Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-04-11 @ 7:57 AM
Study NCT ID:
NCT02025868
Status:
UNKNOWN
Last Update Posted:
2017-02-17
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
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'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virologic efficacy of the adherence reinforcement intervention', 'timeFrame': 'Week 12', 'description': 'Proportion of patients with plasma viral load \\<400 copies/ml at Week 12 and/or with a decrease in plasma viral load \\>2 log10 copies/ml between inclusion and Week 12'}, {'measure': 'Persistent virologic efficacy of the adherence reinforcement intervention', 'timeFrame': 'Week 64', 'description': 'Proportion of patients with plasma viral load \\<50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16'}, {'measure': 'Virologic efficacy of 3rd-line ART', 'timeFrame': 'Week 64', 'description': 'Proportion of patients with HIV-1 plasma viral load \\<50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART'}], 'secondaryOutcomes': [{'measure': 'Immunological efficacy of the adherence reinforcement intervention', 'timeFrame': 'Week 12', 'description': 'CD4 count evolution between inclusion and Week 12'}, {'measure': 'Immunological efficacy of 3rd-line ART', 'timeFrame': 'Week 64', 'description': 'CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16'}, {'measure': 'Tolerance of 3rd-line ART drugs', 'timeFrame': 'Week 64', 'description': 'Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART'}, {'measure': 'Adherence to 3rd-line ART', 'timeFrame': 'Week 64', 'description': '3rd-line Medication Possession Ratio between Week 16 and Week 64'}, {'measure': 'Resistance to 1st and 2nd-line antiretroviral drugs', 'timeFrame': 'Week 12', 'description': 'Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12'}, {'measure': 'Resistance to 1st, 2nd and 3rd-line antiretroviral drugs', 'timeFrame': 'Week 64', 'description': 'Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64'}, {'measure': 'Plasma antiretroviral drugs concentration', 'timeFrame': 'Week 12', 'description': 'Plasma antiretroviral drugs concentration at Week 12'}, {'measure': 'Plasma antiretroviral drugs concentration', 'timeFrame': 'Week 64', 'description': 'Plasma antiretroviral drugs concentration at Week 64'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Africa', 'Antiretroviral Treatment', 'Adherence reinforcement', 'Third line ART', 'Second line ART', 'Virologic failure', 'Adults'], 'conditions': ['HIV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://anrs.fr/', 'label': 'Sponsor site'}, {'url': 'http://www.mereva.net/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.\n\nHIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA \\>1000 copies/ml) will be recruited and followed in two phases:\n\n* First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;\n* Second, a 48-week phase, during which:\n\n * Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;\n * Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.\n\nGenotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA \\<50 copies/ml at 64 weeks.", 'detailedDescription': 'Main objective\n\nTo estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART:\n\n1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;\n2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ;\n3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen.\n\nNumber of participants : 200\n\nMain outcome :\n\n* At 12 weeks : Proportion of patients with a plasma HIV-1 RNA \\<400 copies/ml and/or with a decrease in plasma HIV-1 RNA \\>2 log10 copies/ml between inclusion and 12 weeks;\n* At 64 weeks : proportion of patients with a plasma HIV-1 RNA \\<50 copies/ml.\n\nInclusion criteria:\n\n* Age \\>18 years\n* Documented HIV-1 infection.\n* History of failing a NNRTI-based 1st-line ART\n* Current PI-based 2nd-line ART \\>6 months\n* Plasma HIV-1 RNA \\>1000 copies/ml\n* Signed informed consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Documented HIV-1 infection\n* History of failing a NNRTI-based 1st-line ART\n* Current PI-based 2nd-line ART \\>6 months\n* Plasma HIV-1 RNA \\>1000 copies/ml\n* Signed informed consent\n\nExclusion Criteria:\n\n* HIV-2 infection\n* Any Severe clinical event under exploration\n* History of treatment including darunavir or raltegravir.'}, 'identificationModule': {'nctId': 'NCT02025868', 'acronym': 'THILAO', 'briefTitle': 'Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.', 'orgStudyIdInfo': {'id': 'ANRS 12269 THILAO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adherence reinforcement before switch to 3rd-line ART', 'interventionNames': ['Behavioral: adherence reinforcement', 'Drug: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)']}], 'interventions': [{'name': 'adherence reinforcement', 'type': 'BEHAVIORAL', 'description': 'Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.', 'armGroupLabels': ['Adherence reinforcement before switch to 3rd-line ART']}, {'name': 'Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)', 'type': 'DRUG', 'description': 'Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.\n\nThird-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)', 'armGroupLabels': ['Adherence reinforcement before switch to 3rd-line ART']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo-Dioulasso', 'country': 'Burkina Faso', 'facility': 'CHU Sourô Sanou', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}, {'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'CHU Yalgado Ouedraogo', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Centre de Prise en Charge et de Formation (CePReF), Association ACONDA', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Service des Maladies Infectieuses et Tropicales (SMIT)', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Bamako', 'country': 'Mali', 'facility': "Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)", 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Bamako', 'country': 'Mali', 'facility': 'CHU Point G', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Dakar', 'country': 'Senegal', 'facility': 'CHU Fann', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Serge P. Eholie, MD, MSc, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire"}, {'name': 'Roland Landman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France"}, {'name': 'Xavier Anglaret, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inserm 897, University of Bordeaux, France'}, {'name': 'Pierre-Marie Girard, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Infectious Diseases Department, University Hospital Saint Antoine, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}