Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00808002
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2008-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine
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': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2008-12-12', 'studyFirstSubmitQcDate': '2008-12-12', 'lastUpdatePostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.', 'timeFrame': 'BL, W2, W4, W12, W24, W48'}], 'secondaryOutcomes': [{'measure': 'Decay of residual HIV-1 replication under maraviroc intensification assessed by an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL.', 'timeFrame': 'BL, W2, W4, W8, W12, W24, W36, W48'}, {'measure': 'Blips during the study (viral load >50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls).', 'timeFrame': 'From Baseline to W48'}, {'measure': 'HIV-1 RNA below 50 copies/mL at 48 weeks.', 'timeFrame': 'W48'}, {'measure': 'Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48.', 'timeFrame': 'BL, W4, W12, W24, W48, W60, W72'}, {'measure': 'Relationship between maraviroc and/or raltegravir plasma concentrations and change in the slope of decay of integrated viral DNA in PBMCs', 'timeFrame': 'W12, W24, W48'}, {'measure': 'HIV-1 specific CTL responses', 'timeFrame': 'BL, W24, W48, W60, W72'}, {'measure': 'Plasmatic inflammation biomarkers', 'timeFrame': 'BL, W2, W4, W12, W48, W60'}, {'measure': 'RNA, DNA and viral p24 associated to cells in ileum biopsy and PBMC', 'timeFrame': 'W48'}, {'measure': 'Lymphocyte activation marker HLADR+CD38+ in ileum biopsy and PBMC', 'timeFrame': 'W48'}, {'measure': 'Fibrosis markers in ileum biopsy and PBMC', 'timeFrame': 'W48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Maraviroc', 'CCR5 antagonists', 'Primary HIV Infection', 'HIV-1 reservoir', 'eradication', 'treatment naive'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.\n\nThis could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.', 'detailedDescription': 'A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.\n\nThe majority of the viruses in the latent reservoir use CCR5 receptor during entry.\n\nMore recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.\n\nIn contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.\n\nMaraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV-1 infected adults (\\>=18 years old).\n2. No previous antiretroviral therapy for more than 2 weeks.\n3. HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.\n4. CCR5-tropism confirmed at screening.\n5. Voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy or fertile women willing to be pregnant.\n2. Active substance abuse or major psychiatric disease.\n3. Presence of NRTI mutations in the screening genotype.'}, 'identificationModule': {'nctId': 'NCT00808002', 'briefTitle': 'Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine.', 'orgStudyIdInfo': {'id': 'MARAVIBOOST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'From Baseline to Week48: Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID From W48 to W72: Raltegravir BID + Tenofovir/Emtricitabine QD', 'interventionNames': ['Drug: Raltegravir', 'Drug: Maraviroc', 'Drug: Tenofovir/Emtricitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine', 'interventionNames': ['Drug: Raltegravir', 'Drug: Tenofovir/Emtricitabine']}], 'interventions': [{'name': 'Raltegravir', 'type': 'DRUG', 'description': 'Raltegravir 400 mg every 12 hours', 'armGroupLabels': ['1', '2']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 300 mg every 12 hours', 'armGroupLabels': ['1']}, {'name': 'Tenofovir/Emtricitabine', 'type': 'DRUG', 'description': 'Tenofovir/Emtricitabine 300/200 mg every 24 hours', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08916', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Bonaventura Clotet, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LLuita contra la SIDA Foundation-HIV Unit'}, {'name': 'Josep Mª Llibre, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LLuita contra la SIDA Foundation-HIV Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Bonaventura Clotet', 'investigatorFullName': 'Dr . BONAVENTURA CLOTET', 'investigatorAffiliation': 'Germans Trias i Pujol Hospital'}}}}