Alejandro Arenas-Pinto1,2, Wolfgang Stöhr1, Amanda Clarke3, Ian Williams2, Nicholas J Beeching4, Jane Minton5, Vincent Lee6, Nicholas I Paton1,7. 1. MRC-Clinical Trials Unit at UCL, UCL, London, UK. 2. UCL Research Department of Infection and Population Health, UCL, London, UK. 3. The Lawson Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK. 4. Tropical & Infectious Disease Unit, Royal Liverpool University Hospital, Liverpool, UK. 5. Infection and Travel Medicine Services, St James' University Hospital, Leeds, UK. 6. The Northern Sexual Health, Contraception & HIV Service, Royal Infirmary, Manchester, UK. 7. Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Abstract
BACKGROUND: A strategy of protease inhibitor (PI) monotherapy with re-introduction of triple therapy in those who rebound has been shown to be a safe and effective treatment simplification approach for long-term management. We sought evidence for cerebrospinal fluid (CSF) virological escape in patients on long-term PI monotherapy. METHODS: We performed lumbar puncture in asymptomatic participants with suppressed plasma HIV RNA after 96 weeks on the PI monotherapy arm (PI-mono) of the PIVOT trial. We also report CSF HIV RNA concentration in trial participants who were investigated for neurological/neurocognitive symptoms during the trial regardless of study arm allocation. RESULTS:All 11 asymptomatic participants on PI-mono who were tested had undetectable CSF HIV RNA at week 96. One of the three symptomatic participants on PI-mono had CSF HIV RNA of 1,895 copies/ml (undetectable in plasma) and neither of two symptomatic participants on triple therapy had CSF HIV RNA detected. CONCLUSIONS:CSF virological escape appears rare in asymptomatic patients on PI monotherapy and may not warrant routine CSF monitoring, but patients with symptoms merit more concern.
RCT Entities:
BACKGROUND: A strategy of protease inhibitor (PI) monotherapy with re-introduction of triple therapy in those who rebound has been shown to be a safe and effective treatment simplification approach for long-term management. We sought evidence for cerebrospinal fluid (CSF) virological escape in patients on long-term PI monotherapy. METHODS: We performed lumbar puncture in asymptomatic participants with suppressed plasma HIV RNA after 96 weeks on the PI monotherapy arm (PI-mono) of the PIVOT trial. We also report CSF HIV RNA concentration in trial participants who were investigated for neurological/neurocognitive symptoms during the trial regardless of study arm allocation. RESULTS: All 11 asymptomatic participants on PI-mono who were tested had undetectable CSF HIV RNA at week 96. One of the three symptomatic participants on PI-mono had CSF HIV RNA of 1,895 copies/ml (undetectable in plasma) and neither of two symptomatic participants on triple therapy had CSF HIV RNA detected. CONCLUSIONS: CSF virological escape appears rare in asymptomatic patients on PI monotherapy and may not warrant routine CSF monitoring, but patients with symptoms merit more concern.
Authors: Ned Sacktor; Richard L Skolasky; Eric Seaberg; Cynthia Munro; James T Becker; Eileen Martin; Ann Ragin; Andrew Levine; Eric Miller Journal: Neurology Date: 2015-12-30 Impact factor: 9.910
Authors: José R Santos; Josep M Llibre; Isabel Bravo; Dácil García-Rosado; Mari Paz Cañadas; Nuria Pérez-Álvarez; Roger Paredes; Bonaventura Clotet; José Moltó Journal: AIDS Res Hum Retroviruses Date: 2016-02-11 Impact factor: 2.205
Authors: Christine Katlama; Marc A Valantin; Michele Algarte-Genin; Claudine Duvivier; Sidonie Lambert-Niclot; Pierre M Girard; Jean M Molina; Bruno Hoen; Sophie Pakianather; Gilles Peytavin; Anne G Marcelin; Philippe Flandre Journal: AIDS Date: 2010-09-24 Impact factor: 4.177
Authors: Cecile A Delille; Sarah T Pruett; Vincent C Marconi; Jeffrey L Lennox; Wendy S Armstrong; Richard F Arrendale; Anandi N Sheth; Kirk A Easley; Edward P Acosta; Aswani Vunnava; Ighovwerha Ofotokun Journal: J Clin Pharmacol Date: 2014-04-08 Impact factor: 3.126
Authors: Nicholas I Paton; Wolfgang Stöhr; Alejandro Arenas-Pinto; Martin Fisher; Ian Williams; Margaret Johnson; Chloe Orkin; Fabian Chen; Vincent Lee; Alan Winston; Mark Gompels; Julie Fox; Karen Scott; David T Dunn Journal: Lancet HIV Date: 2015-09-14 Impact factor: 12.767
Authors: Kiran T Thakur; Alexandra Boubour; Deanna Saylor; Mitashee Das; David R Bearden; Gretchen L Birbeck Journal: AIDS Date: 2019-02-01 Impact factor: 4.177
Authors: Dami Aderonke Collier; Lewis Haddow; Jay Brijkumar; Mahomed-Yunus S Moosa; Laura Benjamin; Ravindra K Gupta Journal: Brain Sci Date: 2018-10-20
Authors: Ameet N Dravid; Raviraj Gawali; Tarun P Betha; Avadesh K Sharma; Mahenderkumar Medisetty; Kartik Natrajan; Milind M Kulkarni; Chinmay K Saraf; Uma S Mahajan; Sachin D Kore; Niranjan M Rathod; Umakant S Mahajan; Scott L Letendre; Rustom S Wadia; Andrea Calcagno Journal: Medicine (Baltimore) Date: 2020-06-12 Impact factor: 1.817