Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT05064020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bictegravir in the Elderly Living With HIV (BICEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620396', 'term': 'bictegravir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-05', 'size': 368723, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-21T11:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential Drug Drug Interaction (PDDI)', 'timeFrame': 'week 1 to week 24', 'description': 'From week 1 to week 24 the study will assess PDDI and concurrent medications'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'Baseline, week 4, week 8, week 12 and week 24', 'description': 'Study team will evaluate patient adherence'}, {'measure': 'Lipid panel changes', 'timeFrame': 'Baseline and week 24', 'description': 'Lipid panel including total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride, will be monitored at baseline and week 24'}, {'measure': 'Blood pressure changes', 'timeFrame': 'Baseline and week 24', 'description': 'Blood pressure will be monitored at baseline and week 24'}, {'measure': 'Blood glucose changes', 'timeFrame': 'Baseline and week 24', 'description': 'Blood glucose will be monitored at baseline and week 24'}, {'measure': 'Health related quality of life', 'timeFrame': 'Baseline, week 12 and week 24', 'description': 'Health related quality of life will be evaluated based on HIV Symptom Index (range 0-80, lower scores suggest better quality of life)'}, {'measure': 'Neurocognitive impairment', 'timeFrame': 'Baseline, week 12 and week 24', 'description': 'Neurocognitive impairment will be evaluated using Montreal Cognitive Assessment (MoCA) at baseline, week 12 and week 24.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Switch', 'Bictegravir', 'Drug-drug interaction', 'Polypharmacy', 'Elderly', 'Adherence', 'Quality of life'], 'conditions': ['HIV-1-infection']}, 'referencesModule': {'references': [{'pmid': '28867497', 'type': 'BACKGROUND', 'citation': 'Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.'}, {'pmid': '23818773', 'type': 'BACKGROUND', 'citation': 'Gleason LJ, Luque AE, Shah K. Polypharmacy in the HIV-infected older adult population. Clin Interv Aging. 2013;8:749-63. doi: 10.2147/CIA.S37738. Epub 2013 Jun 21.'}, {'pmid': '27645238', 'type': 'BACKGROUND', 'citation': 'Tsiang M, Jones GS, Goldsmith J, Mulato A, Hansen D, Kan E, Tsai L, Bam RA, Stepan G, Stray KM, Niedziela-Majka A, Yant SR, Yu H, Kukolj G, Cihlar T, Lazerwith SE, White KL, Jin H. Antiviral Activity of Bictegravir (GS-9883), a Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile. Antimicrob Agents Chemother. 2016 Nov 21;60(12):7086-7097. doi: 10.1128/AAC.01474-16. Print 2016 Dec.'}, {'pmid': '28627229', 'type': 'BACKGROUND', 'citation': 'Tseng A, Hughes CA, Wu J, Seet J, Phillips EJ. Cobicistat Versus Ritonavir: Similar Pharmacokinetic Enhancers But Some Important Differences. Ann Pharmacother. 2017 Nov;51(11):1008-1022. doi: 10.1177/1060028017717018. Epub 2017 Jun 19.'}, {'pmid': '9619963', 'type': 'BACKGROUND', 'citation': 'van den Akker M, Buntinx F, Metsemakers JF, Roos S, Knottnerus JA. Multimorbidity in general practice: prevalence, incidence, and determinants of co-occurring chronic and recurrent diseases. J Clin Epidemiol. 1998 May;51(5):367-75. doi: 10.1016/s0895-4356(97)00306-5.'}, {'pmid': '24285760', 'type': 'BACKGROUND', 'citation': 'Tseng A, Szadkowski L, Walmsley S, Salit I, Raboud J. Association of age with polypharmacy and risk of drug interactions with antiretroviral medications in HIV-positive patients. Ann Pharmacother. 2013 Nov;47(11):1429-39. doi: 10.1177/1060028013504075.'}, {'pmid': '28219610', 'type': 'BACKGROUND', 'citation': 'Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.'}, {'pmid': '21680580', 'type': 'BACKGROUND', 'citation': 'Marzolini C, Back D, Weber R, Furrer H, Cavassini M, Calmy A, Vernazza P, Bernasconi E, Khoo S, Battegay M, Elzi L; Swiss HIV Cohort Study Members. Ageing with HIV: medication use and risk for potential drug-drug interactions. J Antimicrob Chemother. 2011 Sep;66(9):2107-11. doi: 10.1093/jac/dkr248. Epub 2011 Jun 16.'}, {'pmid': '17083499', 'type': 'BACKGROUND', 'citation': 'Mrus JM, Leonard AC, Yi MS, Sherman SN, Fultz SL, Justice AC, Tsevat J. Health-related quality of life in veterans and nonveterans with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S39-47. doi: 10.1111/j.1525-1497.2006.00644.x.'}, {'pmid': '10360804', 'type': 'BACKGROUND', 'citation': 'Justice AC, Rabeneck L, Hays RD, Wu AW, Bozzette SA. Sensitivity, specificity, reliability, and clinical validity of provider-reported symptoms: a comparison with self-reported symptoms. Outcomes Committee of the AIDS Clinical Trials Group. J Acquir Immune Defic Syndr. 1999 Jun 1;21(2):126-33.'