'type': 'DRUG', 'otherNames': ['Maraviroc brand name in the EC is Celsentri.'], 'description': 'Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.', 'armGroupLabels': ['Maraviroc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Torrette Di Ancona', 'state': 'AN', 'country': 'Italy', 'facility': 'Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria'}, {'zip': '70124', 'city': 'Bari', 'state': 'BA', 'country': 'Italy', 'facility': "Clinica di Malattie Infettive, Policlinico, Universita' degli Studi", 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '25125', 'city': 'Brescia', 'state': 'BS', 'country': 'Italy', 'facility': 'Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '50011', 'city': 'Antella', 'state': 'FI', 'country': 'Italy', 'facility': 'Divisione di Malattie Infettive, Ospedale S. Maria Annunziata', 'geoPoint': {'lat': 43.72774, 'lon': 11.32233}}, {'zip': '16132', 'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'facility': 'Clinica di Malattie Infettive, Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20052', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'facility': 'Divisione di Malattie Infettive, Ospedale San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20124', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20157', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20157', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41100', 'city': 'Modena', 'state': 'MO', 'country': 'Italy', 'facility': 'Clinica delle Malattie Infettive, Policlinico Universitario', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Napoli', 'country': 'Italy', 'facility': "Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno", 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '65100', 'city': 'Pescara', 'state': 'PE', 'country': 'Italy', 'facility': 'U.O. Malattie Infettive, Ospedale S. Spirito', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '06126', 'city': 'Perugia', 'state': 'PG', 'country': 'Italy', 'facility': 'Clinica delle Malattie Infettive, Policlinico Monteluce', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '00133', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Clinica delle Malattie Infettive, Policlinico "Tor Vergata"', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00149', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00149', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00161', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'U.O. Malattie Infettive, Azienda Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10149', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Stefano Rusconi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Universita' degli Studi di Milano, Italy"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Fatebenefratelli Sacco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher/Aggregate professor in infectious diseases', 'investigatorFullName': 'Stefano Rusconi', 'investigatorAffiliation': 'ASST Fatebenefratelli Sacco'}}}}