Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-04-25 @ 8:29 PM
Study NCT ID:
NCT02384967
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with therapeutic success, defined as no virological failure', 'timeFrame': 'Week 48', 'description': 'Virological failure is defined as confirmed VL \\> 50 cp/mL and no change of the strategy'}], 'secondaryOutcomes': [{'measure': 'Proportions of patients with virological failure (confirmed VL > 50 cp/ml)', 'timeFrame': 'Week 48'}, {'measure': 'Proportions of patients with VL < 50 cp/ml', 'timeFrame': 'Week 12, Week 24, Week 36, Week 48'}, {'measure': 'Proportions of patients with VL between 20 and 50 cp/ml', 'timeFrame': 'Week 12, Week 24, Week 36, Week 48'}, {'measure': 'Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48', 'timeFrame': 'Week 12, Week 24, Week 36, Week 48'}, {'measure': 'Change from baseline in blood HIV DNA at week 48', 'timeFrame': 'Week 48'}, {'measure': 'Emerging drug resistance if virological failure', 'timeFrame': 'Week 48'}, {'measure': 'Treatment adherence', 'timeFrame': 'Week 48'}, {'measure': 'Change from baseline in blood lipids at week 24 and week 48', 'timeFrame': 'Week 24 and Week 48'}, {'measure': 'Change from baseline in glucose at week 24 and week 48', 'timeFrame': 'Week 24 and Week 48'}, {'measure': 'Treatment Digestive tolerance', 'timeFrame': 'Week 48'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV INFECTION']}, 'referencesModule': {'references': [{'pmid': '29905808', 'type': 'DERIVED', 'citation': 'Le MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.'}]}, 'descriptionModule': {'briefSummary': 'Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.', 'detailedDescription': 'Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d.\n\nSecondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL \\> 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected adults,\n* age ≥ 18 years,\n* with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),\n* virologically controlled (VL ≤ 50 cp/ml,\n* ≥ 1 year,\n* at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,\n* virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and\n* with no history of virological failure (VL \\> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),\n* no current opportunistic infection,\n* renal clearance ≥ 60 mL/min if tenofovir is used,\n* transaminases (SGOT, SGPT) plasma levels \\< 2N,\n* hemoglobin \\> 11 g/dL,\n* platelets count \\> 150 000/mm3,\n* negative pregnancy test in women with childbearing potential,\n* informed written consent signed by both the investigator and the subject,\n* national insurance scheme (article L1121-11 of the French Public Health code),\n* no participation to any other clinical trial\n\nExclusion Criteria:\n\n* HIV-2 infection,\n* current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,\n* virus genotypically resistant to darunavir and the used NRTIs,\n* history of virological failure (VL \\> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),\n* irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,\n* current pregnancy,\n* current opportunistic infection,\n* associated treatment containing one or more drugs interacting with hepatic cytochromes,\n* any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.'}, 'identificationModule': {'nctId': 'NCT02384967', 'acronym': 'DARULIGHT', 'briefTitle': 'Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment', 'orgStudyIdInfo': {'id': 'ANRS 165 DARULIGHT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darunavir 400mg/d', 'description': 'Tri-therapy containing Darunavir at dose of 400 mg/d.', 'interventionNames': ['Drug: Darunavir']}], 'interventions': [{'name': 'Darunavir', 'type': 'DRUG', 'otherNames': ['Prezista'], 'description': 'to assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.', 'armGroupLabels': ['Darunavir 400mg/d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}