drugset / Trial / NCT04712058
Same-day Antiretroviral Therapy With BIC/F/TAF
Unknown
200 enrolled
National Taiwan University Hospital
Changhua Christian Hospital · collabChi Mei Medical Hospital · collabChung Shan Medical University · collabFar Eastern Memorial Hospital · collabKaohsiung Medical University Chung-Ho Memorial Hospital · collabKaohsiung Municipal Ta-Tung Hospital · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-01-20
- Primary completion
- 2022-12-31
- Completion
- 2023-01-31
Publications
- Background TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
- Background INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.
- Background O'Connor J, Vjecha MJ, Phillips AN, Angus B, Cooper D, Grinsztejn B, Lopardo G, Das S, Wood R, Wilkin A, Klinker H, Kantipong P, Klingman KL, Jilich D, Herieka E, Denning E, Abubakar I, Gordin F, Lundgren JD; INSIGHT START study group. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per muL: secondary outcome results from a randomised controlled trial. Lancet HIV. 2017 Mar;4(3):e105-e112. doi: 10.1016/S2352-3018(16)30216-8. Epub 2017 Jan 5.
- Background Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
- Background Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
- Background Rodger AJ, Cambiano V, Bruun T, Vernazza P, Collins S, Degen O, Corbelli GM, Estrada V, Geretti AM, Beloukas A, Raben D, Coll P, Antinori A, Nwokolo N, Rieger A, Prins JM, Blaxhult A, Weber R, Van Eeden A, Brockmeyer NH, Clarke A, Del Romero Guerrero J, Raffi F, Bogner JR, Wandeler G, Gerstoft J, Gutierrez F, Brinkman K, Kitchen M, Ostergaard L, Leon A, Ristola M, Jessen H, Stellbrink HJ, Phillips AN, Lundgren J; PARTNER Study Group. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet. 2019 Jun 15;393(10189):2428-2438. doi: 10.1016/S0140-6736(19)30418-0. Epub 2019 May 2.
- Background Minn AC, Kyaw NTT, Aung TK, Mon OM, Htun T, Oo MM, Moe J, Mon AA, Satyanarayana S, Oo HN. Attrition among HIV positive children enrolled under integrated HIV care programme in Myanmar: 12 years cohort analysis. Glob Health Action. 2018;11(1):1510593. doi: 10.1080/16549716.2018.1510593.
- Background Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011 Jul;8(7):e1001056. doi: 10.1371/journal.pmed.1001056. Epub 2011 Jul 19.
- Background Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy. Geneva: World Health Organization; 2017. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK475977/
- Background Pilcher CD, Ospina-Norvell C, Dasgupta A, Jones D, Hartogensis W, Torres S, Calderon F, Demicco E, Geng E, Gandhi M, Havlir DV, Hatano H. The Effect of Same-Day Observed Initiation of Antiretroviral Therapy on HIV Viral Load and Treatment Outcomes in a US Public Health Setting. J Acquir Immune Defic Syndr. 2017 Jan 1;74(1):44-51. doi: 10.1097/QAI.0000000000001134.
- Background Amanyire G, Semitala FC, Namusobya J, Katuramu R, Kampiire L, Wallenta J, Charlebois E, Camlin C, Kahn J, Chang W, Glidden D, Kamya M, Havlir D, Geng E. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV. 2016 Nov;3(11):e539-e548. doi: 10.1016/S2352-3018(16)30090-X. Epub 2016 Aug 27.
- Background Rosen S, Maskew M, Fox MP, Nyoni C, Mongwenyana C, Malete G, Sanne I, Bokaba D, Sauls C, Rohr J, Long L. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial. PLoS Med. 2016 May 10;13(5):e1002015. doi: 10.1371/journal.pmed.1002015. eCollection 2016 May.
- Background Malloch L, Kadivar K, Putz J, Levett PN, Tang J, Hatchette TF, Kadkhoda K, Ng D, Ho J, Kim J. Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I. J Clin Virol. 2013 Dec;58 Suppl 1:e85-91. doi: 10.1016/j.jcv.2013.08.008. Epub 2013 Aug 28.
- Background Moon HW, Huh HJ, Oh GY, Lee SG, Lee A, Yun YM, Hur M. Evaluation of the Bio-Rad Geenius HIV 1/2 Confirmation Assay as an Alternative to Western Blot in the Korean Population: A Multi-Center Study. PLoS One. 2015 Sep 30;10(9):e0139169. doi: 10.1371/journal.pone.0139169. eCollection 2015.
- Background Tinguely C, Schild-Spycher T, Bahador Z, Gowland P, Stolz M, Niederhauser C. Comparison of a conventional HIV 1/2 line immunoassay with a rapid confirmatory HIV 1/2 assay. J Virol Methods. 2014 Sep;206:1-4. doi: 10.1016/j.jviromet.2014.05.010. Epub 2014 May 27.
- Background Misumi J, Gardes J, Gonzalez MF, Corvol P, Menard J. Angiotensinogen's role in ANG formation, renin release, and renal hemodynamics in isolated perfused kidney. Am J Physiol. 1989 Apr;256(4 Pt 2):F719-27. doi: 10.1152/ajprenal.1989.256.4.F719.
- Background 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bictegravir / Emtricitabine / Tenofovir Alafenamide | Other / unclassified | — | Oral |