Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 7:55 PM
Study NCT ID:
NCT04311957
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2020-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to the B/F/TAF or continuation bPI group in a 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 386}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-03-15', 'studyFirstSubmitQcDate': '2020-03-15', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virologic failure - 200 Copies/mL cut-off', 'timeFrame': 'Week 48', 'description': 'Proportion of participants with HIV-1 RNA at least 200 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm'}], 'secondaryOutcomes': [{'measure': 'Virologic failure - 50 Copies/mL cut-off', 'timeFrame': 'Week 48', 'description': 'Proportion of participants with HIV-1 RNA at least 50 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm'}, {'measure': 'Virologic failure - 1000 Copies/mL cut-off', 'timeFrame': 'Week 48', 'description': 'Proportion of participants with HIV-1 RNA at least 1000 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm'}, {'measure': 'Tolerability as measured by discontinuing medication', 'timeFrame': 'Entry to 48 weeks', 'description': 'Proportion of participants discontinuing therapy for drug-related adverse events'}, {'measure': 'Adverse events', 'timeFrame': 'Entry to 48 weeks', 'description': 'Proportion of participants with 1 or more NIH Division of AIDS Grade 3 or 4 adverse events (at least 1 grade increase from baseline)'}, {'measure': 'Change in cholesterol', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median change in cholesterol'}, {'measure': 'Change in weight', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median change in weight in kilograms'}, {'measure': 'Change in body mass index', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median change in body mass index (weight in kilograms divided by the square of height in meters)'}, {'measure': 'Weight gain of 10% or greater', 'timeFrame': 'Entry to 48 weeks', 'description': 'Proportion of participants with weight gain of at least 10% (in kilograms)'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median change in waist circumference'}, {'measure': 'Waist to hip ratio', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median change in waist to hip ratio'}, {'measure': 'Adherence', 'timeFrame': 'Entry to 48 weeks', 'description': 'Median adherence as measured by pharmacy refill records'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Second-line therapy', 'Integrase strand transfer inhibitor', 'Protease inhibitor'], 'conditions': ['HIV-1-infection', 'Antiretroviral Therapy']}, 'referencesModule': {'references': [{'pmid': '40883049', 'type': 'DERIVED', 'citation': 'Severe P, Pierre S, Homeus F, Marc JB, Trevisi L, Aristhomene ML, Bernadin GR, Lavoile K, Rivera V, Duchatellier CF, Joseph MJ, Wu J, Rouzier V, Preval F, Jean E, Bernadin J, Zion A, Pierre Louis Forestal G, Avila-Rios S, Garcia Morales C, Zhang A, Israelski D, Apollon A, Dumont E, Fox E, Cremieux PY, Pape JW, Collins SE, Liautaud B, Sax PE, Koenig SP. Bictegravir, emtricitabine, and tenofovir alafenamide versus ritonavir-boosted protease inhibitor-based antiretroviral therapy in people with HIV and viral suppression on second-line therapy in Haiti: an open-label, randomised, non-inferiority trial. Lancet HIV. 2025 Sep;12(9):e616-e626. doi: 10.1016/S2352-3018(25)00130-4.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial compares the efficacy of switching to a fixed-dose combination of B/F/TAF versus continuing a boosted protease inhibitor (bPI) regimen in HIV-1 infected participants who are virologically suppressed (HIV-1 RNA \\<200 copies) on a second-line bPI regimen. Half of participants will receive B/F/TAF and half will continue a bPI regimen. The hypothesize is that B/F/TAF will have efficacy that is non-inferior to the boosted PI regimen.', 'detailedDescription': 'The second generation integrase strand transfer inhibitors (INSTIs) dolutegravir (DTG) and bictegravir (BIC) are widely prescribed for the treatment of HIV, due to their favorable tolerability and toxicity profile, durable efficacy, and high barrier to resistance. However, there are limited data to guide the management of patients who are already virally suppressed on a second-line bPI regimen.