HIV-1-infectionNCT05064020
Bictegravir in the Elderly Living With HIV (BICEP)
An observational study of HIV-1-infection, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
- Type of treatment
- Pill or oral medicine
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP)
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.
Read the detailed description
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.
Elvitegravir, 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.
Although 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.
BIC/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.
- Conditions
- HIV-1-infection
- Being tested
- Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
- Keywords
- HIV, Switch, Bictegravir, Drug-drug interaction, Polypharmacy, Elderly, Adherence, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]Drug
Also called Biktarvy, BIC/FTC/TAF
Administer BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168.
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential Drug Drug Interaction (PDDI)
From week 1 to week 24 the study will assess PDDI and concurrent medications
Measured: week 1 to week 24
Secondary outcomes (6)
Adherence
Study team will evaluate patient adherence
Measured: Baseline, week 4, week 8, week 12 and week 24
Lipid panel changes
Lipid panel including total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride, will be monitored at baseline and week 24
Measured: Baseline and week 24
Blood pressure changes
Blood pressure will be monitored at baseline and week 24
Measured: Baseline and week 24
Blood glucose changes
Blood glucose will be monitored at baseline and week 24
Measured: Baseline and week 24
Health related quality of life
Health related quality of life will be evaluated based on HIV Symptom Index (range 0-80, lower scores suggest better quality of life)
Measured: Baseline, week 12 and week 24
Neurocognitive impairment
Neurocognitive impairment will be evaluated using Montreal Cognitive Assessment (MoCA) at baseline, week 12 and week 24.
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Qing Ma, PharmD, State University of New York at Buffalo
- Investigators
- Qing Ma, PharmD, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064020
- Sponsor's protocol ID
- STUDY00003629
- Status last verified
- May 2024
- First submitted
- 15 Jul 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified IPD only.
Publications
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.
PubMed 28867497Gleason 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.
PubMed 23818773Tsiang 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.
PubMed 27645238Tseng 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.
PubMed 28627229van 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.
PubMed 9619963Tseng 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.
PubMed 24285760Sax 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.
PubMed 28219610Marzolini 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.
PubMed 21680580Mrus 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.
PubMed 17083499Justice 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.
PubMed 10360804Sax 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.
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.
PubMed 17389673Letendre 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.
PubMed 20516524Ancuta 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.
PubMed 18575590
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP)
- ClinicalTrials.gov ID
- NCT05064020
- Acronym / sponsor ID
- STUDY00003629
- Conditions
- HIV-1-infection
- Keywords
- HIV, Switch, Bictegravir, Drug-drug interaction, Polypharmacy, Elderly, Adherence, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Elvitegravir, 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.
Although 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.
BIC/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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypharmacy | – | Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]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] |
| Nonpolypharmacy | – | Drug: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]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] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]Also: Biktarvy, BIC/FTC/TAFAdminister BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168. | Drug | Nonpolypharmacy, Polypharmacy |
Primary outcome
Potential Drug Drug Interaction (PDDI)
Time frame: week 1 to week 24
From week 1 to week 24 the study will assess PDDI and concurrent medications
6 secondary outcomes
Adherence
Time frame: Baseline, week 4, week 8, week 12 and week 24
Lipid panel changes
Time frame: Baseline and week 24
Blood pressure changes
Time frame: Baseline and week 24
Blood glucose changes
Time frame: Baseline and week 24
Health related quality of life
Time frame: Baseline, week 12 and week 24
Neurocognitive impairment
Time frame: Baseline, week 12 and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 28867497Gallant 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.
- Background: PubMed 23818773Gleason 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.
- Background: PubMed 27645238Tsiang 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.
- Background: PubMed 28627229Tseng 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.
- Background: PubMed 9619963van 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.
- Background: PubMed 24285760Tseng 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.
- Background: PubMed 28219610Sax 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.
- Background: PubMed 21680580Marzolini 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.
- Background: PubMed 17083499Mrus 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.
- Background: PubMed 10360804Justice 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.
- BackgroundSax 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: PubMed 17389673Horn 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.
- The link to the Citation that didn't find a PubMed IDLink provided by the sponsor.
- The information related to Biktarvy package insertLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share de-identified IPD only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Ma, PharmD, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential Drug Drug Interaction (PDDI) (time frame: week 1 to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064020, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.