Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-20
Study Completion Date
2023-01-31
Brief Summary
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WHO had recommened rapid ART initiation, defined as starting ART within 7 days or on the same day after HIV diagnosis, to improve HIV care continuum. Prior studies revealed that point-of-care diagnostic methods for the detection of HIV RNA can accelerate linkage to care and reduce anxiety. By shortening the interval between infectious disease physician referral, time-lag between screening and confirmatory tests, with the use of the newly developed point-of-care immunochromatographic confirmatory test, initiating a safe and potent antiretroviral therapy, BIC/F/TAF, on the same day of HIV confirmation will be feasible to improve linkage to care and to shorten the interval between HIV diagnosis and viral suppression.
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Detailed Description
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Background In 2015, WHO recommended that all patients be treated with combination antiretroviral therapy (cART) once the diagnosis of HIV infection was made. On the population level, starting cART soon after HIV diagnosis can prevent onward HIV transmission. Although WHO has recommended "treat-all" policy since 2015, there were still 1.8 million people becoming newly infected with HIV in 20179. The substantial loss of patients during the HIV care continuum among the most vulnerable populations have been major concerns in the cART scale-up. Therefore, the concept of rapid ART initiation, defined as starting ART within 7 days or even on the same day after HIV diagnosis was confirmed, was introduced to improve HIV care continuum. In several clinical trials, loss to follow-up was observed despite the clinical trial settings. From our prior study18, among 786 individuals who were screened positive for HIV, 2.4% never returned to the clinic for the confirmatory tests. Despite ART scale-up and the policy of rapid initiation, 30% the of patients who were diagnosed with HIV infection during 2017-2018 did not initiate cART within 7 days after HIV diagnosis was made. Prior studies revealed that point-of-care diagnostic methods for detection of HIV RNA can accelerate linkage to care and reduce anxiety. However, the cost of and the barriers to accessing the point-of-care HIV RNA testing remain high. By shortening the interval between infectious disease physician referral, time-lag between screening and confirmatory tests, with the use of newly developed point-of-care immunochromatographic confirmatory test, initiating a safe and potent antiretroviral therapy on the same day of HIV confirmation will be feasible to improve linkage to care and to shorten the interval between HIV diagnosis and viral suppression.
Study aim This study objective is to investigate the feasibility and outcomes of same-day initiation with Biktarvy (Bic/F/TAF) among patients who receive a diagnosis of HIV infection by confirmatory test.
Study Interventions This is a multi-center, single-arm, prospective cohort study. All individuals who fulfill the inclusion/exclusion criteria will be enrolled in our study and followed for 48 weeks. During the first visit at ID clinic, baseline clinical data will be collected by history taking, physical examination, and blood testing. The confirmatory test and baseline evaluations will be performed at the Visit 1. The test results will also be reported on the same day. Patients, who are HIV(+) by confirmatory test ,will receive a 7-day Biktarvy treatment and the first dose will be administered from Visit 1 (Day 1). The results of other evaluation including viral load, CD4 count, and coinfection will be available at visit 2.
At Visit 2, the clinical symptoms and the tolerability will be recorded. If participants continue to receive Biktarvy® at the discretion of the HIV treating physicians, Biktarvy will be continued according to the national HIV treatment guidelines, which will be reimbursed by the National Health Insurance, and the patients will be followed in our study for 48 weeks. If the patients are switched to other cART regimens than Bictarvy according to physician's clinical judgements, the participants will continue their follow-up in the study.
During the follow-up period, clinical information on symptoms, tolerability, and adverse effects with the use of face-to-face questionnaire interviews, and follow-up laboratory test results will be collected. to evaluate the efficacy and adverse effect according to the national HIV treatment guidelines and routine clinical practices.