\n\nThough bPIs have a high barrier to resistance and durable virologic efficacy, they have several important drug-drug interactions, are associated with unfavorable long-term metabolic effects, and may be poorly tolerated. For these reasons, a second-generation INSTI would be preferable to a boosted PI regimen, as long INSTIs are demonstrated to have non-inferior efficacy for patients who are already suppressed on a second-line bPI regimen.\n\nIn the proposed study, the efficacy of continuing the bPI regimen will be compared to switching to B/F/TAF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The ability and willingness to give informed consent.\n* Age ≥18 years\n* History of meeting WHO criteria for immunologic or virologic failure after receipt of a first-line treatment regimen for ≥6 months\n* Currently receiving a second-line ART regimen including either ATVr or LPVr + 2 NRTIs for ≥6 months\n* At least one HIV-1 RNA \\<200 copies/mL within 12 months prior to enrollment, and no HIV-1 RNA of at least 200 copies/mL during this period.\n* Plasma HIV-1 RNA \\<200 copies/mL at Screening Visit.\n* eGFR ≥ 50 mL/min according to the MDRD study equation for creatinine clearance\n* Hepatic transaminases (AST and ALT) \\</=5X upper limit of normal (ULN)\n* No active TB\n* Women of childbearing age must agree to take reliable contraception\n\nExclusion Criteria:\n\n* Active World Health Organization Stage 3 or 4 condition\n* Treatment with an INSTI in the past\n* Gap in care of at least one month in the prior six months\n* Current alcohol or substance use judged by investigator to potentially interfere with participant study compliance\n* History of poor adherence, that in the opinion of the investigator, would potentially interfere with study compliance\n* Pregnant or breastfeeding at screening visit\n* Planning to transfer care'}, 'identificationModule': {'nctId': 'NCT04311957', 'briefTitle': 'Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults', 'organization': {'class': 'OTHER', 'fullName': "Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic"}, 'officialTitle': 'A Randomized Non-Inferiority Trial to Compare the Efficacy of Switching From Protease-Inhibitor Based Second-Line Therapy to Bictegravir-Tenofovir Alafenamide-Emtricitabine in Virologically Suppressed Adults in Haiti', 'orgStudyIdInfo': {'id': 'CO-US-380-5733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Boosted PI Group', 'description': 'Continuation of the same second-line regimen taken prior to entry:\n\nThis includes either Lopinavir/ritonavir (LPVr) 400 mg/100 mg BID or Atazanavir/ritonavir (ATV/r) 300 mg/100 mg QD\n\nplus 2 nucleoside reverse transcriptase inhibitors (NRTIs).', 'interventionNames': ['Drug: Continuation of boosted PI']}, {'type': 'EXPERIMENTAL', 'label': 'B/F/TAF Group', 'description': 'Combination tablet of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily.', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'Continuation of boosted PI', 'type': 'DRUG', 'description': 'Continuation of the same second-line regimen taken prior to entry:\n\nLPVr 400 mg/100 mg BID or ATVr 300 mg/100 mg QD + 2 NRTIs', 'armGroupLabels': ['Boosted PI Group']}, {'name': 'B/F/TAF', 'type': 'DRUG', 'description': 'Single-tablet, fixed dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily.', 'armGroupLabels': ['B/F/TAF Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Port-au-Prince', 'country': 'Haiti', 'contacts': [{'name': 'Patrice Severe, MD', 'role': 'CONTACT', 'email': 'patsevere@gheskio.org', 'phone': '3448-5963'}, {'name': 'Samuel Pierre, MD', 'role': 'CONTACT', 'email': 'spierre@gheskio.org', 'phone': '3740-7711'}, {'name': 'Patrice Severe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Samuel Pierre, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'GHESKIO', 'geoPoint': {'lat': 18.54349, 'lon': -72.33881}}], 'centralContacts': [{'name': 'Patrice Severe, MD', 'role': 'CONTACT', 'email': 'patsevere@gheskio.org', 'phone': '718-962-4585'}, {'name': 'Serena Koenig, MD', 'role': 'CONTACT', 'email': 'skoenig@bwh.harvard.edu', 'phone': '617-413-4090'}], 'overallOfficials': [{'name': 'Patrice Severe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic"}, {'name': 'Serena Koenig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital/Harvard Medical School"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic", 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Analysis Group, Inc.', 'class': 'INDUSTRY'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}