}, {'type': 'BACKGROUND', 'citation': 'Sax PE, Pozniak A, Arribas J, et al. Phase 3 randomized, controlled, clinical trial of bictegravir coformulated with FTC/TAF in a fixed-dose combination vs dolutegravir + FTC/TAF in treatment-naïve HIV-1-positive adults: Week 48 results. International AIDS Society (IAS) Conference on HIV Science; July 23-26, 2017; Paris, France. Levin: Conference reports for National AIDS Treatment Advocacy Project (NATAP); 2017.'}, {'pmid': '17389673', 'type': 'BACKGROUND', 'citation': 'Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother. 2007 Apr;41(4):674-80. doi: 10.1345/aph.1H423. Epub 2007 Mar 27.'}, {'pmid': '20516524', 'type': 'BACKGROUND', 'citation': 'Letendre SL, Ellis RJ, Ances BM, McCutchan JA. Neurologic complications of HIV disease and their treatment. Top HIV Med. 2010 Apr-May;18(2):45-55.'}, {'pmid': '18575590', 'type': 'BACKGROUND', 'citation': 'Ancuta P, Kamat A, Kunstman KJ, Kim EY, Autissier P, Wurcel A, Zaman T, Stone D, Mefford M, Morgello S, Singer EJ, Wolinsky SM, Gabuzda D. Microbial translocation is associated with increased monocyte activation and dementia in AIDS patients. PLoS One. 2008 Jun 25;3(6):e2516. doi: 10.1371/journal.pone.0002516.'}], 'seeAlsoLinks': [{'url': 'http://www.natap.org/2017/IAS/IAS_39.htm', 'label': "The link to the Citation that didn't find a PubMed ID"}, {'url': 'https://www.biktarvyhcp.com/dosing-administration/dosing', 'label': 'The information related to Biktarvy package insert'}]}, 'descriptionModule': {'briefSummary': "This is a prospective, open-label, single center, post-approval and post-marketing study. Current national guideline recommends an integrase strand inhibitors (INSTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) as standard of therapy for HIV-1 infected patients. INSTI-based regimen may require a potent CYP3A inhibitor such as cobicistat to increase INSTI's plasma concentration and prolongs half-life. However, co-administration with a CYP3A inhibitor may increase the risk of drug-drug interactions. A novel INSTI, bictegravir, does not need a booster for pharmacokinetic enhancement.\n\nHypothesis: switching HIV-1 infected patients from booster containing regimen to bictegravir based regimen would decrease the risk of drug-drug interactions caused by a booster and improve quality of life and adherence.", 'detailedDescription': 'Antiretroviral treatment consisting of integrase strand inhibitors (INSTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) has become the standard of therapy for HIV-1 infected patients (2017 DHHS Guidelines). The development and advancement of such therapy have resulted in improved prognosis, allowing a larger proportion of patients in United States (\\> 50%) with HIV-1 infection to be 50 years of age or older, which is defined by the CDC as "older adults". A novel INSTI, bictegravir (BIC), has been recently approved by FDA, available in a fixed dose combination with emtricitabine (FTC) and tenofovir alafenamide (TAF) as a novel single-tablet regimen (STR), BIKTARVY®. Similar to other INSTI, BIC prevents HIV replication by inhibiting HIV integration into the host cell. In vitro studies have shown its selectivity against HIV-1 infected cells with a low cytotoxic profile.\n\nElvitegravir, boosted with cobicistat, is currently available as part of a single-tablet formulation with FTC and TAF (GenvoyaTM) or with FTC and TDF (StribildTM). Unlike ritonavir, cobicistat has no antiretroviral activity, but has potent inhibitory effects on CYP3A44. Elvitegravir is primarily metabolized by CYP3A4 and its co-administration with cobicistat boosts elvitegravir plasma concentration and prolongs its half-life4. Concurrent use of a potent CYP3A4 inhibitor, e.g., cobicistat, with medications that are metabolized by CYP3A4 can significantly increase the risk of drug-drug interactions. With an increase in the average survivability age of HIV-infected patients, chances of polypharmacy due to multimorbidity, a term used to define the presence of two or more concurrent chronic medical conditions, increases. Two studies have demonstrated that older HIV+ individuals engaged in polypharmacy are more likely to experience potential drug-drug interactions (PDDI). Many chronic medications such as antidepressants, HMG-CoA reductase inhibitors (statins), and cardiovascular medications are metabolized by CYP3A4. Concurrent administration of these medications with GenvoyaTM and StribildTMcan lead to increases in PDDI. Such interactions can result in more adverse drug reactions, drug-related toxicity of narrow therapeutic index drugs, and variations in the efficacy of concurrent medications. However, unlike elvitegravir, BIC does not require a booster such as cobicistat for pharmacokinetic enhancement. Its use can result in reductions in PDDI caused by cobicistat in adults with polypharmacy. This can improve quality of life in general, adherence and can directly avoid DDI-related adverse effects.