Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT00849160
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2009-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.
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': 'D000069454', 'term': 'Darunavir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2009-02-20', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Undetectable viral load ( < 50 copies/ml)', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with undetectable viral load under 50 copies/ml', 'timeFrame': 'All visits'}, {'measure': 'Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.', 'timeFrame': 'All visits'}, {'measure': 'CD4 lymphocytes count and evolution', 'timeFrame': 'All visits'}, {'measure': 'Lipids balance evolution', 'timeFrame': 'All visits'}, {'measure': 'Treatment tolerance', 'timeFrame': 'All visits'}, {'measure': 'Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.', 'timeFrame': 'All visits'}, {'measure': 'Spermatic viral load (sub-study concerning 15 patients)', 'timeFrame': 'Day 0 and Week 48'}, {'measure': 'Pharmacologic sub-studies', 'timeFrame': 'All visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV-1 Infection', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.\n\nThus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected patients\n* Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month\n* At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months\n* Naiive from darunavir\n* Free from any opportunistic infection\n* Creatinin \\< 3N\n* ASAT \\& ALAT \\< 5N\n* Haemoglobin \\> 7 g/dl\n* Platelets \\> 50 000/mm3\n* Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships\n* Signed informed consent\n\nExclusion Criteria:\n\n* HIV-2 infected patients\n* Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)\n* Patients with a documented problem of treatment compliance within the last 12 months\n* Ongoing active treatment against any opportunistic infection or tuberculosis\n* Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance\n* Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes\n* Patient already treated with darunavir\n* Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc'}, 'identificationModule': {'nctId': 'NCT00849160', 'acronym': 'RADAR', 'briefTitle': 'Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida"}, 'officialTitle': 'Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.', 'orgStudyIdInfo': {'id': 'CREPATS 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darunavir/r', 'interventionNames': ['Drug: darunavir']}], 'interventions': [{'name': 'darunavir', 'type': 'DRUG', 'description': 'darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment', 'armGroupLabels': ['Darunavir/r']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon - Service des Maladies Infectieuses et Tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jade Ghosn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hsopitalier Universitaire de Bicêtre'}, {'name': 'Christine Katlama, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Groupe Hospitalier Pitié-Salpêtrière'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}