Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT00946595
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2009-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients
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': 'C098320', 'term': 'efavirenz'}, {'id': 'D000068257', 'term': 'Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-23', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients without treatment failure at Week 96', 'timeFrame': 'Week 96'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96', 'timeFrame': 'Week 96'}, {'measure': 'Proportion of patients with plasma HIV-1 RNA below 400 cp/mL at all time points during the trial', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Evolution of CD4 cell count between Week 0 and Week 96', 'timeFrame': 'Between Week 0 and Week 96'}, {'measure': 'Evaluation of treatment adherence', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Evaluation of treatment tolerance', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Number and type of new resistance mutations in case of two successive plasma HIV-1 RNA ≥ 400 cp/mL', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Proportion of patients with loss of future drug options', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Evaluation of quality of life assessments', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, without interference in daily functioning or functioning complaint between Week 0 and Week 96', 'timeFrame': 'Between Week 0 and Week 96'}, {'measure': 'Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, with interference in daily functioning or functioning complaint between Week 0 and Week 96', 'timeFrame': 'Between Week 0 and Week 96'}, {'measure': 'Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients', 'timeFrame': 'Between Week 0 and Week 96'}, {'measure': 'Analysis of the determinants of the durability of the virological response', 'timeFrame': 'From Week 0 to Week 96'}, {'measure': 'Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant', 'timeFrame': 'From Week 0 to Week 96'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Undetectable', 'HIV infections', 'Monotherapy', 'Lopinavir/ritonavir', 'Protease inhibitor', 'Treatment experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '30968368', 'type': 'DERIVED', 'citation': 'Garay OU, Nishimwe ML, Bousmah MA, Janah A, Girard PM, Chene G, Moinot L, Sagaon-Teyssier L, Meynard JL, Spire B, Boyer S. Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM). Pharmacoecon Open. 2019 Dec;3(4):505-515. doi: 10.1007/s41669-019-0130-7.'}, {'pmid': '29767684', 'type': 'DERIVED', 'citation': 'Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.'}], 'seeAlsoLinks': [{'url': 'http://www.anrs.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).', 'detailedDescription': 'Today, one of the challenges of HIV treatment is to overcome side effects and toxicity of long term antiretroviral therapy. A promising approach may be the simplification of treatment maintenance strategies, sparing certain antiretroviral drug classes. This is a two-year prospective phase II/III, multicenter randomized trial to evaluate the efficacy and tolerance of a lopinavir/ritonavir monotherapy as a maintenance regimen in HIV-infected adults. Enrolled patients must have had stable antiretroviral treatment and HIV-1 RNA below 50 cp/mL over the previous 12 months, and no prior treatment failure. Provided informed consent, 420 patients are randomized in a 1:1 ratio to two open-label treatment groups and receive either lopinavir/r 800/200mg per day or EFV/FTC/TDF 600/200/245 mg per day (fixed dose combination). The main objective is to assess treatment efficacy and tolerance after 2 years. In 80 patients, repeated DEXA measurements are performed during the trial in order to evaluate changes in bone mineral density and in body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed HIV-1 infection\n* Stable antiretroviral treatment over 6 months\n* HIV-1 RNA \\< 50 cp/mL for at least 12 months\n* Lymphocytes CD4+ \\> 200/mm3\n* Lymphocytes CD4+ nadir \\> 100/mm3\n* Absence of prior treatment failure (defined by two successive HIV-1 RNA ≥ 50 cp/mL under NNRTI or PI treatment)\n* Absence of documentation of a mutation conferring NRTI or NNRTI resistance or a primary mutation in the protease gene\n* Written informed consent\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Woman of child bearing potential without efficient contraception\n* Pregnant or breastfeeding woman\n* HBV infection (HbS Ag+)\n* HBC infection requiring specific treatment during the trial\n* Liver cirrhosis Child-Pugh C\n* HIV-1/HIV-2 Co-infection or isolated HIV-2 infection\n* Ongoing interleukin or interferon treatment\n* Co-administration of contraindicated treatments\n* Hypersensibility to efavirenz or lopinavir/r\n* Absolute neutrophil count \\< 750/mm3, hemoglobin \\< 8g/dL, platelets \\< 60.000/mm3, creatinine clearance \\< 50 mL/min, ASAT, ALAT, lipase, alkaline phosphatase or total bilirubin \\> 3 ULN, CD4 nadir \\< 100/mm3.\n* Participation in another clinical trial interfering with the study drug assignment in DREAM\n* Subject under legal guardianship or incapacitation'}, 'identificationModule': {'nctId': 'NCT00946595', 'acronym': 'ANRS 140 DREAM', 'briefTitle': 'Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL', 'orgStudyIdInfo': {'id': '2009-009776-13'}, 'secondaryIdInfos': [{'id': 'ANRS 140 DREAM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'efavirenz/emtricitabin/tenofovir', 'interventionNames': ['Drug: efavirenz/emtricitabin/tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'lopinavir/ritonavir', 'interventionNames': ['Drug: lopinavir/ritonavir']}], 'interventions': [{'name': 'efavirenz/emtricitabin/tenofovir', 'type': 'DRUG', 'otherNames': ['Atripla'], 'description': '1x600/200/245 mg per day (one tablet) between W0 et W98', 'armGroupLabels': ['efavirenz/emtricitabin/tenofovir']}, {'name': 'lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['Kaletra'], 'description': '4 x 200/50 mg (4 tablets) once a day between W0 and W98', 'armGroupLabels': ['lopinavir/ritonavir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72012', 'city': 'Paris', 'country': 'France', 'facility': 'Service des maladies infectieuses et tropicales Hopital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}