Monitor of Adverse event and management The subjective adverse events will be inquired during each visit and recorded with the use of questionnaire interviews. According to the national HIV treatment guidelines in Taiwan, the liver and renal functions and muscle enzymes will be followed during treatment as part of the standard of care. The study team will provide best clinical care if adverse events develop and the cost of medical care required will be covered by the insurance company. Severe adverse event and withdrawal from the study will be reported to the primary investigator on a monthly basis. When the number of drop-out is higher than 30%, the enrollment will be stopped temporarily until the investigation ensures the safety of the participants.
Study Endpoints
1. Primary endpoints 1) The rate of retention in care at Week 48 2) The proportion of viral suppression (\<50 copies/ml) at Week 48
2. Secondary endpoints 1) The rate of same-day initiation of ART among patients who receive a confirmed diagnosis of HIV infection 2) The proportion of viral suppression (\<200 copies/ml) at Weeks 1, 4, and 48 3) Any/severe adverse effect of B/F/TAF before Weeks 4 and 48 4) Patient's satisfaction at Weeks 1, 4, and 48
Statistical analysis
1. This is a feasibility study aiming to investigate the rate of engagement in same-day ART initiation and retention in care at Week 48. No sample size calculation is needed. The sample size of 200 participants is estimated by taking into account the case numbers of newly diagnosed HIV-positive patients seeking HIV care and cART at each participating hospitals during the past 1 year.
2. Timetable for study and enrollment:
1\) Total subjects expected to be enrolled: 200 2) Total subjects expected to enter treatment: 195 3) Total subjects expected to complete treatment: 191 4) Duration of enrolled period: 20 months 5) Number of subjects entering treatment per month: 10 ( 2 subjects per site)
Study aim This study objective is to investigate the feasibility and outcomes of same-day initiation with Biktarvy (Bic/F/TAF) among patients who receive a diagnosis of HIV infection by confirmatory test.
Study Interventions This is a multi-center, single-arm, prospective cohort study. All individuals who fulfill the inclusion/exclusion criteria will be enrolled in our study and followed for 48 weeks. During the first visit at ID clinic, baseline clinical data will be collected by history taking, physical examination, and blood testing. The confirmatory test and baseline evaluations will be performed at the Visit 1. The test results will also be reported on the same day. Patients, who are HIV(+) by confirmatory test ,will receive a 7-day Biktarvy treatment and the first dose will be administered from Visit 1 (Day 1). The results of other evaluation including viral load, CD4 count, and coinfection will be available at visit 2.
At Visit 2, the clinical symptoms and the tolerability will be recorded. If participants continue to receive Biktarvy® at the discretion of the HIV treating physicians, Biktarvy will be continued according to the national HIV treatment guidelines, which will be reimbursed by the National Health Insurance, and the patients will be followed in our study for 48 weeks. If the patients are switched to other cART regimens than Bictarvy according to physician's clinical judgements, the participants will continue their follow-up in the study.
During the follow-up period, clinical information on symptoms, tolerability, and adverse effects with the use of face-to-face questionnaire interviews, and follow-up laboratory test results will be collected. to evaluate the efficacy and adverse effect according to the national HIV treatment guidelines and routine clinical practices.
Monitor of Adverse event and management The subjective adverse events will be inquired during each visit and recorded with the use of questionnaire interviews. According to the national HIV treatment guidelines in Taiwan, the liver and renal functions and muscle enzymes will be followed during treatment as part of the standard of care. The study team will provide best clinical care if adverse events develop and the cost of medical care required will be covered by the insurance company. Severe adverse event and withdrawal from the study will be reported to the primary investigator on a monthly basis. When the number of drop-out is higher than 30%, the enrollment will be stopped temporarily until the investigation ensures the safety of the participants.
