Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 8:45 AM
Study NCT ID:
NCT01033760
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'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': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'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': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30', 'timeFrame': '30 months'}, {'measure': 'Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24', 'timeFrame': '24 months'}, {'measure': 'Changes in cell-associated HIV-DNA between baseline and M24', 'timeFrame': '24 Months'}, {'measure': 'Evolution of the CD4 and CD8 between D0 and M24', 'timeFrame': '24 months'}, {'measure': 'Tolerability of trial treatments', 'timeFrame': '24 months'}, {'measure': 'Number and type of ARV mutations in virological failures and change in CCR5 tropism', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary HIV-1 infection', 'antiretroviral treatment', 'HIV reservoirs', 'HIV-DNA levels', 'randomized', 'Treatment Naive'], 'conditions': ['HIV-1 Infections']}, 'referencesModule': {'references': [{'pmid': '28708873', 'type': 'DERIVED', 'citation': 'Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.'}, {'pmid': '25701561', 'type': 'DERIVED', 'citation': 'Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.', 'detailedDescription': 'Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.\n\nAfter HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).\n\nWe hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute or primary HIV-1 infection\n* Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.\n* Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and \\< 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.\n* Symptomatic Primary infection or CD4 \\<500/mm3\n* written informed consent\n* ≥ 18 years old\n\nExclusion Criteria:\n\n* Prior post exposure antiretroviral treatment within six months before enrolment\n* Pregnancy or breast-feeding\n* HIV-2 infection\n* Current malignancy\n* Prothrombin time \\< 50%\n* Creatinine clearance \\< 60 ml/min\n* ASAT, ALAT or bilirubin ≥10\\*N\n* Platelets \\< 25000/mm3'}, 'identificationModule': {'nctId': 'NCT01033760', 'briefTitle': 'Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)', 'orgStudyIdInfo': {'id': '2009-014742-28'}, 'secondaryIdInfos': [{'id': 'EudraCT', 'type': 'REGISTRY', 'domain': '2009-014742-28'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arm 1', 'description': 'darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir', 'interventionNames': ['Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'arm 2', 'description': 'darunavir, ritonavir, emtricitabine/tenofovir', 'interventionNames': ['Drug: darunavir; ritonavir; emtricitabine/tenofovir']}], 'interventions': [{'name': 'raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine', 'type': 'DRUG', 'description': 'raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.', 'armGroupLabels': ['arm 1']}, {'name': 'darunavir; ritonavir; emtricitabine/tenofovir', 'type': 'DRUG', 'description': 'darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.', 'armGroupLabels': ['arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Hôpital Gustave Dron', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Antoine CHERET, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tourcoing Hospital'}, {'name': 'Caroline LASCOUX-COMBE, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Louis Hospital, Paris'}, {'name': 'Laurence MEYER, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Methodologist, INSERM U1018'}, {'name': 'Bruno HOEN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Jacques Hospital, CHU Besançon'}, {'name': 'Isabelle RAVAUX, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Conception Hospital, Marseille'}, {'name': 'Christine ROUZIOUX, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virology Investigator, Necker Hospital Paris'}, {'name': 'Alain VENET, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunology Investigator, INSERM U1012 Bicêtre'}, {'name': 'Daniel OLIVE, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunology Investigator, Cancerology Institut Marseille'}, {'name': 'Gianfranco PANCINO, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunology Investigator, Pasteur Institut Paris'}, {'name': 'Brigitte AUTRAN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunology Investiigator, INSERM U543 Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Janssen-Cilag Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}