Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-22 @ 1:41 PM
Study NCT ID:
NCT00122603
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
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': 'C426859', 'term': 'fosamprenavir'}, {'id': 'D019258', 'term': 'Saquinavir'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2005-07-19', 'studyFirstSubmitQcDate': '2005-07-20', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment'}], 'secondaryOutcomes': [{'measure': 'Safety of protease inhibitors'}, {'measure': 'Percentage of patients with viral load below 400 copies/ml at week 16 (W16)'}, {'measure': 'Body mass index (BMI)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Protease Inhibitors', 'HIV infections', 'Atazanavir', 'Saquinavir', 'Fosamprenavir', 'ritonavir', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '19420019', 'type': 'DERIVED', 'citation': 'Landman R, Capitant C, Descamps D, Chazallon C, Peytavin G, Katlama C, Pialoux G, Bentata M, Brun-Vezinet F, Aboulker JP, Yeni P; ANRS 127 Study Group. Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. J Antimicrob Chemother. 2009 Jul;64(1):118-25. doi: 10.1093/jac/dkp146. Epub 2009 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.', 'detailedDescription': 'The purpose of this randomized, open-label study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.\n\nPatients with CD4 cell counts over or equal to 200/mm3, HIV viral load between 10,000 and 750,000 copies per milliliter, and wild-type genotype at baseline will be eligible. This multicenter study will enroll 60 patients (n=30 in each group). The planned duration of the study is 48 weeks from the enrolment of the last subject.\n\nThe primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.\n\nThe primary safety endpoint will be treatment interruptions because of adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Protease inhibitor naive patients\n* Wild type genotype\n* CD4 greater than 200/mm3\n* Viral load between 10,000 copies/ml and 750,000 copies/ml\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy; breast feeding\n* Antiretroviral (ARV) pretreated patients\n* Hyperlipidemic treatment\n* Evolutive disease'}, 'identificationModule': {'nctId': 'NCT00122603', 'briefTitle': 'Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Efficacy and Safety of Regimens Restricted to a Combination of Two Boosted Protease Inhibitors as Potent Antiretroviral Therapy in HIV-1 Infected Patients. ANRS 127 2IP', 'orgStudyIdInfo': {'id': '2005-003470-20'}, 'secondaryIdInfos': [{'id': 'ANRS 127 2 IP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Atazanavir + Fosamprenavir + ritonavir', 'interventionNames': ['Drug: Fosamprenavir']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'Atazanavir + saquinavir + ritonavir', 'interventionNames': ['Drug: Saquinavir']}], 'interventions': [{'name': 'Fosamprenavir', 'type': 'DRUG', 'description': 'ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)', 'armGroupLabels': ['Group 1']}, {'name': 'Saquinavir', 'type': 'DRUG', 'description': 'ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Roland Landman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Bichat SMIT A Paris'}, {'name': 'Jean Pierre Aboulker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inserm SC10'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}