\n\nAlthough antiretroviral therapy (ART), when used concurrently with certain medications, has an increased risk of PDDI, studies have suggested a low DDI profile of BIC. In this study, such benefits of bictegravir will be assessed through the evaluation of polypharmacy, PDDI, health-related quality of life, and adherence of HIV-infected subjects.\n\nBIC/FTC/TAF related adverse drug events are possible in the study. Due to BIC\'s recent FDA approval, a comprehensive list on the possible adverse drug events has become available. Common side effects reported in clinical phase II and phase III studies include diarrhea, nausea, and headache. Serious adverse events, including lactic acidosis, severe hepatomegaly have been reported with nucleoside reverse transcriptase inhibitors, but are uncommon. The standard regimen of BIC/FTC/TAF will be used; if a regimen change occurs, participation in the study will be discontinued. Participants will be carefully screened and those with pre-conditions, such as morbid obesity, hepatitis B virus, hepatitis C virus co-infection will be documented in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult individuals \\> 18 years of age with HIV-1, currently on antiretroviral therapy, Genvoya or Stribild, at least 1 or more concurrent prescription medication and HIV viral load \\< 50 c/ml for over 6 months, no current OI, no cancers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult individuals \\> 18 years of age.\n* Able and willing to provide informed/signed consent.\n* Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.\n* Current antiretroviral therapy, Genvoya or Stribild for HIV-1 infection.\n* At least 1 or more concurrent prescription medication.\n* HIV VL \\< 50 for over 6 months, no current OI, no cancers\n\nExclusion Criteria:\n\n* Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study.\n* Current antiretroviral therapy other than GenvoyaTM or StribildTM for HIV-1 infection.\n* Pregnancy or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.\n* Chronic, severe, or other medical conditions that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol.\n* Use of prohibited protocol-specified drugs, prescription or over-the-counter medication (see Section 6.4.2) within 14 days prior to study entry.\n* Moderate or severe cognitive impairment by history that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol\n* Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:\n\n 1. Hemoglobin \\< 12.5 g/dL for men; \\< 11.5 g/dL for women;\n 2. Platelet count \\< 100,000 platelets/mm 3;\n 3. AST (SGOT) or ALT (SGPT) \\> 1.5 x the upper limit of normal (ULN);\n 4. Estimated GFR \\< 30 ml/min"}, 'identificationModule': {'nctId': 'NCT05064020', 'briefTitle': 'Bictegravir in the Elderly Living With HIV (BICEP)', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP)', 'orgStudyIdInfo': {'id': 'STUDY00003629'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Polypharmacy', 'description': 'Polypharmacy: patient is using five or more medications will be considered polypharmacy.\n\nSubjects having polypharmacy condition with taking Elvitegravir/Cobicistat/Emtricitabine/Tenofovir/Alafenamide 150MG-150MG-200MG-10MG Oral Tablet \\[Genvoya\\] or Elevitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate 150MG-150MG-200MG-300MG Oral Tablet \\[Stribild\\] will switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet \\[BIKTARVY\\]', 'interventionNames': ['Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]']}, {'label': 'Nonpolypharmacy', 'description': 'Nonpolypharmacy: patient is using less than five medications will be considered nonpolypharmacy\n\nNonpolypharmacy Subjects taking Elvitegravir/Cobicistat/Emtricitabine/Tenofovir/Alafenamide 150MG-150MG-200MG-10MG Oral Tablet \\[Genvoya\\] or Elevitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate 150MG-150MG-200MG-300MG Oral Tablet \\[Stribild\\] will switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet \\[BIKTARVY\\]', 'interventionNames': ['Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]']}], 'interventions': [{'name': 'Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]', 'type': 'DRUG', 'otherNames': ['Biktarvy', 'BIC/FTC/TAF'], 'description': 'Administer BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168.', 'armGroupLabels': ['Nonpolypharmacy', 'Polypharmacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14201', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Evergreen Health', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Qing Ma, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The data will be summarized and presented in the conferences and scientific journals.', 'ipdSharing': 'YES', 'description': 'We will share de-identified IPD only.', 'accessCriteria': 'Please contact the principal investigator for an access to IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qing Ma, PharmD', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}