Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00820118
Status:
COMPLETED
Last Update Posted:
2012-05-23
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
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': 'D000097042', 'term': 'Treatment Interruption'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C492871', 'term': 'abacavir, lamivudine drug combination'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-22', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study.', 'timeFrame': 'M21 and M24'}], 'secondaryOutcomes': [{'measure': 'proportion of patients following the strategy of the trial and with AIDS related and non AIDS-related (cardiovascular, renal, hepatic, infectious, cancerous) serious clinical event', 'timeFrame': 'M12 and M24'}, {'measure': 'number, type and time to AIDS and non AIDS-related serious clinical events', 'timeFrame': 'from week 0 to M24'}, {'measure': 'number, type and time to clinical and biological events (whatever the grade of severity)', 'timeFrame': 'from week 0 to M24'}, {'measure': 'existence and nature of HIV genotypic mutations associated with antiretroviral resistance', 'timeFrame': 'M9 and M24 and at any time visit in case of failure'}, {'measure': 'proportion of patients having followed the strategy of the trial', 'timeFrame': 'from week 0 to M24'}, {'measure': 'evolution of HIV RNA and HIV DNA throughout the study', 'timeFrame': 'from week 0 to M24 for RNA and each 6 months for DNA'}, {'measure': 'Quality of life and observance (questionnaires)', 'timeFrame': 'QL each 6 months, observance at M1, M6, M13 and M18'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ANTIRETROVIRAL THERAPY', 'STRUCTURED TREATMENT INTERRUPTIONS', 'treatment naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '26568566', 'type': 'DERIVED', 'citation': 'Piroth L, Moinot L, Yeni P, Avettand-Fenoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chene G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14.'}], 'seeAlsoLinks': [{'url': 'http://www.anrs.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult confirmed HIV-1 infection\n* no previous treatment with antiretroviral drugs or interleukin-2\n* CD4 count ≥ 500/mm3\n* no active opportunistic infection\n* written informed consent\n\nExclusion Criteria:\n\n* non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years\n* HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy\n* previous history of cerebrovascular accident or coronary heart disease, splenectomy\n* previous CD4 count \\< 400/mm3\n* CD4 percentage \\< 15%\n* hemoglobin \\< 8 g/dl, neutrophils \\< 750/mm3, platelets \\< 100.000/mm3, creatinine clearance \\< 50 ml/mn, AST or ALT or total bilirubin \\> 3 ULN'}, 'identificationModule': {'nctId': 'NCT00820118', 'acronym': 'TIPI', 'briefTitle': 'Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3', 'orgStudyIdInfo': {'id': 'ANRS 141 TIPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent treatment', 'description': '6 months on antiretroviral treatment and 6 months off treatment', 'interventionNames': ['Drug: Structured treatment interruption']}], 'interventions': [{'name': 'Structured treatment interruption', 'type': 'DRUG', 'otherNames': ['Reyataz', 'Truvada', 'Kivexa', 'Treatment interruption', 'STI'], 'description': 'The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir\n\nUsual dosage recommended :\n\n* atazanavir : 300 mg/d\n* ritonavir : 100 mg/d\n* abacavir 600 mg and lamivudine 300 mg : once a day\n* tenofovir 245 mg and emtricitabine 200 mg : once a day', 'armGroupLabels': ['Intermittent treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Services maladies infectieuses et tropicales CHU', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Lionel PIROTH, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de Dijon, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}