Study Endpoints
1. Primary endpoints 1) The rate of retention in care at Week 48 2) The proportion of viral suppression (\<50 copies/ml) at Week 48
2. Secondary endpoints 1) The rate of same-day initiation of ART among patients who receive a confirmed diagnosis of HIV infection 2) The proportion of viral suppression (\<200 copies/ml) at Weeks 1, 4, and 48 3) Any/severe adverse effect of B/F/TAF before Weeks 4 and 48 4) Patient's satisfaction at Weeks 1, 4, and 48
Statistical analysis
1. This is a feasibility study aiming to investigate the rate of engagement in same-day ART initiation and retention in care at Week 48. No sample size calculation is needed. The sample size of 200 participants is estimated by taking into account the case numbers of newly diagnosed HIV-positive patients seeking HIV care and cART at each participating hospitals during the past 1 year.
2. Timetable for study and enrollment:
1\) Total subjects expected to be enrolled: 200 2) Total subjects expected to enter treatment: 195 3) Total subjects expected to complete treatment: 191 4) Duration of enrolled period: 20 months 5) Number of subjects entering treatment per month: 10 ( 2 subjects per site)
Conditions
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HIV Infections
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Same-day initiation with BIC/F/TAF
Group Type
EXPERIMENTAL
Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]
Intervention Type
DRUG
Biktarvy will be administered on the same day of diagnosis. The daily dosing will be continued for 48 weeks.
Interventions
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Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]
Biktarvy will be administered on the same day of diagnosis. The daily dosing will be continued for 48 weeks.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients who test positive by HIV screening tests (4th generation Ag/Ab) by clinical care providers or by VCT counselors within 3 days of Visit 1.
* Aged 20 years or older
* Patient is willing to participate in this study and sign the written informed consent form
* Aged 20 years or older
* Patient is willing to participate in this study and sign the written informed consent form
Exclusion Criteria
* Prior HIV diagnosis
* Prior ART for HIV infection
* Chronic kidney disease, stage ≥4 (CCr \<30 ml/min/1.73m2) or receiving dialysis
* Severe hepatic impairment (Child-Pugh score C) or clinical apparent hepatic impairment including jaundice or ascites
* Active or latent tuberculosis infection or clinical apparent central nervous system infection
* Pregnancy or breastfeeding
* Allergy to FTC or TDF containing medication
* Prior ART for HIV infection
* Chronic kidney disease, stage ≥4 (CCr \<30 ml/min/1.73m2) or receiving dialysis
* Severe hepatic impairment (Child-Pugh score C) or clinical apparent hepatic impairment including jaundice or ascites
* Active or latent tuberculosis infection or clinical apparent central nervous system infection
* Pregnancy or breastfeeding
* Allergy to FTC or TDF containing medication
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Far Eastern Memorial Hospital
OTHER
Sponsor Role
collaborator
Mackay Memorial Hospital
OTHER
Sponsor Role
collaborator
Changhua Christian Hospital
OTHER
Sponsor Role
collaborator
Chung Shan Medical University
OTHER
Sponsor Role
collaborator
National Cheng-Kung University Hospital
OTHER
Sponsor Role
collaborator
Chi Mei Medical Hospital
OTHER
Sponsor Role
collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Sponsor Role
collaborator
Kaohsiung Municipal Ta-Tung Hospital
UNKNOWN
Sponsor Role
collaborator
National Taiwan University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Site Status
RECRUITING
Countries
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Taiwan
Facility Contacts
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References
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BACKGROUND
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BACKGROUND
Borges AH, Neuhaus J, Babiker AG, Henry K, Jain MK, Palfreeman A, Mugyenyi P, Domingo P, Hoffmann C, Read TR, Pujari S, Meulbroek M, Johnson M, Wilkin T, Mitsuyasu R; INSIGHT START Study Group. Immediate Antiretroviral Therapy Reduces Risk of Infection-Related Cancer During Early HIV Infection. Clin Infect Dis. 2016 Dec 15;63(12):1668-1676. doi: 10.1093/cid/ciw621. Epub 2016 Sep 8.
Reference Type
RESULT
Labhardt ND, Ringera I, Lejone TI, Klimkait T, Muhairwe J, Amstutz A, Glass TR. Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial. JAMA. 2018 Mar 20;319(11):1103-1112. doi: 10.1001/jama.2018.1818.
