Bictegravir in the Elderly Living With HIV (BICEP)

NCT05064020 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: STUDY00003629
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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. Hypothesis: 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.

Conditions

HIV-1-infection

Keywords

HIV; Switch; Bictegravir; Drug-drug interaction; Polypharmacy; Elderly; Adherence; Quality of life

Outcome Measures

Primary Outcomes (1)

• Potential Drug Drug Interaction (PDDI)

  From week 1 to week 24 the study will assess PDDI and concurrent medications

  week 1 to week 24

Secondary Outcomes (6)

• Adherence

  Baseline, week 4, week 8, week 12 and week 24

• Lipid panel changes

  Baseline and week 24

• Blood pressure changes

  Baseline and week 24

• Blood glucose changes

  Baseline and week 24

• Health related quality of life

  Baseline, week 12 and week 24

Study Arms (2)

Polypharmacy

Polypharmacy: patient is using five or more medications will be considered polypharmacy. Subjects 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 \[BIKTARVY\]

Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]

Nonpolypharmacy

Nonpolypharmacy: patient is using less than five medications will be considered nonpolypharmacy Nonpolypharmacy 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 \[BIKTARVY\]

Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]

Interventions

Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] DRUG

Administer BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168.

Also known as: Biktarvy, BIC/FTC/TAF

Nonpolypharmacy; Polypharmacy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adult individuals \> 18 years of age.
• Able and willing to provide informed/signed consent.
• Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.
• Current antiretroviral therapy, Genvoya or Stribild for HIV-1 infection.
• At least 1 or more concurrent prescription medication.
• HIV VL \< 50 for over 6 months, no current OI, no cancers

You may not qualify if:

• Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study.
• Current antiretroviral therapy other than GenvoyaTM or StribildTM for HIV-1 infection.
• 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.
• 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.
• Use of prohibited protocol-specified drugs, prescription or over-the-counter medication (see Section 6.4.2) within 14 days prior to study entry.
• 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
• Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:
• Hemoglobin \< 12.5 g/dL for men; \< 11.5 g/dL for women;
• Platelet count \< 100,000 platelets/mm 3;
• AST (SGOT) or ALT (SGPT) \> 1.5 x the upper limit of normal (ULN);
• Estimated GFR \< 30 ml/min

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Gilead Sciences: collaborator

Study Sites (1)

Evergreen Health

Buffalo, New York, 14201, United States

Location

Related Publications (14)

• 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: 28867497 BACKGROUND

• 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: 23818773 BACKGROUND

• 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: 27645238 BACKGROUND

• 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: 28627229 BACKGROUND

• 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: 9619963 BACKGROUND

• 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: 24285760 BACKGROUND

• 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: 28219610 BACKGROUND

• 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: 21680580 BACKGROUND

• 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: 17083499 BACKGROUND

• 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.

  PMID: 10360804 BACKGROUND

• 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.

  BACKGROUND

• 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: 17389673 BACKGROUND

• 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: 20516524 BACKGROUND

• 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.

  PMID: 18575590 BACKGROUND

Related Links

• The link to the Citation that didn't find a PubMed ID
• The information related to Biktarvy package insert

MeSH Terms

Interventions

bictegravir; Emtricitabine; tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Qing Ma, PharmD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: October 1, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be summarized and presented in the conferences and scientific journals.
• Access Criteria: Please contact the principal investigator for an access to IPD.

Locations

US (1)