AntiRetroviral Therapy In Second-line: investigating Tenofovir-lamivudine-dolutegravir (ARTIST): protocol for a randomised controlled trial [version 1; peer review: 2 approved, 1 approved with reservations]

Background: Dolutegravir has superior efficacy and tolerability than lopinavir-ritonavir in second-line antiretroviral therapy after failure of a first-line non-nucleoside reverse transcriptase inhibitors-based regimen, when dolutegravir is accompanied by at least one fully active nucleoside reverse transcriptase inhibitor (NRTI). Resistance testing to select NRTIs is not feasible in low-and middle-income countries due to cost and limited laboratory capacity. Evidence suggests that

[1]  P. Kaleebu,et al.  Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial. , 2022, The lancet. HIV.

[2]  A. Siika,et al.  Dolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV. , 2021, The New England journal of medicine.

[3]  Nucleosides And Darunavir/Dolutegravir In Africa , 2019, Case Medical Research.

[4]  Kimberly Smith,et al.  Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial. , 2019, The Lancet. Infectious diseases.

[5]  Loriene Roy.  What Is a Reference Source? , 2018, The Reference Librarian.

[6]  N. Ford,et al.  The transition to dolutegravir and other new antiretrovirals in low-income and middle-income countries: what are the issues? , 2018, AIDS.

[7]  R. Shapiro,et al.  Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception. , 2018, The New England journal of medicine.

[8]  P. Easterbrook,et al.  Lopinavir plus nucleoside reverse-transcriptase inhibitors, lopinavir plus raltegravir, or lopinavir monotherapy for second-line treatment of HIV (EARNEST): 144-week follow-up results from a randomised controlled trial , 2018, The Lancet. Infectious diseases.

[9]  Eleni-Rosalina Andrinopoulou,et al.  Dolutegravir as maintenance monotherapy for HIV (DOMONO): a phase 2, randomised non-inferiority trial. , 2017, The lancet. HIV.

[10]  M. Wainberg,et al.  The M184I/V and K65R nucleoside resistance mutations in HIV-1 prevent the emergence of resistance mutations against dolutegravir , 2016, AIDS.

[11]  Robert Koch-Institut.  Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study , 2016, The Lancet. Infectious diseases.

[12]  C. Barker,et al.  The HIV Treatment Gap: Estimates of the Financial Resources Needed versus Available for Scale-Up of Antiretroviral Therapy in 97 Countries from 2015 to 2020 , 2015, PLoS medicine.

[13]  S. Walmsley,et al.  Dolutegravir – a review of the pharmacology, efficacy, and safety in the treatment of HIV , 2015, Drug design, development and therapy.

[14]  D. Haas,et al.  Pharmacogenetics of plasma efavirenz exposure in HIV-infected adults and children in South Africa. , 2015, British journal of clinical pharmacology.

[15]  S. Piscitelli,et al.  Effects of enzyme inducers efavirenz and tipranavir/ritonavir on the pharmacokinetics of the HIV integrase inhibitor dolutegravir , 2014, European Journal of Clinical Pharmacology.

[16]  N. Parkin,et al.  Short communication: the number of HIV major NRTI mutations correlates directly with other antiretroviral-associated mutations and indirectly with replicative capacity and reduced drug susceptibility. , 2008, AIDS research and human retroviruses.

[17]  W. Heneine,et al.  The Fitness Cost of Mutations Associated with Human Immunodeficiency Virus Type 1 Drug Resistance Is Modulated by Mutational Interactions , 2006, Journal of Virology.

[18]  Joel E Gallant,et al.  Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. , 2006, The New England journal of medicine.

[19]  Catia Marzolini,et al.  Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study , 2004, AIDS.