Reference Type
RESULT
Langwenya N, Phillips TK, Brittain K, Zerbe A, Abrams EJ, Myer L. Same-day antiretroviral therapy (ART) initiation in pregnancy is not associated with viral suppression or engagement in care: A cohort study. J Int AIDS Soc. 2018 Jun;21(6):e25133. doi: 10.1002/jia2.25133.
Reference Type
RESULT
Huang YC, Sun HY, Chuang YC, Huang YS, Lin KY, Huang SH, Chen GJ, Luo YZ, Wu PY, Liu WC, Hung CC, Chang SC. Short-term outcomes of rapid initiation of antiretroviral therapy among HIV-positive patients: real-world experience from a single-centre retrospective cohort in Taiwan. BMJ Open. 2019 Sep 20;9(9):e033246. doi: 10.1136/bmjopen-2019-033246.
Reference Type
RESULT
Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.
Reference Type
RESULT
Halperin J, Butler I, Conner K, Myers L, Holm P, Bartram L, Van Sickels N. Linkage and Antiretroviral Therapy Within 72 Hours at a Federally Qualified Health Center in New Orleans. AIDS Patient Care STDS. 2018 Feb;32(2):39-41. doi: 10.1089/apc.2017.0309. No abstract available.
Reference Type
RESULT
Girometti N, Nwokolo N, McOwan A, Whitlock G. Outcomes of acutely HIV-1-infected individuals following rapid antiretroviral therapy initiation. Antivir Ther. 2017;22(1):77-80. doi: 10.3851/IMP3080. Epub 2016 Sep 2.
Reference Type
RESULT
Koenig SP, Dorvil N, Devieux JG, Hedt-Gauthier BL, Riviere C, Faustin M, Lavoile K, Perodin C, Apollon A, Duverger L, McNairy ML, Hennessey KA, Souroutzidis A, Cremieux PY, Severe P, Pape JW. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017 Jul 25;14(7):e1002357. doi: 10.1371/journal.pmed.1002357. eCollection 2017 Jul.
Reference Type
RESULT
Stevens WS, Gous NM, MacLeod WB, Long LC, Variava E, Martinson NA, Sanne I, Osih R, Scott LE. Multidisciplinary Point-of-Care Testing in South African Primary Health Care Clinics Accelerates HIV ART Initiation but Does Not Alter Retention in Care. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):65-73. doi: 10.1097/QAI.0000000000001456.
Reference Type
RESULT
Meulbroek M, Pujol F, Perez F, Dalmau-Bueno A, Taboada H, Marazzi G, Carrillo A, Cabas A, Gata A, Aldabo E, Roldan B, Coll P, Anez F, Pantaleon J, Mochales M, Gomez V, Marin O, Mir JF, Decoca J, Saz J. BCN Checkpoint: same-day confirmation of reactive HIV rapid test with Point Of Care HIV-RNA accelerates linkage to care and reduces anxiety. HIV Med. 2018 Feb;19 Suppl 1:63-65. doi: 10.1111/hiv.12595.
Reference Type
RESULT
Other Identifiers
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202003020MIPB
Identifier Type: -
Identifier Source: org_study_id
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A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT00135395
COMPLETED
PHASE3
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
NCT01705574
COMPLETED
PHASE3
Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients
NCT01702090
COMPLETED
PHASE4
Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
NCT07031063
RECRUITING
PHASE4
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
NCT03998176
COMPLETED
PHASE4
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
NCT00450580
COMPLETED
PHASE3
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
NCT02652624
COMPLETED
PHASE3
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
NCT00530920
COMPLETED
PHASE2
A Study of JNJ-56136379 in Healthy Participants
NCT04853524
WITHDRAWN
PHASE1
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
NCT00144287
COMPLETED
PHASE3
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)
NCT05405751
COMPLETED
PHASE4
Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study
NCT01679964
COMPLETED
PHASE4