Etravirine in treatment‐experienced, HIV‐1‐infected children and adolescents: 48‐week safety, efficacy and resistance analysis of the phase II PIANO study

PIANO (Paediatric study of Intelence As an NNRTI Option; TMC125‐C213; NCT00665847) assessed the safety/tolerability, antiviral activity and pharmacokinetics of etravirine plus an optimized background regimen (OBR) in treatment‐experienced, HIV‐1‐infected children (≥ 6 to < 12 years) and adolescents (≥ 12 to < 18 years) over 48 weeks.

[1]  L. Conner,et al.  Predictors of antiretroviral medication adherence among a diverse cohort of adolescents with HIV. , 2012, The Journal of adolescent health : official publication of the Society for Adolescent Medicine.

[2]  R. Mendez,et al.  Assessment of adherence to antiretroviral therapy , 2012 .

[3]  D. Podzamczer,et al.  Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. , 2012, The Journal of antimicrobial chemotherapy.

[4]  Christoph Königs,et al.  Pharmacokinetics and short-term safety and tolerability of etravirine in treatment-experienced HIV-1-infected children and adolescents , 2012, AIDS.

[5]  Sylvie Naar-King,et al.  Barriers to Medication Adherence in Behaviorally and Perinatally Infected Youth Living with HIV , 2012, AIDS and Behavior.

[6]  B. Gazzard,et al.  Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results , 2011, AIDS.

[7]  Huldrych F Günthard,et al.  2011 update of the drug resistance mutations in HIV-1. , 2011, Topics in antiviral medicine.

[8]  J. Vingerhoets,et al.  Effect of Mutations at Position E138 in HIV-1 Reverse Transcriptase on Phenotypic Susceptibility and Virologic Response to Etravirine , 2011, Journal of acquired immune deficiency syndromes.

[9]  N. Rakhmanina,et al.  Antiretroviral Drugs in Pediatric HIV-Infected Patients , 2011, Paediatric drugs.

[10]  B. Gazzard,et al.  A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population , 2011, AIDS.

[11]  A. Winston,et al.  A phase IV, double-blind, multicentre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine , 2011, AIDS.

[12]  E. Snoeck,et al.  Pharmacokinetics and Pharmacodynamics of the Non‐Nucleoside Reverse‐Transcriptase Inhibitor Etravirine in Treatment‐Experienced HIV‐1‐Infected Patients , 2010, Clinical pharmacology and therapeutics.

[13]  R. Haubrich,et al.  Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials , 2010, Antiviral therapy.

[14]  Hilde Azijn,et al.  Resistance profile of etravirine: combined analysis of baseline genotypic and phenotypic data from the randomized, controlled Phase III clinical studies , 2010, AIDS.

[15]  R. Haubrich,et al.  Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials , 2009, AIDS.

[16]  D. Clifford,et al.  Long-Term Impact of Efavirenz on Neuropsychological Performance and Symptoms in HIV-Infected Individuals (ACTG 5097s) , 2009, HIV clinical trials.

[17]  D. Harris,et al.  Patient-related risks for nonadherence to antiretroviral therapy among HIV-infected youth in the United States: a study of prevalence and interactions. , 2009, AIDS patient care and STDs.

[18]  S. Reisner,et al.  A review of HIV antiretroviral adherence and intervention studies among HIV-infected youth. , 2009, Topics in HIV medicine : a publication of the International AIDS Society, USA.

[19]  C. Königs,et al.  PENTA 2009 guidelines for the use of antiretroviral therapy in paediatric HIV‐1 infection , 2002, HIV medicine.

[20]  C. Merzel,et al.  Adherence to antiretroviral therapy among older children and adolescents with HIV: a qualitative study of psychosocial contexts. , 2008, AIDS patient care and STDs.

[21]  D. Richman,et al.  2022 update of the drug resistance mutations in HIV-1. , 2022, Topics in antiviral medicine.

[22]  W. Prasitsuebsai,et al.  Efficacy and tolerability of nevirapine- versus efavirenz-containing regimens in HIV-infected Thai children. , 2008, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[23]  M. Peeters,et al.  Pharmacokinetics (PK) and Pharmacodynamics (PD) of Etravirine (ETR) in Treatment-Experienced HIV-1 Infected Patients: Pooled 48-Week Results of DUET-1 and DUET-2 , 2008 .

[24]  M. Hughes,et al.  Long-term Safety and Efficacy of a Once-Daily Regimen of Emtricitabine, Didanosine, and Efavirenz in HIV-Infected, Therapy-Naive Children and Adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021 , 2007, Pediatrics.

[25]  B. Clotet,et al.  Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial , 2007, The Lancet.

[26]  R. Haubrich,et al.  Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial , 2007, The Lancet.

[27]  D. Gibb,et al.  Adherence and Acceptability of Once Daily Lamivudine and Abacavir in Human Immunodeficiency Virus Type-1 Infected Children , 2006, The Pediatric infectious disease journal.

[28]  A. Walker,et al.  Underdosing of antiretrovirals in UK and Irish children with HIV as an example of problems in prescribing medicines to children, 1997-2005: cohort study , 2006, BMJ : British Medical Journal.

[29]  C. Königs,et al.  Effect of first line therapy including efavirenz and two nucleoside reverse transcriptase inhibitors in HIV-infected children. , 2005, European journal of medical research.

[30]  K. Tashima,et al.  Impact of Efavirenz on Neuropsychological Performance and Symptoms in HIV-Infected Individuals , 2005, Annals of Internal Medicine.

[31]  L. Mofenson,et al.  A trial of three antiretroviral regimens in HIV-1-infected children. , 2004, The New England journal of medicine.

[32]  B. Gazzard,et al.  Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study , 2004, The Lancet.

[33]  K. Korn,et al.  Safety and Efficacy of a Nrti-Sparing Haart Regimen of Efavirenz and Lopinavir/Ritonavir in HIV-1-Infected Children , 2004, Antiviral therapy.

[34]  M. Sharland,et al.  Nevirapine use in HIV-1-infected children , 2003, AIDS.

[35]  D. Dieterich,et al.  Toxicity of non-nucleoside analogue reverse transcriptase inhibitors. , 2003, Seminars in liver disease.

[36]  J. Reynes,et al.  Long‐term assessment of neuropsychiatric adverse reactions associated with efavirenz , 2003, HIV medicine.

[37]  S. Spector,et al.  Efavirenz liquid formulation in human immunodeficiency virus-infected children , 2002, The Pediatric infectious disease journal.

[38]  P. Quartier,et al.  Tolerance of efavirenz in children , 2001, AIDS.

[39]  L. Mofenson,et al.  Patterns of plasma human immunodeficiency virus type 1 RNA response to highly active antiretroviral therapy in infected children. , 2000, The Journal of infectious diseases.

[40]  M. Gersten,et al.  Combination therapy with efavirenz, nelfinavir, and nucleoside reverse-transcriptase inhibitors in children infected with human immunodeficiency virus type 1. Pediatric AIDS Clinical Trials Group 382 Team. , 1999, The New England journal of medicine.

[41]  J. Oleske,et al.  Guidelines for the use of antiretroviral agents in pediatric HIV infection , 1998 .

[42]  P. Krogstad,et al.  Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus type 1 infection. , 1997, The New England journal of medicine.